Safe Use of CPAP and PEEP During Induction of General Anesthesia

Sponsor

Region Västmanland (Other)

Overall Status

Completed

CT.gov ID

NCT04271683

Collaborator

(none)

Enrollment

Location

Arms

2.1

Actual Duration (Months)

33.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study compares the safety of using pressure controlled ventilation with a positive end-expiratory pressure (PEEP) during induction of general anaesthesia immediately after apnoea to a standard method starting ventilation manually without PEEP immediately after apnoea.

Condition or Disease	Intervention/Treatment	Phase
General Anesthesia	Procedure: Pressure controlled ventilation with PEEP Procedure: Manual ventilation without PEEP	N/A

Detailed Description

Using a continuous positive pressure (CPAP) during preoxygenation, followed by pressure controlled ventilation with PEEP after apnoea during induction of general anesthesia, might offer several benefits but safety issues needs more investigation. This study compares the safety of using pressure controlled with PEEP during induction of general anesthesia immediately after apnoea to a standard method starting ventilation manually without PEEP immediately after apnoea.

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Safe Use of CPAP During Preoxygenation and PEEP After Apnoea During Induction of General Anesthesia

Actual Study Start Date :

Oct 19, 2021

Actual Primary Completion Date :

Dec 20, 2021

Actual Study Completion Date :

Dec 21, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pressure controlled ventilation with PEEP In this group, ventilation after apnoea during induction of general anesthesia starts with pressure controlled ventilation with PEEP.	Procedure: Pressure controlled ventilation with PEEP The intervention consists of starting ventilation after apnoea during induction of general anesthesia with pressure controlled ventilation with PEEP instead of manually without PEEP.
Active Comparator: Manual ventilation without PEEP In this group, ventilation after apnoea during induction of general anesthesia starts with manual ventilation without PEEP.	Procedure: Manual ventilation without PEEP The intervention consists of starting ventilation after apnoea during induction of general anesthesia manually instead of with pressure controlled ventilation with PEEP.

Arm

Intervention/Treatment

Experimental: Pressure controlled ventilation with PEEP

In this group, ventilation after apnoea during induction of general anesthesia starts with pressure controlled ventilation with PEEP.

Procedure: Pressure controlled ventilation with PEEP

The intervention consists of starting ventilation after apnoea during induction of general anesthesia with pressure controlled ventilation with PEEP instead of manually without PEEP.

Active Comparator: Manual ventilation without PEEP

In this group, ventilation after apnoea during induction of general anesthesia starts with manual ventilation without PEEP.

Procedure: Manual ventilation without PEEP

The intervention consists of starting ventilation after apnoea during induction of general anesthesia manually instead of with pressure controlled ventilation with PEEP.

Outcome Measures

Primary Outcome Measures

Number of breaths until return of CO2. [2 minutes]
When starting ventilation after apnea the number of breaths given until the return of CO2 is at least 1.2% at a respiratory frequency of 10 per minute.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Normal or overweight patients scheduled for day case surgery in general anesthesia.
American Society of Anesthesiologists functional class I-III.
Body Mass Index 18.5-30.

Exclusion Criteria:

Increased risk of regurgitation of gastric content.
Symptomatic asthma, COPD or heart failure.
Peripheral oxygen saturation (SpO2) breathing air <94 %
Anticipated difficult airway.
Beard.
Anatomical features making it difficult to keep a tight seal during maskventilation.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lennart Edmark	Västerås		Sweden	72241

Sponsors and Collaborators

Region Västmanland

Investigators

Principal Investigator: Lennart Edmark, PhD, Region Västmanland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lennart Edmark, Consultant, Principal Investigator, Region Västmanland

ClinicalTrials.gov Identifier:

NCT04271683

Other Study ID Numbers:

EPM 2019-05092

First Posted:

Feb 17, 2020

Last Update Posted:

Dec 22, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Lennart Edmark, Consultant, Principal Investigator, Region Västmanland

Positive end-expiratory pressure

Mechanical ventilation

Induction of anesthesia

Study Results

No Results Posted as of Dec 22, 2021