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NCT04271683 Clinical Trial

Safe Use of CPAP and PEEP During Induction of General Anesthesia

General Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04271683
Other study ID # EPM 2019-05092
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 19, 2021
Est. completion date December 21, 2021

Study information
Verified date May 2023
Source Region Västmanland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date December 21, 2021
Est. primary completion date December 20, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.
• 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.

Locations
Country Name City State
Sweden Lennart Edmark Västerås

Sponsors (1)
Lead Sponsor Collaborator
Region Västmanland

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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