CPAP/PSV Preoxygenation in Obese Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Erik Näslund, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01780571
First received: December 9, 2012
Last updated: January 29, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Obesity
Anaesthesia
Procedure: CPAP 5 cm H2O + PSV 5 cm H2O

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Continuous Positive Airway Pressure/Pressure Support Preoxygenation of Morbidly Obese Patients

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Post intubation PaO2levels [ Time Frame: 5 minutes after intubation ] [ Designated as safety issue: Yes ]
    PaO2 levels is measured within 5 minutes after the completion of intubation.


Enrollment: 44
Study Start Date: May 2009
Study Completion Date: December 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01780571

Locations
Sweden
Department of Anesthesiology and Intensive Care Danderyd Hospital
Stockholm, Sweden, 18288
Sponsors and Collaborators
Karolinska Institutet
  More Information

No publications provided

Responsible Party: Erik Näslund, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01780571     History of Changes
Other Study ID Numbers: KIDS CPAP
Study First Received: December 9, 2012
Last Updated: January 29, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:
Obesity
general anaesthesia
preoxygenation
atelectasis

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014