How does the ResQPOD Circulatory Enhancer improve circulation during cardiopulmonary resuscitation (CPR)?
The ResQPOD utilizes the interdependence of the body’s respiratory and circulatory systems to create a vacuum (negative pressure) within the chest during the recoil phase of CPR, which follows each chest compression. The ResQPOD prevents the influx of respiratory gases into the chest during the chest wall recoil (relaxation or decompression) phase, which lowers the intrathoracic pressure and draws more venous blood back to the heart. Improved blood return to the heart (preload) results in improved blood flow out of the heart (cardiac output) during the subsequent compression.

What are the intrathoracic pressure levels found during inspiration in a healthy, spontaneously breathing person compared to the decompression phase of CPR in a cardiac arrest patient receiving standard CPR alone and to a patient receiving CPR in conjunction with the ResQPOD Circulatory Enhancer?
Average intrathoracic pressure:


In a healthy, spontaneously breathing person at rest are approximately -1.4 to -3 cmH2O;
In a cardiac arrest patient who is receiving standard CPR, varies from -1.4 to -8 cmH2O;
In a cardiac arrest patient who is receiving active compression decompression (ACD) CPR with the ResQPOD in place, varies from approximately –10 to -16 cmH2O.

The greater the negative intrathoracic pressure (vacuum), the more blood that returns to the heart. However, it should be noted that excessive negative pressures can be detrimental. The ResQPOD has been specifically designed to safely optimize the degree of negative pressure for maximum blood return to the heart.

Is the ResQPOD effective with standard and active compression decompression (ACD) CPR? What about mechanical CPR devices (e.g. AutoPulse or Thumper)?
The combination of animal and human studies have shown statistically significant improvements in blood pressure, vital organ circulation and survival rates from cardiac arrest and normal neurological function when an impedance threshold device is used in conjunction with standard and ACD CPR.
1, 2, 3, 4, 5, 6, 7, 8 It can be used with any method of CPR that uses traditional types of airway adjuncts. The manufacturer has experience in using an ITD with the Thumper (Michigan Instruments) and LUCAS device (Jolife), but no experience with the AutoPulse (Revivant).

Does the ResQPOD Circulatory Enhancer interfere with the patient’s ability to exhale?
No, the ResQPOD provides insignificant resistance to patient exhalation. Expired air leaves the patient through the ventilation port.

Does the ResQPOD limit the rescuer’s ability to ventilate the patient?
No, the patient may be freely ventilated, at whatever compression to ventilation ratio and tidal volume the situation dictates.

Is hyperventilation helpful during CPR?
The natural tendency when performing CPR is to ventilate the patient frequently. Contrary to common practice, hyperventilation is very detrimental during CPR. Each extra breath interferes with the development of negative intrathoracic pressure created during the chest wall recoil (or decompression) phase. Thus, hyperventilation, that is, ventilation more often than 10 times/minute, markedly reduces the efficiency of all methods of CPR, with or without the ResQPOD. Hyperventilation during use of the ResQPOD will prevent the intrathoracic pressure levels from going below zero, resulting in diminished venous return to the chest. This is a fundamental point that must be heavily emphasized when training rescuers on how to perform any method of CPR and use the ResQPOD.

Will the ResQPOD hinder patients who begin to breathe spontaneously?
Patients who begin to breathe on their own will have to overcome the “opening pressure” of the ResQPOD’s resistance regulation system (approx. -10 cmH2O) before air will be allowed to enter the device. For this reason, the ResQPOD should be removed immediately from the respiratory circuit when enhanced circulation is no longer needed.

What effect does altitude have on the ResQPOD Circulatory Enhancer’s function; i.e. can it be used in aero medical or submarine environments?
No effect. Altitude does not effect on the ResQPOD’s performance.

What effect will breath stacking (delivering a series of breaths without compressions in between) have on the ResQPOD’s function?
Breath stacking will delay the effect of the ResQPOD, as the pressure within the chest is higher after breath stacking. It is for that reason that the ERC and AHA guidelines recommend a 15:2 compression to ventilation ratio. In intubated patients, we recommend an 10:1 compression to ventilation ratio (equivalent to 10 ventilations/minute at the AHA-recommended compression rate of 100/min), which is consistent with ERC and AHA Guidelines.

