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Pre-op Use of Incentive Spirometry in Obese Patients (IS)

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ClinicalTrials.gov Identifier: NCT01004146
Recruitment Status : Completed
First Posted : October 29, 2009
Results First Posted : February 3, 2014
Last Update Posted : February 3, 2014
Sponsor:
Information provided by (Responsible Party):
Davide Cattano, The University of Texas Health Science Center, Houston

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Lung Function
Bariatric Surgery
Intervention Procedure: Incentive Spirometry
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Group Experimental Group
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 25 25
Have Incentive Spirometry Data 21 20
Completed 21 20
Not Completed 4 5
Reason Not Completed
Withdrawal by Subject             4             5
Arm/Group Title Control Group Experimental Group Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 21 20 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 20 participants 41 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
19
  90.5%
18
  90.0%
37
  90.2%
>=65 years
2
   9.5%
2
  10.0%
4
   9.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 20 participants 41 participants
45.0  (12.4) 45.2  (12.3) 45.1  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 20 participants 41 participants
Female
18
  85.7%
18
  90.0%
36
  87.8%
Male
3
  14.3%
2
  10.0%
5
  12.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants 20 participants 41 participants
21 20 41
1.Primary Outcome
Title Post Operative Incentive Spirometry Volume
Hide Description 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.
Time Frame 1 week before surgery to the day after
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Experimental Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 21 20
Mean (Standard Deviation)
Unit of Measure: cc
1557.9  (814.67) 1458.33  (613.87)
2.Secondary Outcome
Title Level of Compliance
Hide Description [Not Specified]
Time Frame 3 days to 2 weeks after clinic visit on the day of surgery
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Oxygen Saturation
Hide Description [Not Specified]
Time Frame one week prior to surgery up to one day after
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Heart Rate
Hide Description [Not Specified]
Time Frame one week prior to surgery to post operative day 1
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Respiratory Rate
Hide Description [Not Specified]
Time Frame one week prior to surgery to post operative day 1
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Group Experimental Group
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Control Group Experimental Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control Group Experimental Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Control Group Experimental Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/20 (0.00%) 
Our analysis was limited to measuring lung volumes up until postoperative day 1.Extending this study a few days postoperatively likely would allow us to achieve a better understanding of the course of respiratory function recovery.
Certain Agreements
Principal Investigators are NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Davide Cattano
Organization: University of Texas at Houston Medical School / Dept. of Anesthesiology
Phone: 713-500-6235
EMail: davide.cattano@uth.tmc.edu
Layout table for additonal information
Responsible Party: Davide Cattano, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01004146     History of Changes
Other Study ID Numbers: HSC-MS-08-0622
First Submitted: March 30, 2009
First Posted: October 29, 2009
Results First Submitted: June 17, 2013
Results First Posted: February 3, 2014
Last Update Posted: February 3, 2014