Trial Outcomes & Findings for Pre-op Use of Incentive Spirometry in Obese Patients (NCT NCT01004146)

Results Overview

After the operation, the patients to be discharged on the same day were approached in the postanesthesia care unit (PACU) and requested to use the spirometer again. The volume (best out of 2 attempts) was recorded together with the same vital signs recorded preoperatively. Patients who were admitted to the hospital were requested to use the spirometer again on postoperative day 1. The largest IS volume (out of 2 attempts) was recorded. The data presented is the mean largest IS volume the day after surgery.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

1 week before surgery to the day after

Results posted on

2014-02-03

Participant Flow

Participant milestones

Participant milestones
Measure	Control Group Patients assigned to the control group were educated on the proper technique of using the incentive spirometer to familiarize themselves with the device. Subjects were instructed to use it for 3 breaths once per day so that they would able to use the device properly and consistently. All patients in this group used the device at least 3 days prior to their surgical procedure.	Experimental Group Patients assigned to the experimental group were instructed to use the incentive spirometer by inhaling as slowly and deeply as possible in a set of 10 times and were asked to repeat the process at least 5 times every day until the day of surgery. All patients in this group used the device at least 3 days prior to their surgical procedure.
Overall Study STARTED	25	25
Overall Study Have Incentive Spirometry Data	21	20
Overall Study COMPLETED	21	20
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Group Patients assigned to the control group were educated on the proper technique of using the incentive spirometer to familiarize themselves with the device. Subjects were instructed to use it for 3 breaths once per day so that they would able to use the device properly and consistently. All patients in this group used the device at least 3 days prior to their surgical procedure.	Experimental Group Patients assigned to the experimental group were instructed to use the incentive spirometer by inhaling as slowly and deeply as possible in a set of 10 times and were asked to repeat the process at least 5 times every day until the day of surgery. All patients in this group used the device at least 3 days prior to their surgical procedure.
Overall Study Withdrawal by Subject	4	5

Baseline Characteristics

Pre-op Use of Incentive Spirometry in Obese Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group n=21 Participants Patients assigned to the control group were educated on the proper technique of using the incentive spirometer and were instructed to use it for 3 breaths once per day to become able to use the device properly and consistently.	Experimental Group n=20 Participants Patients assigned to the experimental group were instructed to use the spirometer by inhaling as slowly and deeply as possible in a set of 10 times and to repeat the process at least 5 times every day until the day of surgery.	Total n=41 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=93 Participants	18 Participants n=4 Participants	37 Participants n=27 Participants
Age, Categorical >=65 years	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Age, Continuous	45.0 years STANDARD_DEVIATION 12.4 • n=93 Participants	45.2 years STANDARD_DEVIATION 12.3 • n=4 Participants	45.1 years STANDARD_DEVIATION 12.2 • n=27 Participants
Sex: Female, Male Female	18 Participants n=93 Participants	18 Participants n=4 Participants	36 Participants n=27 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants
Region of Enrollment United States	21 participants n=93 Participants	20 participants n=4 Participants	41 participants n=27 Participants

PRIMARY outcome

Timeframe: 1 week before surgery to the day after

After the operation, the patients to be discharged on the same day were approached in the postanesthesia care unit (PACU) and requested to use the spirometer again. The volume (best out of 2 attempts) was recorded together with the same vital signs recorded preoperatively. Patients who were admitted to the hospital were requested to use the spirometer again on postoperative day 1. The largest IS volume (out of 2 attempts) was recorded. The data presented is the mean largest IS volume the day after surgery.

Outcome measures

Outcome measures
Measure	Control Group n=21 Participants Patients assigned to the control group were educated on the proper technique of using the incentive spirometer and were instructed to use it for 3 breaths once per day to become able to use the device properly and consistently.	Experimental Group n=20 Participants Patients assigned to the experimental group were instructed to use the spirometer by inhaling as slowly and deeply as possible in a set of 10 times and to repeat the process at least 5 times every day until the day of surgery.
Post Operative Incentive Spirometry Volume	1557.9 cc Standard Deviation 814.67	1458.33 cc Standard Deviation 613.87

SECONDARY outcome

Timeframe: 3 days to 2 weeks after clinic visit on the day of surgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one week prior to surgery up to one day after

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one week prior to surgery to post operative day 1

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one week prior to surgery to post operative day 1

Outcome measures

Outcome data not reported

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Experimental Group

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

Dr. Davide Cattano

University of Texas at Houston Medical School / Dept. of Anesthesiology

Phone: 713-500-6235

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place