N/A
N=50
Pre-op Use of Incentive Spirometry in Obese Patients
Lung Function · Bariatric Surgery
Bottom Line
View on ClinicalTrials.gov: NCT01004146 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Post Operative Incentive Spirometry Volume — 1557.9; 1458.33 cc
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Incentive Spirometry (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post Operative Incentive Spirometry Volume |
1557.9; 1458.33 | — |
| SECONDARY Level of Compliance |
— | — |
| SECONDARY Oxygen Saturation |
— | — |
| SECONDARY Heart Rate |
— | — |
| SECONDARY Respiratory Rate |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01004146). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.