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Completed

NCT Number: NCT04271683

Safe Use of CPAP and PEEP 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.

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Key information

Conditions

General Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lennart Edmark

Västerås, 72241, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Number of breaths until return of CO2.

    Time frame: 2 minutes

    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.

Sponsors and collaborators

Lead sponsor

Region Västmanland

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 17, 2020
Registry last updated
May 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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