NCT02431455

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 1, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
4 months until next milestone

Results Posted

Study results publicly available

August 25, 2016

Completed
Last Updated

August 25, 2016

Status Verified

July 1, 2016

Enrollment Period

11 months

First QC Date

April 1, 2015

Results QC Date

April 4, 2016

Last Update Submit

July 15, 2016

Conditions

Obesity, MorbidComplications of Bariatric ProceduresPulmonary AtelectasisPneumonia

Keywords

Bariatric Surgeryobesity, morbidincentive spirometry

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (1)

  • Postoperative Respiratory Complication

    entire inpatient say, usually 1 to 7 days

Study Arms (2)

Incentive Spirometry

ACTIVE COMPARATOR

Incentive spirometry 10 times per hour while awake

Device: Incentive spirometer

No Incentive Spirometry

EXPERIMENTAL

No incentive spirometer provided

Device: No incentive spirometer

Interventions

Incentive spirometerDEVICE

Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm.

Also known as: Control
Incentive Spirometry
No incentive spirometerDEVICE

No incentive spirometer is provided to the patient, this is the study arm.

Also known as: Study
No Incentive Spirometry

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients medically cleared to undergo bariatric surgery per the usual screening process

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lahey Hospital & Medical Center

Burlington, Massachusetts, 01805, United States

Location

Related Publications (1)

  • 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.

    PMID: 28097332DERIVED

MeSH Terms

Conditions

Obesity, MorbidPulmonary AtelectasisPneumonia

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsLung DiseasesRespiratory Tract DiseasesRespiratory Tract InfectionsInfections

Results Point of Contact

Title
Haddon Pantel
Organization
Lahey Hospital and Medical Center
Haddon.Pantel@Lahey.org
3013566674

Study Officials

  • Dmitry Nepomnayshy, MD

    Lahey Clinic General Surgery

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Surgery TUFTS Medical School

Study Record Dates

First Submitted

April 1, 2015

First Posted

May 1, 2015

Study Start

June 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

August 25, 2016

Results First Posted

August 25, 2016

Record last verified: 2016-07

Locations

US(1)