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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
  Purpose

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.


Condition Intervention
Lung Function
Bariatric Surgery
 Device: Incentive Spirometry

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Study on the Preoperative Use of Incentive Spirometry in Morbidly Obese Patients Undergoing General Anesthesia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • incentive spirometry volume [ Time Frame: 1 week before surgery to the day after ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: March 2009
Study Completion Date: September 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Incentive Spirometry
    helps patient monitor their inspiratory tidal volume and assists in the preventing lower airway collapse
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01004146

Locations
United States, Texas
Memorial Hermann Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Davide Cattano, M.D. University of Texas Medical School
  More Information

No publications provided

Responsible Party: Davide Cattano, Associate Proffessor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01004146     History of Changes
Other Study ID Numbers: HSC-MS-08-0622
Study First Received: March 30, 2009
Last Updated: March 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
incentive spirometry
bariatric surgery
obesity

ClinicalTrials.gov processed this record on May 19, 2013