CPAP/PSV Preoxygenation in Obese Patients

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01780571
• Other study ID #: KIDS CPAP
• Status: Completed
• Phase: N/A
• First received: December 9, 2012
• Last updated: January 29, 2013
• Start date: May 2009
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anaesthesia
• Obesity

Intervention

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)

Locations

Country	Name	City	State
Sweden	Department of Anesthesiology and Intensive Care Danderyd Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post intubation PaO2levels	PaO2 levels is measured within 5 minutes after the completion of intubation.	5 minutes after intubation	Yes