Silicone valves are known to stick when they become warm and wet from respiration – especially diaphragm valves. Does the ResQPOD Circulatory Enhancer remain functional in extreme temperatures and humidity?
Yes, the ResQPOD has been tested under extreme temperature and humidity conditions and remains functional as indicated in the product’s packaging and labeling.

I’ve been doing CPR on the job for years, why should I use the timing assist lights?
Ventilating at the proper rate is critical to the success during CPR, with or without the ResQPOD. Even among experienced rescuers, there is a tendency to ventilate patients too frequently during cardiac arrest. While proper ventilation is important, hyperventilation diminishes the opportunity for the ResQPOD to be effective, because each time you give a breath, you destroy the vacuum that is being created in the chest during chest compressions. Studies have shown that even the most experienced healthcare providers perform proper CPR only about 20% of the time and that devices that provide rate guidance lead to a significant improvement in technique. The timing assist lights are designed to encourage a ventilation rate of 10/minute, which is consistent with the American Heart Association (AHA) guidelines for patients with a secured airway. The timing light function is not linked in any way to the device’s inspiratory impedance feature, so, if for some reason the timing lights fail to blink, the device still provides inspiratory impedance. If the AHA comes out with revised guidelines for recommended ventilation rates in the future, the timing light flash rate will be adjusted accordingly.
If the timing assist lights flash at 10/min (at 6 second intervals), how do I use them during CPR with an unsecured airway?
The timing assist lights are really intended to promote the proper rate during ventilation with a secured airway, where it is recommended that compressions and ventilations are performed asynchronously (independent of each other). During CPR with a facemask, rescuers are encouraged to perform CPR with the ResQPOD in place but without the timing assist lights activated. Minimal interruptions in chest compression result in enhanced circulation. The person performing chest compressions should count out loud to 15, then pause compressions to allow 2 ventilations. Ventilations more often than every 15 compressions are NOT recommended.

Do the batteries in the ResQPOD create an environmental disposal issue?
The timing assist lights on the ResQPOD are powered by lithium batteries and do not pose an overall environmental threat. Dispose of the ResQPOD as you would lithium batteries. Check individual country regulations regarding disposal.

Does the ResQPOD provide positive end expiratory pressure (PEEP)?
No.

Can the ResQPOD be reused?
No, the ResQPOD is a single patient use product and is marked with the ISO international symbol for single use. The number of parts and their tight specifications, along with the various material components do not allow the ResQPOD to be disassembled, disinfected and reassembled for reuse.

It has been demonstrated that flow rates above 40 L/min can cause gastric distension when using a bag-valve mask. Does the ResQPOD Circulatory Enhancer limit ventilation flow rates to less than 40 L/min?
No, there is no significant airflow resistance through the ResQPOD during ventilation by the rescuer. In patients who are intubated, gastric distension is not a concern during ventilation and each breath should be delivered quickly (over 1 second), with enough tidal volume to cause chest rise. In patients who are not intubated, ventilation sources that deliver greater than 40 L/min flow rates can cause gastric distension. To prevent this, the ERC and AHA recommend that rescuers using bag-valve resuscitators deliver slow (over 2 seconds), gentle breaths at selected tidal volumes (preferably 6 to 7 ml/kg) and that manually triggered, oxygen-powered devices (demand-valve resuscitators) have flow restrictors that limit their flow rate to 40 L/min. For ventilation delivered via mouth to mask, rescuers are instructed to deliver a slow (over 2 seconds) breath until the chest rises.

How much inspiratory impedance does the ResQPOD provide?
The valving mechanism within the ResQPOD creates a selective resistance to the influx of air until a pressure of approximately -10 cmH2O is reached, at which time the valves open to allow respiratory gases in.

What is the ResQPOD’s shelf life?
Two years from the date of manufacture.

