Comparison of adult self-inflating bag versus pediatric self-inflating bag in adult cardiac arrest patients who have been intubated

ISRCTN	ISRCTN10909864
DOI	https://doi.org/10.1186/ISRCTN10909864

Submission date: 12/12/2023
Registration date: 20/12/2023
Last edited: 30/12/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Avoiding excessive ventilation is one of the key components of high-quality cardiopulmonary resuscitation (CPR). European Resuscitation Council (ERC) 2021 guidelines recommend each breath over 1 second just enough to achieve a visible chest rise during CPR to avoid excessive ventilation. American Heart Association (AHA) 2020 guidelines recommend enough tidal volume to cause visible chest rise, or approximately 500 to 600 mL, while minimizing the risk of overdistension or gastric inflation. Adult self-inflating bags are used widely to ventilate cardiac arrest patients. Total volume of the standard adult self-inflating bag is 1600ml. Tidal volume during manual ventilation varies greatly depending on the practitioner thus delivering approximately 600-1000ml. This in turn will lead to excessive ventilation which is harmful during CPR. Thus, this study intends to use pediatric self-inflating bags (750ml). With the usual squeeze of half to 2/3rd of total capacity, the tidal volume delivered is anticipated to be approximately 400-550ml, which would be guideline-consistent for adequate ventilation during CPR. This study will enlighten us regarding the average tidal volume being delivered by adult and pediatric self-inflating bags during CPR.

Who can participate?
Adult patients (above 18 years old) experiencing cardiac arrest

What does the study involve?
The study will commence after obtaining approval from the Institute Ethics Committee. Adult patients (above 18 years) experiencing cardiac arrest will be treated according to standard guidelines in the emergency department. All eligible patients will be included in the study.

During standard CPR, a flow analyzer will be connected between the endotracheal tube and the adult self-inflating bag. This device records ventilatory metrics such as inspired and expired tidal volume, peak flow, inspiratory time, and breaths per minute over 2 minutes, with the display monitor covered.

For patients achieving a return of spontaneous circulation (ROSC), post-cardiac arrest care will be provided. For those failing to achieve ROSC and meeting termination-of-resuscitation criteria, and when resuscitation is deemed futile by the treating physicians, CPR will be extended for 2 minutes using a pediatric self-inflating bag. Ventilatory metrics will be recorded for the pediatric bag, and the tidal volume required for visible chest rise will be considered the ideal tidal volume for that patient.

This study aims to compare the ideal tidal volume with the average tidal volumes delivered by adult and pediatric self-inflating bags.

What are the possible benefits and risks of participating?
As the study is performed on a cardiac arrest patient who reaches the termination of the resuscitation criteria - the patient would neither benefit nor be harmed. There is no anticipated risk except the waiver of consent.

Where is the study run from?
Jawaharlal Institute of Postgraduate Medical Education and Research (India)

When is the study starting and how long is it expected to run for?
August 2022 to January 2024

Who is funding the study?
Jawaharlal Institute of Postgraduate Medical Education and Research (India)

Who is the main contact?
Dr Kowsthubha B G, beingmedico149@gmail.com, jr7374@jipmer.ac.in (India)

Contact information

Dr Kowsthubha B G
Public, Scientific, Principal Investigator

Emergency Medicine and Trauma
EMS Block, JIPMER
JIPMER Campus Road, Danavanthari Nagar
Puducherry
605006
India

ORCID ID	0009-0006-7909-7248
Phone	+919008801986
Email	jr7374@jipmer.ac.in

Dr Manu Ayyan S
Public, Scientific

Associate professor
Emergency medicine and trauma
EMS Block, JIPMER
JIPMER Campus Road, Danavanthari Nagar
Puducherry
605006
India

ORCID ID	0000-0002-2541-5769
Phone	+919846556133
Email	manuayyan.s.jir@nic.in

Dr Anandhi Devendiran
Public, Scientific

Puducherry
Puducherry
605006
India

ORCID ID	0000-0003-3498-6392
Phone	+919626064984
Email	anandhideva1@gmail.com

Dr Kowsthubha B G
Public

Emergency Medicine and Trauma
EMS Block, JIPMER
JIPMER Campus Road, Danavanthari Nagar
Puducherry
605006
India

Phone	+919008801986
Email	beingmedico149@gmail.com

Dr Manu Ayyan S
Public

Associate professor
Emergency medicine and trauma
EMS Block, JIPMER
JIPMER campus road, danavanthari nagar
Puducherry
605006
India

