Pre-op Use of Incentive Spirometry in Obese Patients

Not Applicable

Completed

• Conditions: Lung Function; Bariatric Surgery
• Interventions: Procedure: Incentive Spirometry

• Registration Number: NCT01004146
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-30
• Study First Submitted QC: 2009-10-28
• Study First Posted: 2009-10-29
• Primary Completion: 2009-12
• Study Completion: 2010-09
• Results First Submitted: 2013-06-17
• Status Verified: 2013-12
• Results First Submitted QC: 2013-12-13
• Last Update Submitted: 2013-12-13
• Results First Posted: 2014-02-03
• Last Update Posted: 2014-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Incentive Spirometry	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.
Control group	Incentive Spirometry	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.

Primary Outcome Measures

Name	Time	Method
Post Operative Incentive Spirometry Volume	1 week before surgery to the day after	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

Name	Time	Method
Level of Compliance	3 days to 2 weeks after clinic visit on the day of surgery
Oxygen Saturation	one week prior to surgery up to one day after
Heart Rate	one week prior to surgery to post operative day 1
Respiratory Rate	one week prior to surgery to post operative day 1

Trial Locations

Locations (1)

Memorial Hermann Hospital; 🇺🇸 Houston, Texas, United States