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: December 13, 2013
Last verified: December 2013
  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
Procedure: 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:


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

Primary Outcome Measures:
  • Post Operative Incentive Spirometry Volume [ Time Frame: 1 week before surgery to the day after ] [ Designated as safety issue: No ]
    After the operation, the patients to be discharged on the same day were approached in the postanesthesia care unit (PACU) and requested to use the spirometer again. The volume (best out of 2 attempts) was recorded together with the same vital signs recorded preoperatively. Patients who were admitted to the hospital were requested to use the spirometer again on postoperative day 1. The largest IS volume (out of 2 attempts) was recorded. The data presented is the mean largest IS volume the day after surgery.


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)
Arms Assigned Interventions
Placebo Comparator: Control group
Patients assigned to the control group were educated on the proper technique of using the incentive spirometer and were instructed to use it for 3 breaths once per day to become able to use the device properly and consistently.
Procedure: Incentive Spirometry
helps patient monitor their inspiratory tidal volume and assists in the preventing lower airway collapse
Experimental: Experimental Group
Patients assigned to the experimental group were instructed to use the spirometer by inhaling as slowly and deeply as possible in a set of 10 times and to repeat the process at least 5 times every day until the day of surgery.
Procedure: 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 continuous positive airway pressure
  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: 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
Results First Received: June 17, 2013
Last Updated: December 13, 2013
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 October 21, 2014