Airway Effects of PEEP During Anesthesia Induction.

September 30, 2016 updated by: Region Örebro County
This study investigates airway effects of PEEP during maskventilation at anesthesia induction. Four patient groups will be ventilated with different PEEP and driving pressures to evaluate time to open airway after start of positive pressure maskventilation during anesthesia induction.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The use of continuous positive pressure (CPAP/PEEP) during pre-oxygenation and mask-ventilation in patients undergoing anesthesia induction is increasing. Continuous positive pressures have several respiratory benefits with well-documented data on both spontaneously breathing patients and intubated patients. However the effects of PEEP on anesthetized patients during mask-ventilation is poorly investigated. In a previous trial the that the investigators conducted, a PEEP-level of 10 cmH2O during mask ventilation after anesthesia induction surprisingly delayed time to alveolar ventilation compared to ZEEP. In order to investigate this phenomenon, four groups of patients will be compared during preoxygenation and mask ventilation after anesthesia induction.

Each group consisting of 30 patients will be pre-oxygenated and mask ventilated with different CPAP/PEEP levels and different driving pressures. Time to open airway is measured as number of respiratory cycles until detection of CO2 on the capnograph.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. ≥ 18- ≤ 65 years male or female.
  2. Elective surgery under general anesthesia
  3. ASA-classification 1-3
  4. Signed and dated informed consent

Exclusion Criteria:

  1. BMI > 30
  2. Predicted difficult mask-ventilation
  3. Known hiatus hernia or GERD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 0 CPAP/ 0 PEEP, driving pressure 10
Patients will be preoxygenated with a CPAP-level of 0 cmH2O and after anesthesia induction, mask-ventilated with ZEEP and a driving pressure of 10 cmH2O./PEEP-level, driving pressure
Procedure: PEEP-level, driving pressure
Different levels of PEEP and different levels of driving pressures during mask-ventilation at anesthesia induction.
Other: 0 CPAP/ 0 PEEP driving pressure 20
Patients will be pre-oxygenated with a CPAP-level of 0 cmH2O and after anesthesia induction, mask-ventilated with ZEEP and a driving pressure of 20 cmH2O./PEEP-level, driving pressure
Procedure: PEEP-level, driving pressure
Different levels of PEEP and different levels of driving pressures during mask-ventilation at anesthesia induction.
Other: 10 CPAP / 10 PEEP, driving pressure 10
Patients will be pre-oxygenated with a CPAP-level of 10 cmH2O and after anesthesia induction, mask-ventilated with PEEP 10 cmH2O and a driving pressure of 10 cmH2O./PEEP-level, driving pressure
Procedure: PEEP-level, driving pressure
Different levels of PEEP and different levels of driving pressures during mask-ventilation at anesthesia induction.
Other: 10 CPAP/ 0 PEEP, driving pressure 10
Patients will be pre-oxygenated with a CPAP-level of 10 cmH2O and after anesthesia induction, mask-ventilated with ZEEP and a driving pressure of 10 cmH2O./PEEP-level, driving pressure
Procedure: PEEP-level, driving pressure
Different levels of PEEP and different levels of driving pressures during mask-ventilation at anesthesia induction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to open airway
Time Frame: 20 minutes
Time to open airway depending on ventilatory settings
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Örebro County

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

February 1, 2017

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

September 28, 2016

First Submitted That Met QC Criteria

September 28, 2016

First Posted (Estimate)

September 30, 2016

Study Record Updates

Last Update Posted (Estimate)

October 3, 2016

Last Update Submitted That Met QC Criteria

September 30, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • PC02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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