Obesity, MorbidNCT02431455
The Effect of Postoperative Incentive Spirometry on Pulmonary Function and Pulmonary Complications in Bariatric Surgery
A study testing Incentive spirometer and No incentive spirometer in people with Obesity, Morbid and Complications of Bariatric Procedures, run by Lahey Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Morbid, Complications of Bariatric Procedures, Pulmonary Atelectasis
- What is being tested?
- Incentive spirometer and No incentive spirometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients medically cleared to undergo bariatric surgery per the usual screening process
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805
About this study
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.
Read the 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.
- Being tested
- Incentive spirometer, No incentive spirometer
- Keywords
- Bariatric Surgery, obesity, morbid, incentive spirometry
- Medical subject headings
- Obesity, Morbid, Pulmonary Atelectasis, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incentive spirometerDevice
Also called Control
Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm.
No incentive spirometerDevice
Also called Study
No incentive spirometer is provided to the patient, this is the study arm.
| Study group | Role | What they receive |
|---|---|---|
| Incentive Spirometry | Active comparator | Incentive spirometry 10 times per hour while awake Receives: Device: Incentive spirometer |
| No Incentive Spirometry | Experimental | No incentive spirometer provided Receives: Device: No incentive spirometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 24 hours postoperative
Secondary outcomes (1)
Postoperative Respiratory Complication
atelectasis found on chest imaging, pneumonia, or re intubation
Measured: entire inpatient say, usually 1 to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2015 (estimated)
- Study startJun 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahey Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dmitry Nepomnayshy, Lahey Clinic
- Investigators
- Dmitry Nepomnayshy, MD, Principal investigator, Lahey Clinic General Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02431455
- Sponsor's protocol ID
- 2015-019
- Status last verified
- Jul 2016
- First submitted
- 1 Apr 2015
- Last updated
- 25 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 28097332
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Postoperative Incentive Spirometry on Pulmonary Function and Pulmonary Complications in Bariatric Surgery
- ClinicalTrials.gov ID
- NCT02431455
- Acronym / sponsor ID
- 2015-019
- Keywords
- Bariatric Surgery, obesity, morbid, incentive spirometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Lahey ClinicUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 1 May 2015 (estimated)
- Results
- Posted 25 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incentive Spirometry | Active comparator | Device: Incentive spirometerIncentive spirometry 10 times per hour while awake |
| No Incentive Spirometry | Experimental | Device: No incentive spirometerNo incentive spirometer provided |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients medically cleared to undergo bariatric surgery per the usual screening process
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incentive spirometerAlso: ControlIncentive spirometer is provided to the patient, this is the current standard of care, and is the control arm. | Device | Incentive Spirometry |
| No incentive spirometerAlso: StudyNo incentive spirometer is provided to the patient, this is the study arm. | Device | No Incentive Spirometry |
Primary outcome
Hypoxia 6 Hours Postoperative
Time frame: 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
Time frame: 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
Time frame: 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.
1 secondary outcome
Postoperative Respiratory Complication
Time frame: entire inpatient say, usually 1 to 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28097332Pantel 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.
Related trials for Obesity, Morbid
Active, not recruiting
Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
Bariatric Surgery Candidate, Obesity
Active, not recruiting
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Obesity, Morbid, Eating Disorder Symptom
RecruitingPhase 3
Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance
Obesity, Childhood, Insulin Resistance
RecruitingPhase 4
Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease
Liver Cirrhoses, Portal Hypertension Related to Cirrhosis
RecruitingPhase 3
A Study Evaluating Mibavademab Treatment of Obesity Due to Leptin (LEP) Gene Mutations in Children, Adolescents and Adults
Monogenic Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dmitry Nepomnayshy, MD principal investigator
Lahey Clinic General Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incentive spirometer and No incentive spirometer in people with Obesity, Morbid and Complications of Bariatric Procedures, run by Lahey Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoxia 6 Hours Postoperative (time frame: 6 hours postoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02431455, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2016.