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Safe Use of CPAP and PEEP During Induction of General Anesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04271683
Recruitment Status : Not yet recruiting
First Posted : February 17, 2020
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Lennart Edmark, Region Västmanland

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : June 18, 2020
Estimated Study Completion Date : June 18, 2020

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.




Primary Outcome Measures :
  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 1.2% at a respiratory frequency of 10 per minute.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04271683


Contacts
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Contact: Lennart Edmark, PhD +46 21 173000 lennart.edmark@regionvastmanland.se

Sponsors and Collaborators
Region Västmanland
Investigators
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Principal Investigator: Lennart Edmark, PhD Region Västmanland

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Responsible Party: Lennart Edmark, Consultant, Principal Investigator, Region Västmanland
ClinicalTrials.gov Identifier: NCT04271683    
Other Study ID Numbers: EPM 2019-05092
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Please email request to the study principal investigator.
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lennart Edmark, Region Västmanland:
Positive end-expiratory pressure
Mechanical ventilation
Induction of anesthesia