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Cardiac ArrestNCT04072484

Effectiveness of Chest Compressions Under Mild Hypoxia

A study testing Mild hypoxia in people with Cardiac Arrest and Hypoxia, run by University of Chicago at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to evaluate the effect of breathing a slightly reduced amount of oxygen will have on a rescuer's ability to provide chest compressions during CPR. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Cardiac Arrest, Hypoxia
What is being tested?
Mild hypoxia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteUnited States
Study dates
16 Aug 2019to 1 Oct 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Previous CPR training
  • Baseline exercise tolerance of at least 4 metabolic equivalents (METS)

Who cannot join

  • Heart disease
  • Moderate or severe asthma
  • Carpal tunnel syndrome
  • Mononucleosis
  • Respiratory infections
  • Current injury (e.g., sprain, fracture, or dislocation)
Show all 10Show fewer
  • Acute or chronic muscle or joint pain
  • Recent exposure to high altitude
  • Any other condition that limits physical activity
  • Any condition that precludes flying on a commercial airline flight

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Chicago

    Chicago, Illinois, 60637

Other trials in United States

About this study

Official title: Effectiveness of Chest Compressions Under Mild Hypoxia: Should Rescuers Breathe Supplemental Oxygen on Commercial Flights?

The purpose of this study is to evaluate the effect of breathing a slightly reduced amount of oxygen will have on a rescuer's ability to provide chest compressions during CPR.

Read the detailed description

Cardiac arrest can occur in any setting, even flying on a commercial airliner, and chest compressions are a critical, lifesaving component of cardiopulmonary resuscitation (CPR). If a cardiac arrest occurs on board a commercial flight, CPR may be administered by cabin crew members or health care professionals who are passengers and volunteer their assistance. The in-flight environment presents significant challenges, including an unfamiliar environment, an unknown patient, cramped space, and the fact that the pressure altitude in the cabin is between 6,000 feet and 8,000 feet. Even though the fraction of inspired oxygen (FiO2) is still 0.21, with decreased pressure the rescuer is effectively breathing a FiO2 of 0.15 and is mildly hypoxic. Although the decreased PaO2 seen in even in healthy passengers is a normal occurrence when flying on a commercial airliner, it may impair the ability of a rescuer to perform adequate CPR. Administering supplemental oxygen to the rescuer may enable provision of more effective chest compressions. In this study, we will measure the quality of chest compressions in normoxic and hypoxic conditions during short simulation scenarios. We hypothesize that chest compressions will be more effective in a normoxic environment.

All tasks are being performed for research purposes. All tasks will take place at the University of Chicago in an empty conference room. After the pre-study screening survey, subjects will be asked to perform chest compressions during a simulated cardiac arrest and will then fill out a survey. Subjects will participate in 2 sessions each; the sessions will be at least one day apart. During each session, the subject will wear a face mask. Subjects will be randomized and blinded to one of two conditions: During CPR, the subject will receive a FiO2 of 0.21 or 0.15 by face mask, which will produce a partial pressure of oxygen similar to, but slightly higher than, that of a commercial airliner. The gas mixture will be delivered by a normobaric hypoxia training device. During the second session, subjects will receive the other oxygen concentration.

Each session will consist of a simulation in which a passenger on an airplane (i.e., a mannequin) has an asystolic cardiac arrest. Participants will provide compression-only CPR. Every 2 minutes, the preceptor will ask the subject stop compressions for 10 seconds for a pulse and rhythm check, similar to actual established protocols. The participant will be wearing a pulse oximeter. The scenario will end after 30 minutes (14 rounds of 2 minutes each of CPR by the subject, consistent with the Universal Guidelines for Termination of CPR), or if the subject becomes fatigued and wishes to stop or is no longer providing high quality chest compressions.

Being tested
Mild hypoxia
Medical subject headings
Heart Arrest, Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mild hypoxiaOther

    The subject will breathe a gas mixture containing 15% oxygen instead of 21% oxygen.

