Obesity, Morbid, Complications of Bariatric Procedures, Pulmonary Atelectasis, Pneumonia
Conditions
Keywords
Bariatric Surgery, obesity, morbid, incentive spirometry
Brief summary
This study evaluates the omission of incentive spirometry use following bariatric surgery. Half of participants will receive an incentive spirometer while the other half will not. Oxygen saturation and pulmonary complications after surgery will be measured to examine the effectiveness of incentive spirometry.
Detailed description
Incentive spirometry is speculated to improve pulmonary function in the postoperative period, though data to support this is lacking. Patients undergoing bariatric surgery are at increased risk for pulmonary compromise as they are obese and undergoing foregut surgery. This study aims to examine the effect of incentive spirometry after bariatric surgery by performing a prospective randomized trial. Subjects will be randomized to either receive an incentive spirometer or not. The primary outcome measure of oxygen saturation off of supplemental oxygen will be taken preoperatively and at 6,12, and 24 hours postoperatively. Secondary outcome measures include rate of pulmonary complications, and time to wean off of supplemental oxygen.
Interventions
DEVICEIncentive spirometer
Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm.
DEVICENo incentive spirometer
No incentive spirometer is provided to the patient, this is the study arm.
Sponsors
Lahey Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients medically cleared to undergo bariatric surgery per the usual screening process
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypoxia 6 Hours Postoperative | 6 hours postoperative | Number of subjects with pulse oximetry reading of \< 92% with subject off of supplemental oxygen for 5 minutes with head of bed at 30°, 6 hours postoperative. |
| Hypoxia 12 Hours Postoperative | 12 hours postoperative | Number of subjects with pulse oximetry reading of \< 92% with subject off of supplemental oxygen for 5 minutes with head of bed at 30°, 12 hours postoperative. |
| Hypoxia 24 Hours Postoperative | 24 hours postoperative | Number of subjects with pulse oximetry reading of \< 92% with subject off of supplemental oxygen for 5 minutes with head of bed at 30°, 24 hours postoperative. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Respiratory Complication | entire inpatient say, usually 1 to 7 days | atelectasis found on chest imaging, pneumonia, or re intubation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Incentive Spirometry Incentive spirometry 10 times per hour while awake
Incentive spirometer: Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm. | 112 |
| No Incentive Spirometry No incentive spirometer provided
No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm. | 112 |
| Total | 224 |
Baseline characteristics
| Characteristic | Incentive Spirometry | No Incentive Spirometry | Total |
|---|---|---|---|
| Age, Continuous | 45.2 years STANDARD_DEVIATION 12.4 | 45.9 years STANDARD_DEVIATION 11.1 | 45.6 years STANDARD_DEVIATION 11.7 |
| Sex: Female, Male Female | 88 Participants | 86 Participants | 174 Participants |
| Sex: Female, Male Male | 24 Participants | 26 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 112 | 0 / 112 |
| serious Total, serious adverse events | 0 / 112 | 0 / 112 |
Outcome results
Primary
Hypoxia 12 Hours Postoperative
Number of subjects with pulse oximetry reading of \< 92% with subject off of supplemental oxygen for 5 minutes with head of bed at 30°, 12 hours postoperative.
Time frame: 12 hours postoperative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Incentive Spirometry | Hypoxia 12 Hours Postoperative | 6 participants |
| No Incentive Spirometry | Hypoxia 12 Hours Postoperative | 9 participants |
Primary
Hypoxia 24 Hours Postoperative
Number of subjects with pulse oximetry reading of \< 92% with subject off of supplemental oxygen for 5 minutes with head of bed at 30°, 24 hours postoperative.
Time frame: 24 hours postoperative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Incentive Spirometry | Hypoxia 24 Hours Postoperative | 4 participants |
| No Incentive Spirometry | Hypoxia 24 Hours Postoperative | 5 participants |
Primary
Hypoxia 6 Hours Postoperative
Number of subjects with pulse oximetry reading of \< 92% with subject off of supplemental oxygen for 5 minutes with head of bed at 30°, 6 hours postoperative.
Time frame: 6 hours postoperative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Incentive Spirometry | Hypoxia 6 Hours Postoperative | 13 participants |
| No Incentive Spirometry | Hypoxia 6 Hours Postoperative | 11 participants |
Secondary
Postoperative Respiratory Complication
atelectasis found on chest imaging, pneumonia, or re intubation
Time frame: entire inpatient say, usually 1 to 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Incentive Spirometry | Postoperative Respiratory Complication | 8 participants |
| No Incentive Spirometry | Postoperative Respiratory Complication | 4 participants |