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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Incentive Spirometry | Active Comparator | Incentive spirometry 10 times per hour while awake |
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| No Incentive Spirometry | Experimental | No incentive spirometer provided |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Incentive spirometer | Device | Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 hours postoperative |
| 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. | 12 hours postoperative |
| 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. | 24 hours postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Respiratory Complication | atelectasis found on chest imaging, pneumonia, or re intubation | entire inpatient say, usually 1 to 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dmitry Nepomnayshy, MD | Lahey Clinic General Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lahey Hospital & Medical Center | Burlington | Massachusetts | 01805 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28097332 | Derived | Pantel H, Hwang J, Brams D, Schnelldorfer T, Nepomnayshy D. Effect of Incentive Spirometry on Postoperative Hypoxemia and Pulmonary Complications After Bariatric Surgery: A Randomized Clinical Trial. JAMA Surg. 2017 May 1;152(5):422-428. doi: 10.1001/jamasurg.2016.4981. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | No Incentive Spirometry |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| No incentive spirometer | Device | No incentive spirometer is provided to the patient, this is the study arm. |
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No incentive spirometer provided No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | No Incentive Spirometry | No incentive spirometer provided No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants | 6 hours postoperative |
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| 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. | Posted | Number | participants | 12 hours postoperative |
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| 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. | Posted | Number | participants | 24 hours postoperative |
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| Secondary | Postoperative Respiratory Complication | atelectasis found on chest imaging, pneumonia, or re intubation | Posted | Number | participants | entire inpatient say, usually 1 to 7 days |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 112 | 0 | 112 | ||
| EG001 | No Incentive Spirometry | No incentive spirometer provided No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm. | 0 | 112 | 0 | 112 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Haddon Pantel | Lahey Hospital and Medical Center | 3013566674 | Haddon.Pantel@Lahey.org |
| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D001261 | Pulmonary Atelectasis |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Male |
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