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Effectiveness of Chest Compressions Under Mild Hypoxia

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ClinicalTrials.gov Identifier: NCT04072484
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Brief 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.

Condition or disease Intervention/treatment Phase
Cardiac Arrest Hypoxia Other: Mild hypoxia Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Masking Description: The participant is unaware of the oxygen concentration that he or she is breathing during either arm of the trial.
Primary Purpose: Prevention
Official Title: Effectiveness of Chest Compressions Under Mild Hypoxia: Should Rescuers Breathe Supplemental Oxygen on Commercial Flights?
Actual Study Start Date : August 16, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
No Intervention: Room Air
The 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.
Experimental: Hypoxia
The 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.
Other: Mild hypoxia
The subject will breathe a gas mixture containing 15% oxygen instead of 21% oxygen.




Primary Outcome Measures :
  1. Successful CPR [ Time Frame: 30 minutes ]
    Number of successful two-minute CPR rounds


Secondary Outcome Measures :
  1. Lowest oxygen saturation [ Time Frame: 30 minutes ]
    Lowest oxygen saturation observed during CPR

  2. Survey results - Fatigue [ Time Frame: 30 minutes ]
    Participants will rate their level of fatigue on a scale from 0 - 100 (100 = maximum fatigue)

  3. Survey results - Chest compression [ Time Frame: 30 minutes ]
    Participants will rate the quality of chest compressions on a scale from 0 - 100 (100 = best chest compressions)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Heart disease
  • Moderate or severe asthma
  • Carpal tunnel syndrome
  • Mononucleosis
  • Respiratory infections
  • Current injury (e.g., sprain, fracture, or dislocation)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04072484


Contacts
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Contact: Keith J Ruskin, MD (773)-834-2369 ruskin@uchicago.edu

Locations
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United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Keith J Ruskin, MD    773-834-2369    ruskin@uchicago.edu   
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Keith J Ruskin, MD University of Chicago

Publications:

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT04072484     History of Changes
Other Study ID Numbers: IRB19-0535
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory
Signs and Symptoms