Pre-op Use of Incentive Spirometry in Obese Patients

NCT ID: NCT01004146

Last Updated: 2014-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2010-09-30

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.

Conditions

Lung Function; Bariatric Surgery

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Incentive Spirometry

Intervention Type: PROCEDURE

helps patient monitor their inspiratory tidal volume and assists in the preventing lower airway collapse

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.

Group Type: EXPERIMENTAL

Incentive Spirometry

Intervention Type: PROCEDURE

helps patient monitor their inspiratory tidal volume and assists in the preventing lower airway collapse

Interventions

Incentive Spirometry

helps patient monitor their inspiratory tidal volume and assists in the preventing lower airway collapse

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Davide Cattano

Associate Proffessor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Davide Cattano, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Texas Medical School

Locations

Memorial Hermann Hospital

Houston, Texas, United States

Countries

United States

Other Identifiers

HSC-MS-08-0622

Identifier Type: -

Identifier Source: org_study_id