Pre-op Use of Incentive Spirometry in Obese Patients (IS)

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

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.

Study Overview

• Status: Completed
• Conditions: Bariatric Surgery; Lung Function
• Intervention / Treatment: Procedure: Incentive Spirometry

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Memorial Hermann Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Davide Cattano, M.D., University of Texas Medical School

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: March 30, 2009
• First Submitted That Met QC Criteria: October 28, 2009
• First Posted (Estimate): October 29, 2009

Study Record Updates

• Last Update Posted (Estimate): February 3, 2014
• Last Update Submitted That Met QC Criteria: December 13, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: obesity; bariatric surgery; incentive spirometry
• Other Study ID Numbers: HSC-MS-08-0622