Effectiveness of Chest Compressions Under Mild Hypoxia

NCT ID: NCT04072484

Last Updated: 2020-11-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-16
• Study Completion Date: 2020-10-01

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.

Conditions

Cardiac Arrest; Hypoxia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Mild hypoxia

Intervention Type: OTHER

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

Interventions

Mild hypoxia

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Keith J Ruskin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago

Chicago, Illinois, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 29114008 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 25154345 (View on PubMed)

Other Identifiers

IRB19-0535

Identifier Type: -

Identifier Source: org_study_id