NCT04072484

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 16, 2019

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

8 months

First QC Date

August 26, 2019

Last Update Submit

November 2, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Successful CPR

    Number of successful two-minute CPR rounds

    30 minutes

Secondary Outcomes (3)

  • Lowest oxygen saturation

    30 minutes

  • Survey results - Fatigue

    30 minutes

  • Survey results - Chest compression

    30 minutes

Study Arms (2)

Room Air

NO INTERVENTION

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.

Hypoxia

EXPERIMENTAL

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

Interventions

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

Hypoxia

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (7)

  • 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.

    PMID: 29114008BACKGROUND
  • 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.

    PMID: 30020062BACKGROUND
  • Muhm JM. Predicted arterial oxygenation at commercial aircraft cabin altitudes. Aviat Space Environ Med. 2004 Oct;75(10):905-12.

    PMID: 15497372BACKGROUND
  • 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.

    PMID: 27752633BACKGROUND
  • 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.

    PMID: 16959862BACKGROUND
  • 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.

    PMID: 27923115BACKGROUND
  • 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.

    PMID: 25154345BACKGROUND

MeSH Terms

Conditions

Heart ArrestHypoxia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Keith J Ruskin, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participant is unaware of the oxygen concentration that he or she is breathing during either arm of the trial.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2019

First Posted

August 28, 2019

Study Start

August 16, 2019

Primary Completion

March 31, 2020

Study Completion

October 1, 2020

Last Updated

November 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations