Pre-op Use of Incentive Spirometry in Obese Patients

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.

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

Conditions
-----------------
Lung Function, Bariatric Surgery

Intervention / Treatment
-----------------
* Procedure: Incentive Spirometry


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>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<br>* helps patient monitor their inspiratory tidal volume and assists in the preventing lower airway collapse<br>|
| Experimental: Experimental Group<br>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<br>* helps patient monitor their inspiratory tidal volume and assists in the preventing lower airway collapse<br>|

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 | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
incentive spirometry, bariatric surgery, obesity