The ResQPOD is contraindicated in dilated cardiomyopathy, congestive heart failure, pulmonary hypertension, aortic stenosis, flail chest, chest pain and shortness of breath. What does this mean for patients in cardiac arrest?
Often times in cardiac arrest, the exact pre-existing medical condition of the patient is unknown. Blood flow and circulation during cardiac arrest is known to be poor. For patients who are in need of circulatory support because they are in cardiac arrest and receiving CPR, you can use the ResQPOD as a circulatory enhancer. The ResQPOD is not contraindicated for patients in cardiac arrest receiving CPR. These patients have an 80 - 90% or more chance of dying secondary to low circulation due to cardiac arrest, which is their primary medical problem. One can use the ResQPOD to help treat this primary problem. Once that problem has been effectively treated, then the ResQPOD may no longer be indicated or appropriate in view of the listed contraindications; thus, we recommend removing it when not performing CPR, once a pulse has been obtained. The prescribing physician should make the final determination about when the ResQPOD is used.

Is chest trauma a contraindication for use of the ResQPOD Circulatory Enhancer?
The only trauma-related contraindication to ResQPOD use is a flail chest.

What effect will the ResQPOD Circulatory Enhancer have during resuscitation on patients with an open or closed pneumothorax?
Any “leak” in the chest cavity will interfere with the generation of negative pressures. In patients with open pneumothoraces, rescuers are taught to cover the wound with a one-way seal that allows air to escape from the chest but not to enter. Assuming there is not a one-way flap in place, the ResQPOD will not affect an open pneumothorax. In a closed pneumothorax, positive pressure ventilation is dangerous, but we are not aware of any mechanism by which the ResQPOD could significantly worsen a closed pneumothorax.

Does the ResQPOD Circulatory Enhancer have any effect on intracranial pressure and are there any specific recommendations for patients with head injuries?
In animal models of cardiac arrest, use of an ITD lowers intracranial pressure and results in overall improvement in cerebral perfusion pressures.9 Though the ResQPOD has not been specifically tested in patients with head injuries, the manufacturer is not aware of any contraindications for use in patients with head injuries.
Can I use the ResQPOD Circulatory Enhancer on children?
The AHA and ERC guidelines recommend adult CPR procedures for patients ages 8 years and above.10 The ResQPOD should be effective in patients of all ages, however it has only been tested clinically in adults ages 18 years and above. Animal studies in a pediatric model of cardiac arrest, have demonstrated that the ResQPOD effectively enhances circulation in 10 kg piglets in cardiac arrest. If there is not a good seal between the airway device and the lungs, the ResQPOD may be less effective. As long as there is an adequate seal during positive pressure ventilation, the ResQPOD should work effectively. It is the ultimate decision of the prescribing physician to determine in what ages of patients the ResQPOD should be used.

I’ve noticed that the ResQPOD adds some height and weight to the ventilation circuit. Should I be concerned at all about the tube dislodging?
The ResQPOD does add some height and weight to the ventilation circuit. For this reason, ACSI strongly recommends that the user uses a commercially available tube restraint device when using the ResQPOD. We do not advocate using tape for this purpose. Prior to attaching the ResQPOD, the tube’s placement should be confirmed. The same care should be taken with the ResQPOD as when using a resuscitator bag alone: secure the tube will and reassess frequently.

Has the AHA made any recommendations on the ResQPOD?
Yes, the Impedance Threshold Device (e.g., ResQPOD) was recommended by the AHA in 2005 as follows: "When the ITD (Impedance Threshold Device) is used by trained personnel as an adjunct to CPR in intubated adult cardiac arrest patients, it can improve hemodynamic parameters and ROSC (Return of Spontaneous Circulation)." 12
An AHA Class IIa recommendation means that the weight of evidence supports the action or therapy and the therapy is considered acceptable and useful.

