Safe Use of CPAP and PEEP During Induction of General Anesthesia

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

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.

Study Overview

• Status: Completed
• Conditions: General Anesthesia
• Intervention / Treatment: Procedure: Pressure controlled ventilation with PEEP; Procedure: Manual ventilation without PEEP

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Västerås, Sweden, 72241
    • Lennart Edmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of breaths until return of CO2.	When starting ventilation after apnea the number of breaths given until the return of CO2 is at least 1.3 kPa at a respiratory frequency of 10 per minute.	2 minutes

Collaborators and Investigators

• Sponsor: Region Västmanland

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2021
• Primary Completion (Actual): December 20, 2021
• Study Completion (Actual): December 21, 2021

Study Registration Dates

• First Submitted: February 13, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): May 8, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Mechanical ventilation; Positive end-expiratory pressure; Induction of anesthesia
• Other Study ID Numbers: EPM 2019-05092

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Please email request to the study principal investigator.
• IPD Sharing Time Frame: Data will be available after publication of study results, approximately 18 months after study completion.

IPD Sharing Access Criteria

Data access requests will be reviewed by a review panel at the Center for Clinical Research, Västerås.

Requestors will be required to sign a data access agreement.

.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No