Phone	+919846556133
Email	manuayyan@hotmail.com

Study information

Study design	Clinical prospective non-randomized interventional study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	University/medical school/dental school
Study type	Treatment
Participant information sheet	Participant information can be found at: https://docs.google.com/forms/d/e/1FAIpQLSdWFKYKCJSt8khU-8CZCowKJJJ0Sn3JbfCs6dvIEvC9JGr8dg/viewform?usp=sf_link
Scientific title	Extended cardiopulmonary resuscitation using a pediatric self-inflating bag in adult cardiac arrest patients reaching termination-of-resuscitation criteria – a prospective interventional study
Study objectives	Expected outcome and application The tidal volumes provided by standard adult self-inflating bags may be causing harm in practical use. 1. This study will enlighten us regarding the average tidal volume being delivered by an adult self-inflating bag during CPR. 2. Pediatric self-inflating bags are expected to deliver appropriate tidal volume to ventilate intubated adult cardiac arrest patients. 3. The ideal tidal volume required to achieve a visible chest rise in adult cardiac arrest patients will be known which will help us to determine if a pediatric or adult self-inflating bag delivers guideline-consistent ventilation.
Ethics approval(s)	Approved 06/08/2022, Institutional Ethics Committee (Human studies) for Intervention studies (Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006, India; +91 0413-2277278; research@jipmer.edu.in), ref: JIP/IEC/2022/034
Health condition(s) or problem(s) studied	Airway management during adult extended CPR using an adult inflating bag versus a pediatric self-inflating bag
Intervention	The study will be started after obtaining the Institute Ethics Committee's Approval. Adult patients (>18 years) in cardiac arrest will be resuscitated as per standard recommended guidelines in the emergency department. All eligible patients will be enrolled in the study. When conventional CPR is in progress, a flow analyser (with the display monitor covered by an opaque plaster) will be connected between the endotracheal tube and the adult self-inflating bag (1600 ml). Ventilatory metrics (inspired and expired tidal volume, peak flow, inspiratory time, breaths per minute) delivered by an adult self-inflating bag with ongoing chest compressions will be recorded over 2 minutes and average measurements will be noted. 1. Patients who achieve a return of spontaneous circulation (ROSC) will receive post-cardiac arrest as per care 2. For Patients who fail to achieve ROSC, reach termination-of-resuscitation criteria and in whom, continued resuscitation is declared futile by the treating team of physicians (who are not part of the study), CPR will be extended for 2 minutes using a pediatric self-inflating bag (750 ml) to ventilate. Ventilatory metrics (inspired & expired tidal volume, peak flow, inspiratory time, breaths per minute) delivered by the pediatric self-inflating bag with ongoing chest compressions will be recorded over 2 minutes and average measurements will be noted. The tidal volume required to achieve a visible chest rise will be considered the ideal tidal volume of that patient. The ideal tidal volume will be compared with the average tidal volume delivered by adult and pediatric self-inflating bags.
Intervention type	Device
Pharmaceutical study type(s)	Not Applicable
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Pediatric self-inflating bag, adult self-inflating bag
Primary outcome measure	To compare the inspired and expired tidal volumes delivered using an adult self-inflating bag with that of the pediatric self-inflating bag during cardiopulmonary resuscitation of adults
Secondary outcome measures	To estimate the average tidal volume required to achieve a visible chest rise over 1 second in adult cardiac arrest patients
Overall study start date	01/08/2022
Completion date	07/01/2024

Eligibility

Participant type(s)	Patient
Age group	Mixed
Lower age limit	18 Years
Upper age limit	99 Years
Sex	Both
Target number of participants	130
Total final enrolment	130
Key inclusion criteria	Intubated adult (> 18 years) cardiac arrest patients undergoing cardiopulmonary resuscitation in the Emergency Department
Key exclusion criteria	1. Pregnant women 2. Bleeding or secretions in the endotracheal tube 3. Non-availability of flow analyzer
Date of first enrolment	10/10/2022
Date of final enrolment	20/12/2023

Locations

Countries of recruitment

India

Study participating centre

Jawaharlal Institute of Postgraduate Medical Education and Research

JIPMER Campus Rd, Gorimedu
Dhanvantari Nagar
Puducherry
605006
India

Sponsor information

Jawaharlal Institute of Post Graduate Medical Education and Research
University/education

Jipmer campus road
Dhanvantharinagar
Puducherry
605006
India

Phone	+91 04132296562
Email	research@jipmer.edu.in
Website	http://jipmer.edu.in/
"ROR"	https://ror.org/02fq2px14

Funders

Funder type

University/education

Jawaharlal Institute Of Postgraduate Medical Education and Research
Government organisation / Local government

Alternative name(s): JIPMER
Location: India

Results and Publications

Intention to publish date	07/06/2024
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Kowsthubha B G, jr7374@jipmer.ac.in. The data available are the patient details, diagnosis and volume metrics while using adult and pediatric self-inflating bags. In this study, the rapidity with which the treatment is needed for cardiac arrest precludes obtaining consent from family members/ bystanders/ legally authorized representatives Also, considering the emotional stress state of grieving family members and/ or next of kin, seeking informed consent when CPR is in progress seems impractical, if not impossible. Hence the study can only be conducted with a waiver of informed consent.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Other unpublished results			30/12/2024	No	No

Additional files

ISRCTN10909864_UnpublishedResults.pdf

Editorial Notes

30/12/2024: Unpublished results added.
15/12/2023: Study's existence confirmed by the Jawaharlal Institute Of Postgraduate Medical Education and Research (India).