Effectiveness of Chest Compressions Under Mild Hypoxia

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.

Study Overview

• Status: Terminated
• Conditions: Hypoxia; Cardiac Arrest
• Intervention / Treatment: Other: Mild hypoxia

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University Of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful CPR	Number of successful two-minute CPR rounds	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lowest oxygen saturation	Lowest oxygen saturation observed during CPR	30 minutes
Survey results - Fatigue	Participants will rate their level of fatigue on a scale from 0 - 100 (100 = maximum fatigue)	30 minutes
Survey results - Chest compression	Participants will rate the quality of chest compressions on a scale from 0 - 100 (100 = best chest compressions)	30 minutes

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Keith J Ruskin, MD, University Of Chicago

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2019
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: August 26, 2019
• First Submitted That Met QC Criteria: August 27, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: IRB19-0535

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No