Study groups in NCT04072484
Study groupRoleWhat they receive
Room AirNo interventionThe reduced oxygen breathing device will be set to deliver room air. (i.e., no oxygen is removed from the gas mixture. The subject will perform CPR while breathing through mask and tubing that is connected to the device.
HypoxiaExperimentalThe reduced oxygen breathing device will be set to deliver a gas mixture with15% oxygen. (Equivalent to the partial pressure of oxygen at 2,438 meters.) The subject will perform CPR while breathing through mask and tubing that is connected to the device.
Receives: Other: Mild hypoxia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Successful CPR

    Number of successful two-minute CPR rounds

    Measured: 30 minutes

Secondary outcomes (3)

  1. Lowest oxygen saturation

    Lowest oxygen saturation observed during CPR

    Measured: 30 minutes

  2. Survey results - Fatigue

    Participants will rate their level of fatigue on a scale from 0 - 100 (100 = maximum fatigue)

    Measured: 30 minutes

  3. Survey results - Chest compression

    Participants will rate the quality of chest compressions on a scale from 0 - 100 (100 = best chest compressions)

    Measured: 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2019
  2. Study start16 Aug 2019
  3. Primary completion31 Mar 2020
  4. Study completion1 Oct 2020

Why it stopped: Research at the University of Chicago was halted in March 2020.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04072484
Sponsor's protocol ID
IRB19-0535
Status last verified
Nov 2020
First submitted
26 Aug 2019
Last updated
4 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kleinman ME, Goldberger ZD, Rea T, Swor RA, Bobrow BJ, Brennan EE, Terry M, Hemphill R, Gazmuri RJ, Hazinski MF, Travers AH. 2017 American Heart Association Focused Update on Adult Basic Life Support and Cardiopulmonary Resuscitation Quality: An Update to the American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2018 Jan 2;137(1):e7-e13. doi: 10.1161/CIR.0000000000000539. Epub 2017 Nov 6.

    PubMed 29114008

  • Ruskin KJ, Ricaurte EM, Alves PM. Medical Guidelines for Airline Travel: Management of In-Flight Cardiac Arrest. Aerosp Med Hum Perform. 2018 Aug 1;89(8):754-759. doi: 10.3357/AMHP.5038.2018.

    PubMed 30020062

  • Muhm JM. Predicted arterial oxygenation at commercial aircraft cabin altitudes. Aviat Space Environ Med. 2004 Oct;75(10):905-12.

    PubMed 15497372

  • Kwak SJ, Kim YM, Baek HJ, Kim SH, Yim HW. Chest compression quality, exercise intensity, and energy expenditure during cardiopulmonary resuscitation using compression-to-ventilation ratios of 15:1 or 30:2 or chest compression only: a randomized, crossover manikin study. Clin Exp Emerg Med. 2016 Sep 30;3(3):148-157. doi: 10.15441/ceem.15.105. eCollection 2016 Sep.

    PubMed 27752633

  • Romer LM, Haverkamp HC, Amann M, Lovering AT, Pegelow DF, Dempsey JA. Effect of acute severe hypoxia on peripheral fatigue and endurance capacity in healthy humans. Am J Physiol Regul Integr Comp Physiol. 2007 Jan;292(1):R598-606. doi: 10.1152/ajpregu.00269.2006. Epub 2006 Sep 7.

    PubMed 16959862

  • Drennan IR, Case E, Verbeek PR, Reynolds JC, Goldberger ZD, Jasti J, Charleston M, Herren H, Idris AH, Leslie PR, Austin MA, Xiong Y, Schmicker RH, Morrison LJ; Resuscitation Outcomes Consortium Investigators. A comparison of the universal TOR Guideline to the absence of prehospital ROSC and duration of resuscitation in predicting futility from out-of-hospital cardiac arrest. Resuscitation. 2017 Feb;111:96-102. doi: 10.1016/j.resuscitation.2016.11.021. Epub 2016 Dec 5.

    PubMed 27923115

  • Wang JC, Tsai SH, Chen YL, Hsu CW, Lai KC, Liao WI, Li LY, Kao WF, Fan JS, Chen YH. The physiological effects and quality of chest compressions during CPR at sea level and high altitude. Am J Emerg Med. 2014 Oct;32(10):1183-8. doi: 10.1016/j.ajem.2014.07.007. Epub 2014 Jul 30.

    PubMed 25154345

Questions about this trial

What is this clinical trial studying?

A study testing Mild hypoxia in people with Cardiac Arrest and Hypoxia, run by University of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Research at the University of Chicago was halted in March 2020.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Successful CPR (time frame: 30 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04072484, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.

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