Trial Outcomes & Findings for The Effect of Postoperative Incentive Spirometry on Pulmonary Function and Pulmonary Complications in Bariatric Surgery (NCT NCT02431455)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

224 participants

Primary outcome timeframe

6 hours postoperative

Results posted on

2016-08-25

Participant Flow

Participant milestones

Participant milestones
Measure	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.	No Incentive Spirometry No incentive spirometer provided No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm.
Overall Study STARTED	112	112
Overall Study COMPLETED	112	112
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Incentive Spirometry n=112 Participants 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 Spirometry n=112 Participants No incentive spirometer provided No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm.	Total n=224 Participants Total of all reporting groups
Age, Continuous	45.2 years STANDARD_DEVIATION 12.4 • n=99 Participants	45.9 years STANDARD_DEVIATION 11.1 • n=107 Participants	45.6 years STANDARD_DEVIATION 11.7 • n=206 Participants
Sex: Female, Male Female	88 Participants n=99 Participants	86 Participants n=107 Participants	174 Participants n=206 Participants
Sex: Female, Male Male	24 Participants n=99 Participants	26 Participants n=107 Participants	50 Participants n=206 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Incentive Spirometry n=112 Participants 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 Spirometry n=112 Participants No incentive spirometer provided No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm.
Hypoxia 6 Hours Postoperative	13 participants	11 participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Incentive Spirometry n=112 Participants 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 Spirometry n=112 Participants No incentive spirometer provided No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm.
Hypoxia 12 Hours Postoperative	6 participants	9 participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Incentive Spirometry n=112 Participants 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 Spirometry n=112 Participants No incentive spirometer provided No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm.
Hypoxia 24 Hours Postoperative	4 participants	5 participants

SECONDARY outcome

Timeframe: entire inpatient say, usually 1 to 7 days

atelectasis found on chest imaging, pneumonia, or re intubation

Outcome measures

Outcome measures
Measure	Incentive Spirometry n=112 Participants 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 Spirometry n=112 Participants No incentive spirometer provided No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm.
Postoperative Respiratory Complication	8 participants	4 participants

Adverse Events

Incentive Spirometry

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Incentive Spirometry

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Haddon Pantel

Lahey Hospital and Medical Center

Phone: 3013566674

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place