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Pre-op Use of Incentive Spirometry in Obese Patients (IS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Davide Cattano, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01004146
First received: March 30, 2009
Last updated: March 1, 2012
Last verified: March 2012
History of Changes

March 30, 2009
March 1, 2012
March 2009
December 2009   (final data collection date for primary outcome measure)
incentive spirometry volume [ Time Frame: 1 week before surgery to the day after ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01004146 on ClinicalTrials.gov Archive Site
  • level of compliance [ Time Frame: 3 days to 2 weeks after clinic visit on the day of surgery ] [ Designated as safety issue: No ]
  • oxygen saturation [ Time Frame: one week prior to surgery up to one day after ] [ Designated as safety issue: No ]
  • heart rate [ Time Frame: one week prior to surgery to post operative day 1 ] [ Designated as safety issue: No ]
  • respiratory rate [ Time Frame: one week prior to surgery to post operative day 1 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pre-op Use of Incentive Spirometry in Obese Patients
A Study on the Preoperative Use of Incentive Spirometry in Morbidly Obese Patients Undergoing General Anesthesia

The purpose of this study is to evaluate the use of preoperative incentive spirometry (IS) as an aid to improve postoperative lung function. The hypothesis is that application of a standardized protocol of preoperative respiratory care teaching and exercise will improve lung performance that will subsequently result in prevention of postoperative pulmonary complications and that increasing the duration of preoperative use better improves lung mechanics postoperatively. The investigators propose to compare a patient population that uses IS as currently prescribed in the routine course of care (only to be familiar with preoperatively, but use postoperatively) against a population that uses IS with a standardized regimen for at least 3 days prior to the operation in terms of preoperative IS volumes, intraoperative pulmonary mechanics, postoperative IS volumes, and incidence of postoperative pulmonary complications.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Lung Function
  • Bariatric Surgery
Device: Incentive Spirometry
helps patient monitor their inspiratory tidal volume and assists in the preventing lower airway collapse
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
September 2010
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • morbid obesity
  • bariatric surgery
  • must be able to use incentive spirometer

Exclusion Criteria:

  • BMI=<40 kg/m2
  • current symptoms of obstructive sleep apnea or actively using CPAP
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01004146
HSC-MS-08-0622
Yes
Davide Cattano, The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
Not Provided
Principal Investigator: Davide Cattano, M.D. University of Texas Medical School
The University of Texas Health Science Center, Houston
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP