Pre-op Use of Incentive Spirometry in Obese Patients

Bariatric Surgery Clinical Trial

— IS  

Official title:

A Study on the Preoperative Use of Incentive Spirometry in Morbidly Obese Patients Undergoing General Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01004146
• Other study ID #: HSC-MS-08-0622
• Status: Completed
• Phase: N/A
• First received: March 30, 2009
• Last updated: December 13, 2013
• Start date: March 2009
• Est. completion date: September 2010

Study information

• Verified date: December 2013
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Bariatric Surgery
• Lung Function

Intervention

Procedure:
• Incentive Spirometry
helps patient monitor their inspiratory tidal volume and assists in the preventing lower airway collapse

Locations

Country	Name	City	State
United States	Memorial Hermann Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post Operative Incentive Spirometry Volume	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.	1 week before surgery to the day after	No
Secondary	Level of Compliance		3 days to 2 weeks after clinic visit on the day of surgery	No
Secondary	Oxygen Saturation		one week prior to surgery up to one day after	No
Secondary	Heart Rate		one week prior to surgery to post operative day 1	No
Secondary	Respiratory Rate		one week prior to surgery to post operative day 1	No