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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

Tracking Information
First Submitted Date  ICMJE March 30, 2009
First Posted Date  ICMJE October 29, 2009
Results First Submitted Date  ICMJE June 17, 2013
Results First Posted Date  ICMJE February 3, 2014
Last Update Posted Date February 3, 2014
Study Start Date  ICMJE March 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2013)
Post Operative Incentive Spirometry Volume [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 28, 2009)
incentive spirometry volume [ Time Frame: 1 week before surgery to the day after ]
Change History Complete list of historical versions of study NCT01004146 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2009)
  • Level of Compliance [ Time Frame: 3 days to 2 weeks after clinic visit on the day of surgery ]
  • Oxygen Saturation [ Time Frame: one week prior to surgery up to one day after ]
  • Heart Rate [ Time Frame: one week prior to surgery to post operative day 1 ]
  • Respiratory Rate [ Time Frame: one week prior to surgery to post operative day 1 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pre-op Use of Incentive Spirometry in Obese Patients
Official Title  ICMJE A Study on the Preoperative Use of Incentive Spirometry in Morbidly Obese Patients Undergoing General Anesthesia
Brief Summary The purpose of this study is to evaluate the use of preoperative incentive spirometry (IS) as an aid to improve postoperative lung function. The hypothesis is that application of a standardized protocol of preoperative respiratory care teaching and exercise will improve lung performance that will subsequently result in prevention of postoperative pulmonary complications and that increasing the duration of preoperative use better improves lung mechanics postoperatively. The investigators propose to compare a patient population that uses IS as currently prescribed in the routine course of care (only to be familiar with preoperatively, but use postoperatively) against a population that uses IS with a standardized regimen for at least 3 days prior to the operation in terms of preoperative IS volumes, intraoperative pulmonary mechanics, postoperative IS volumes, and incidence of postoperative pulmonary complications.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Lung Function
  • Bariatric Surgery
Intervention  ICMJE Procedure: Incentive Spirometry
helps patient monitor their inspiratory tidal volume and assists in the preventing lower airway collapse
Study Arms  ICMJE
  • Placebo Comparator: Control group
    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.
    Intervention: Procedure: Incentive Spirometry
  • Experimental: Experimental Group
    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.
    Intervention: Procedure: Incentive Spirometry
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 28, 2009)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • morbid obesity
  • bariatric surgery
  • must be able to use incentive spirometer

Exclusion Criteria:

  • BMI=<40 kg/m2
  • current symptoms of obstructive sleep apnea or actively using continuous positive airway pressure
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01004146
Other Study ID Numbers  ICMJE HSC-MS-08-0622
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Davide Cattano, The University of Texas Health Science Center, Houston
Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Davide Cattano, M.D. University of Texas Medical School
PRS Account The University of Texas Health Science Center, Houston
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP