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Effectiveness of Chest Compressions Under Mild Hypoxia

Primary Purpose

Cardiac Arrest, Hypoxia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mild hypoxia
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiac Arrest

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Room Air

Hypoxia

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Successful CPR
Number of successful two-minute CPR rounds

Secondary Outcome Measures

Lowest oxygen saturation
Lowest oxygen saturation observed during CPR
Survey results - Fatigue
Participants will rate their level of fatigue on a scale from 0 - 100 (100 = maximum fatigue)
Survey results - Chest compression
Participants will rate the quality of chest compressions on a scale from 0 - 100 (100 = best chest compressions)

Full Information

First Posted
August 26, 2019
Last Updated
November 2, 2020
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT04072484
Brief Title
Effectiveness of Chest Compressions Under Mild Hypoxia
Official Title
Effectiveness of Chest Compressions Under Mild Hypoxia: Should Rescuers Breathe Supplemental Oxygen on Commercial Flights?
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
Research at the University of Chicago was halted in March 2020.
Study Start Date
August 16, 2019 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Hypoxia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Masking Description
The participant is unaware of the oxygen concentration that he or she is breathing during either arm of the trial.
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Room Air
Arm Type
No Intervention
Arm Description
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.
Arm Title
Hypoxia
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Mild hypoxia
Intervention Description
The subject will breathe a gas mixture containing 15% oxygen instead of 21% oxygen.
Primary Outcome Measure Information:
Title
Successful CPR
Description
Number of successful two-minute CPR rounds
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Lowest oxygen saturation
Description
Lowest oxygen saturation observed during CPR
Time Frame
30 minutes
Title
Survey results - Fatigue
Description
Participants will rate their level of fatigue on a scale from 0 - 100 (100 = maximum fatigue)
Time Frame
30 minutes
Title
Survey results - Chest compression
Description
Participants will rate the quality of chest compressions on a scale from 0 - 100 (100 = best chest compressions)
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith J Ruskin, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29114008
Citation
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. Erratum In: Circulation. 2018 Jan 2;137(1):e14.
Results Reference
background
PubMed Identifier
30020062
Citation
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.
Results Reference
background
PubMed Identifier
15497372
Citation
Muhm JM. Predicted arterial oxygenation at commercial aircraft cabin altitudes. Aviat Space Environ Med. 2004 Oct;75(10):905-12. Erratum In: Aviat Space Environ Med. 2010 May;81(5):532.
Results Reference
background
PubMed Identifier
27752633
Citation
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.
Results Reference
background
PubMed Identifier
16959862
Citation
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.
Results Reference
background
PubMed Identifier
27923115
Citation
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.
Results Reference
background
PubMed Identifier
25154345
Citation
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.
Results Reference
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Effectiveness of Chest Compressions Under Mild Hypoxia

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