Does the ResQPOD Circulatory Enhancer have 510(k) clearance from the FDA?
Yes; the ResQPOD Circulatory Enhancer is indicated for home, hospital, clinic and emergency care use, for the temporary increase in blood circulation as directed by a physician or licensed practitioner. It is contraindicated in dilated cardiomyopathy, congestive heart failure, pulmonary hypertension, aortic stenosis, flail chest, chest pain and shortness of breath. It can be used with a facemask, endotracheal tube or other appropriate airway adjunct used for assisted ventilation. The ResQPOD Circulatory Enhancer can be used in patients requiring assisted ventilation, for example, patients receiving CPR.


Does the ResQPOD Circulatory Enhancer, Cardiac Arrest have the CE mark?
Yes.

Who is your regulatory representative in the EU?
The regulatory representative for Advanced Circulatory Systems, Inc. is CEPartner4U, 3951DB;13.NL, telephone: +31(0) 6516.536.26.

12 2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care; Circulation 2005; Vol: 112, Issue 24 Supplement;
Dec. 13 2005.

Does the ResQPOD Circulatory Enhancer comply with International Standard Organization (ISO) anaesthetic connection standards?
Yes, the ResQPOD is in full compliance of ISO 5356-1, Anaesthetic and respiratory equipment – conical connectors.
What effect does adding a PEEP valve to the ventilation circuit (distal or proximal) have on the ResQPOD Circulatory Enhancer?
PEEP is compatible with the ResQPOD. If it is used, it should be placed between the ResQPOD and the ventilation source, not between the ResQPOD and the airway. One animal study has shown that low levels of PEEP may improve the efficiency of CPR with the ResQPOD 11 , but there are no human studies evaluating both the ResQPOD and PEEP to date.

What effect does adding continuous positive airway pressure (CPAP) to the ventilation circuit (distal or proximal) have on the ResQPOD?
CPAP is not compatible with the ResQPOD because it is not possible to lower intrathoracic pressure with CPAP. CPAP is contraindicated during CPR as it decreases venous blood flow back to the heart. CPAP should not be used during the performance of CPR, with or without the ResQPOD.

What effect does adding bi-level positive airway pressure (BiPAP) to the ventilation circuit (distal or proximal) have on the ResQPOD Circulatory Enhancer?
BiPAP is not compatible with the ResQPOD because any continuous positive airway pressure ventilation negates most of the effects of the ResQPOD during cardiac arrest.

Can I use the ResQPOD Circulatory Enhancer with a colormetric end tidal carbon dioxide (ETCO2) detector in the ventilation circuit to assess endotracheal (ET) tube placement or with a bag-valve resuscitator that incorporates ETCO2 detection as a feature (e.g. Capno-Flo [Mallinkrodt])?
Yes. The colormetric test results may be more positive with the ResQPOD in place if the ET is in the proper position. Place the colormetric ETCO2 detector between the ResQPOD and the ventilation source, making sure all connections are tight and do not leak.

Can I use electronic ETCO2 detection (with sidestream or mainstream gas sampling) in the same ventilation circuit as the ResQPOD Circulatory Enhancer?
Yes, as long as the sensor is placed between the ResQPOD and the ventilation source and not between the ResQPOD and the airway, which could create an air leak and, therefore, hinder the development of the vacuum.

Can I use the ResQPOD Circulatory Enhancer with bag-valve resuscitators that have an integrated "mediport" (feature that permits administration of medications via a metered dose inhaler) or to administer medications endotracheally (e.g. Medibag, Ambu)?
Yes, the ResQPOD should not affect the delivery of the medication and the medication should not affect the performance of the ResQPOD. However, this has not been clinically tested and may depend upon the medication used. If you are delivering endotracheal medications without a mediport, the manufacturer recommends that you disconnect the ResQPOD from the endotracheal (ET) tube, administer the medications directly into the ET tube, and then reconnect the ResQPOD.

Can the ResQPOD Circulatory Enhancer be used with a bag-valve resuscitator with a feature that limits flow rates (and thus airflow pressures) during ventilation (e.g. SMART BAG)?
Yes. This feature will not affect the ResQPOD’s function.

