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Completed

NCT Number: NCT02431455

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

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.

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Key information

Conditions

Obesity, Morbid Body Weight Complications of Bariatric Procedures Infections Lung Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pneumonia Pulmonary Atelectasis Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lahey Hospital & Medical Center

Burlington, Massachusetts, 01805, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Incentive spirometer

Device

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

Other names: Control

No incentive spirometer

Device

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

Other names: Study

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Postoperative Respiratory Complication

    Time frame: entire inpatient say, usually 1 to 7 days

    atelectasis found on chest imaging, pneumonia, or re intubation

Sponsors and collaborators

Lead sponsor

Lahey Clinic

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 1, 2015
Registry last updated
Aug 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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