Safe Use of CPAP and PEEP During Induction of General Anesthesia

NCT04271683 | Completed

• 1 other identifier: EPM 2019-05092
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

General Anesthesia

Keywords

Positive end-expiratory pressure; Mechanical ventilation; Induction of anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Pressure controlled ventilation with PEEP

EXPERIMENTAL

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

Procedure: Pressure controlled ventilation with PEEP

Manual ventilation without PEEP

ACTIVE COMPARATOR

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

Procedure: Manual ventilation without PEEP

Interventions

Pressure controlled ventilation with PEEP PROCEDURE

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

Pressure controlled ventilation with PEEP

Manual ventilation without PEEP PROCEDURE

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

Manual ventilation without PEEP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region Västmanland: lead

Study Sites (1)

Lennart Edmark

Västerås, 72241, Sweden

Location

MeSH Terms

Interventions

Positive-Pressure Respiration

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Lennart Edmark, PhD

  Region Västmanland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Principal Investigator

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 17, 2020
• Study Start: October 19, 2021
• Primary Completion: December 20, 2021
• Study Completion: December 21, 2021
• Last Updated: May 8, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available after publication of study results, approximately 18 months after study completion.
• 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. .

Locations

SE (1)