Bariatric Surgery, Lung Function
Conditions
Keywords
incentive spirometry, bariatric surgery, obesity
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.
Interventions
PROCEDUREIncentive Spirometry
helps patient monitor their inspiratory tidal volume and assists in the preventing lower airway collapse
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post Operative Incentive Spirometry Volume | 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
| Measure | Time frame |
|---|---|
| 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 |
| Level of Compliance | 3 days to 2 weeks after clinic visit on the day of surgery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| 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. | 20 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 4 | 5 |
Baseline characteristics
| Characteristic | Experimental Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 19 Participants | 37 Participants |
| Age, Continuous | 45.2 years STANDARD_DEVIATION 12.3 | 45.0 years STANDARD_DEVIATION 12.4 | 45.1 years STANDARD_DEVIATION 12.2 |
| Region of Enrollment United States | 20 participants | 21 participants | 41 participants |
| Sex: Female, Male Female | 18 Participants | 18 Participants | 36 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 20 |
| serious Total, serious adverse events | 0 / 21 | 0 / 20 |
Outcome results
Primary
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.
Time frame: 1 week before surgery to the day after
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Post Operative Incentive Spirometry Volume | 1557.9 cc | Standard Deviation 814.67 |
| Experimental Group | Post Operative Incentive Spirometry Volume | 1458.33 cc | Standard Deviation 613.87 |
Secondary
Heart Rate
Time frame: one week prior to surgery to post operative day 1
Secondary
Level of Compliance
Time frame: 3 days to 2 weeks after clinic visit on the day of surgery
Secondary
Oxygen Saturation
Time frame: one week prior to surgery up to one day after
Secondary
Respiratory Rate
Time frame: one week prior to surgery to post operative day 1