Can I use the ResQPOD with the Oxylator?
No. In the automatic mode, the Oxylator provides a continuously positive airway pressure that is harmful for the patient, with or without the ResQPOD. This continuously positive airflow interferes with the ResQPOD’s ability to create a vacuum (negative pressure). ACSI and the American Heart Association discourage the use of the Oxylator in the automatic mode during CPR, it will decrease circulation.

Can the ResQPOD Circulatory Enhancer be used on a patient with a tracheostomy or stoma?
A patient with a stoma could have an endotracheal tube placed into the stoma for airway management. If there is not a good seal between the airway device and the lungs, the ResQPOD may be less effective. As long as there is an adequate seal during positive pressure ventilation, the ResQPOD should work effectively. It is the ultimate decision of the prescribing physician to determine in what ages of patients the ResQPOD should be used.

Can the ResQPOD Circulatory Enhancer be used on an uncuffed endotracheal tube?
If there is not a good seal between the airway device and the lungs, the ResQPOD may be less effective. As long as there is an adequate seal during positive pressure ventilation, the ResQPOD should work effectively. It is the ultimate decision of the prescribing physician to determine in what ages of patients the ResQPOD should be used.

Can the ResQPOD Circulatory Enhancer be used with any standard facemask?
Yes; however, the manufacturer strongly recommends that the user consider the quality of the facemask to use it with. Obtaining and maintaining an adequate seal during facemask ventilation is critically important to the generation of the all-important vacuum. Many standard facemasks purchased today are selected primarily based upon cost, not mask quality. ACSI recommends that anyone who is going to use the ResQPOD on a facemask use one with excellent face-sealing qualities. A 2-person ventilation technique, as recommended by the American Heart Association, is preferred.

The current model of ResQPOD requires a 15 mm/22 mm adaptor in order to attach it to a standard facemask; no adaptor is required for connection to an endotracheal tube. At the present time, the ResQPOD comes packaged with this adaptor. Sometime in the summer of 2005, the next model of ResQPOD will come out (same product number). This model will not require an adaptor for connection to any airway adjunct and will have two timing assist lights instead of three. A special sticker will be placed on the packaging so that the user will know that an adaptor is no longer required.

I see that the ResQPOD can be used for mouth-to-mask ventilation, but the ResQPOD doesn’t come packaged with a mouthpiece. How can I get one?
Most mouthpieces with standard adaptors will work. One source for mouthpieces that will work with the ResQPOD is: Qosina, 150-Q Executive Drive, Edgewood, NY 11717-8329; phone: 631-242-3000; fax: 631-242-3230; website: www.qosina.com; product name: 22 mm OD mouthpiece; part #: 55901.

Can I use the ResQPOD Circulatory Enhancer on a Combitube, laryngeal mask airway (LMA), esophageal obturator airway (EOA), Cobra, or other advanced airway?
The ResQPOD is cleared for use on airway adjuncts used during assisted ventilation. The ResQPOD will fit on these advanced airway devices and should be effective as long as there is a sufficient seal within the ventilation circuit.

Has the ResQPOD Circulatory Enhancer been tested with semi-open anesthetic circuits (e.g. Bain, McGill, Lack) as these are used in emergency resuscitation rooms connected to resuscitation machines?
The ResQPOD has not been tested in semi-open anesthetic circuits; however, there is no known reason that the ResQPOD should not work with these machines.

Has the ResQPOD Circulatory Enhancer been tested with Soda Lime Absorber “Closed Circuit” anesthetic systems, which are also used in resuscitation areas?
The ResQPOD has not been tested in closed circuit anesthetic systems; however, there is no reason to believe that the ResQPOD would not work.

When expiration release pressures are high, minute volume dividers and pressure-cycled resuscitators may respond with a high respiratory rate and low breath volumes. Most EMS ventilators and BVM devices can be fitted with a break valve pressure of between 45 and 60 cmH2O. Does this affect ResQPOD performance?
This should not alter the performance of the ResQPOD.

Does the application of cricoid pressure interfere with ResQPOD performance?
No.