CPAP/PSV Preoxygenation in Obese Patients

January 29, 2013 updated by: Erik Näslund, Karolinska Institutet

Continuous Positive Airway Pressure/Pressure Support Preoxygenation of Morbidly Obese Patients

The purpose of this study is to determine whether continuouse positive airway pressure (CPAP), during induction of anaesthesia in morbidly obese patients, result in higher levels of oxygen in the blood.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

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.

Study Locations

  • Sweden
      • Stockholm, Sweden, 18288
        • Department of Anesthesiology and Intensive Care Danderyd Hospital

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 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • body mass index (BMI) > 35 kg/m2
  • scheduled to undergo elective gastric bypass surgery
  • age ≥ 18 years
  • ASA Physical Status Classification II-III

Exclusion Criteria:

  • significant cardiopulmonary disease
  • previous abdominal or thoracic surgery
  • inability to comprehend the protocol.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Neutral pressure breathing after 2 min preoxygenation
Active Comparator: Active group
CPAP 5cm H2O + PSV 5cm H2O breathing after 2 min preoxygenation
Procedure: CPAP 5 cm H2O + PSV 5 cm H2O
Patients in the intervention group received Continuous Positive Airway Pressure (5 cm H2O) and Pressure Supported Ventilation (5 cm H2O)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post intubation PaO2levels
Time Frame: 5 minutes after intubation
PaO2 levels is measured within 5 minutes after the completion of intubation.
5 minutes after intubation

Collaborators and Investigators

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

Sponsor

Karolinska Institutet

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

May 1, 2009

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

December 9, 2012

First Submitted That Met QC Criteria

January 29, 2013

First Posted (Estimate)

January 31, 2013

Study Record Updates

Last Update Posted (Estimate)

January 31, 2013

Last Update Submitted That Met QC Criteria

January 29, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KIDS CPAP

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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