The Effect of Postoperative Incentive Spirometry on Pulmonary Function and Pulmonary Complications in Bariatric Surgery

• Sponsor: Lahey Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT02431455
• Collaborator: (none)
• Enrollment: 224
• Location: 1
• Arms: 2
• Duration (Months): 11
• Patients Per Site Per Month: 20.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity, Morbid; Complications of Bariatric Procedures; Pulmonary Atelectasis; Pneumonia	Device: Incentive spirometer; Device: No incentive spirometer	N/A

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

• Study Type: Interventional
• Actual Enrollment: 224 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effect of Postoperative Incentive Spirometry on Pulmonary Function and Pulmonary Complications in Bariatric Surgery
• Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Incentive Spirometry Incentive spirometry 10 times per hour while awake	Device: Incentive spirometer; Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm.; Other Names: Control
Experimental: No Incentive Spirometry No incentive spirometer provided	Device: No incentive spirometer; No incentive spirometer is provided to the patient, this is the study arm.; Other Names: Study

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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 Outcome Measures

1. Postoperative Respiratory Complication [entire inpatient say, usually 1 to 7 days]

   atelectasis found on chest imaging, pneumonia, or re intubation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lahey Hospital & Medical Center	Burlington	Massachusetts	United States	01805

Sponsors and Collaborators

• Lahey Clinic

Investigators

• Principal Investigator: Dmitry Nepomnayshy, MD, Lahey Clinic General Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dmitry Nepomnayshy, Assistant Professor of Surgery TUFTS Medical School, Lahey Clinic
• ClinicalTrials.gov Identifier: NCT02431455
• Other Study ID Numbers: 2015-019
• First Posted: May 1, 2015
• Last Update Posted: Aug 25, 2016
• Last Verified: Jul 1, 2016

• Keywords provided by Dmitry Nepomnayshy, Assistant Professor of Surgery TUFTS Medical School, Lahey Clinic: Bariatric Surgery; obesity, morbid; incentive spirometry
• Additional relevant MeSH terms: Pulmonary Atelectasis; Obesity, Morbid

Study Results

Participant Flow

Arm/Group Title	Incentive Spirometry	No Incentive Spirometry
Arm/Group Description	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.	No incentive spirometer provided No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm.
Period Title: Overall Study
STARTED	112	112
COMPLETED	112	112
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Incentive Spirometry	No Incentive Spirometry	Total
Arm/Group Description	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.	No incentive spirometer provided No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm.	Total of all reporting groups
Overall Participants	112	112	224
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.2 (12.4)	45.9 (11.1)	45.6 (11.7)
Sex: Female, Male (Count of Participants)
Female	88 78.6%	86 76.8%	174 77.7%
Male	24 21.4%	26 23.2%	50 22.3%

Outcome Measures

1. Primary Outcome

Title	Hypoxia 6 Hours Postoperative
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Incentive Spirometry	No Incentive Spirometry
Arm/Group Description	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.	No incentive spirometer provided No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm.
Measure Participants	112	112
Number [participants]	13 11.6%	11 9.8%

2. Primary Outcome

Title	Hypoxia 12 Hours Postoperative
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Incentive Spirometry	No Incentive Spirometry
Arm/Group Description	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.	No incentive spirometer provided No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm.
Measure Participants	112	112
Number [participants]	6 5.4%	9 8%

3. Primary Outcome

Title	Hypoxia 24 Hours Postoperative
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Incentive Spirometry	No Incentive Spirometry
Arm/Group Description	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.	No incentive spirometer provided No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm.
Measure Participants	112	112
Number [participants]	4 3.6%	5 4.5%

4. Secondary Outcome

Title	Postoperative Respiratory Complication
Description	atelectasis found on chest imaging, pneumonia, or re intubation
Time Frame	entire inpatient say, usually 1 to 7 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Incentive Spirometry	No Incentive Spirometry
Arm/Group Description	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.	No incentive spirometer provided No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm.
Measure Participants	112	112
Number [participants]	8 7.1%	4 3.6%

Adverse Events

Arm/Group Title	Incentive Spirometry		No Incentive Spirometry
Arm/Group Description	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.		No incentive spirometer provided No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm.
All Cause Mortality
	Incentive Spirometry		No Incentive Spirometry
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Incentive Spirometry		No Incentive Spirometry
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/112 (0%)		0/112 (0%)
Other (Not Including Serious) Adverse Events
	Incentive Spirometry		No Incentive Spirometry
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/112 (0%)		0/112 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.