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Clinical Trials/NCT01004146
NCT01004146CompletedNot Applicable

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

The University of Texas Health Science Center, Houston2 sites in 1 country50 target enrollmentStarted: March 1, 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
2
Primary Endpoint
Post Operative Incentive Spirometry Volume

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Post Operative Incentive Spirometry Volume

Time Frame: 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 Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Davide Cattano

Associate Proffessor

The University of Texas Health Science Center, Houston

Study Sites (2)

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