CTRI

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CTRI Number

CTRI/2024/08/072738 [Registered on: 20/08/2024] Trial Registered Prospectively

Last Modified On:

27/01/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Medical Device
Process of Care Changes

Study Design

Randomized, Crossover Trial

Public Title of Study

Mechanical ventilation versus bag valve ventilation in adult cardiac arrest patients during CPR

Scientific Title of Study

Six dial mechanical ventilation strategy versus self inflating adult bag valve ventilation in adult cardiac arrest patients undergoing chest compressions- A Randomized Crossover Non-Inferiority trial

Trial Acronym

Nil

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	S Vinay
Designation	Junior Resident
Affiliation	Jawaharlal institute of postgraduate medical education and research
Address	First floor office room, Emergency medicine department, Emergency and trauma care services block, JIPMER, Pondicherry Pondicherry PONDICHERRY 605006 India
Phone	9481717243
Fax
Email	Vinaysannakki1997@gmail.com

Details of Contact Person
Scientific Query

Name	Manu Ayyan S
Designation	Associate professor
Affiliation	Jawaharlal institute of postgraduate medical education and research
Address	First Floor Office room, Emergency medicine department, Emergency and trauma care services block, JIPMER, Pondicherry Pondicherry PONDICHERRY 605006 India
Phone	9846556133
Fax
Email	manuayyan@gmail.com

Details of Contact Person
Public Query

Name	Manu Ayyan S
Designation	Associate professor
Affiliation	Jawaharlal institute of postgraduate medical education and research
Address	First floor office room,EMS building Emergency medicine department, Emergency and trauma care services block, JIPMER, Pondicherry Pondicherry PONDICHERRY 605006 India
Phone	9846556133
Fax
Email	manuayyan@gmail.com

Source of Monetary or Material Support

Jawaharlal institute of postgraduate medical education and research, Pondicherry, PIN code-605006 INDIA

Primary Sponsor

Name	Jawaharlal institute of postgraduate medical education and research
Address	Pondicherry, PIN code-605006
Type of Sponsor	Government medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
S VINAY	Jawaharlal institute of postgraduate medical education and research	1st FLOOR EMS OFFICE, EMERGENCY SERVICES BLOCK. Pondicherry PONDICHERRY	9481717243 Vinaysannakki1997@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
INSTITUTIONAL ETHICS COMMITTEE INTERVENTIONAL STUDIES CDSCO Reg no. ECR/342/Inst/PY/2013/RR-19	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: O\|\|Medical and Surgical,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	SELF INFLATING ADULT BAG VALVE VENTILATION	As it is a randomized cross-over trial the same patient will receive both intervention and the control arm based on the sequence of randomization. Patients who are first randomized to receive breaths from mechanical ventilation, now the patient will be connected to self inflating adult bag valve device. The breath volumes over 10 breaths will be recorded over 1 minute with the help of video recording device pointed at the screen of flow meter.
Intervention	SIX DIAL MECHANICAL VENTILATION STRATEGY	All the eligible adult intubated cardiac arrest patients undergoing cardiopulmonary resuscitation (CPR) who meet the inclusion criteria will be enrolled in the study. Patients who fail to achieve ROSC (Return of spontaneous circulation) and reach termination-of-resuscitation criteria and in whom, continued resuscitation is declared futile by the treating team of emergency physician (who are not part of the study), will be randomized to either Mechanical ventilator or self inflating adult bag valve ventilation arm as per allocation. Patients randomized to Mechanical Ventilator arm (MV) will be ventilated with Hamilton T1 ventilator. The ventilator will be calibrated and checked for leaks. The ventilator setting will be as per six dial strategy. We will set the tidal volume as 8 ml/kg ( predicted if weight unknown - 500ml for male and 400 ml for female), maximum peak inspiratory pressure as 60 cm H2O , FiO2 100%, PEEP 0 cm H2O, Flow trigger off, Respiratory rate 10/min and I:E ratio of 1:5. The primed ventilator will be connected to patient. The breath volumes over 10 breath will be recorded over 1 minute with the help of a video recording device pointed at the screen of the flow meter.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	99.00 Year(s)
Gender	Both
Details	Intubated adult cardiac arrest patients undergoing cardiopulmonary resuscitation in the emergency department and meeting the termination of resuscitation criteria

ExclusionCriteria

Details

1.Age less than 18 years .
2.Pregnant women.
3.Bleeding or secretions in the endotracheal tube.

Method of Generating Random Sequence

Stratified block randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant Blinded

Primary Outcome

Outcome	TimePoints
To compare the efficacy of mechanical ventilator with self inflating adult bag valve ventilation in delivery of tidal volume during cardiopulmonary resuscitation (CPR) in Emergency medicine department.	5 minutes

Secondary Outcome

Outcome	TimePoints
To compare ET CO2 levels on ventilation with mechanical ventilator and bag-valve ventilation.	5 minutes
To compare expiratory tidal volume on ventilation with mechanical ventilator and Bag valve ventilation	5 minutes

Target Sample Size

Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "104"
Final Enrollment numbers achieved (India)="104"

Phase of Trial

Phase 4

Date of First Enrollment (India)

27/08/2024

Date of Study Completion (India)

01/01/2026

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="2"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary
Modification(s)

The American Heart Association estimates that approximately 1000 cardiac arrests occur each day. The American Heart Association updated its recommendations in 2020 and suggested that a tidal volume of approximately 500 to 600 ml, sufficient to cause a visible chest rise, provides adequate ventilation while minimising the risk of overdistension or gastric inflation. Airway management and ventilation during CPR are essential for successful resuscitation in these patients. Studies have compared mechanical ventilation with bag-valve ventilation for gas exchange and have shown that mechanical ventilation is at least feasible and safe for use during CPR in intubated cardiac arrest patients. Another study, using a physical model during simulated cardiopulmonary resuscitation, found that conventional ventilation modes during simulated CPR manoeuvres produced pressures and volumes similar to those reported with bag-valve masks. Studies have yet to be conducted to determine the efficacy of tidal-volume delivery via mechanical ventilation and bag-valve ventilation in cardiac arrest patients. This study will evaluate the efficacy of tidal volume delivery during mechanical ventilation versus bag-valve ventilation in adult intubated cardiac arrest patients undergoing cardiopulmonary resuscitation in the emergency medicine department.