- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01789177
Use of Disposable Spirometer for Recovery of Pulmonary Function
December 8, 2017 updated by: University of North Carolina, Chapel Hill
Use of Disposable Spirometer for Recovery of Pulmonary Function by Peak Expiratory Flow Measurement Following Exploratory Laparotomy
We hypothesize that the addition of modified incentive spirometry to standard postoperative chest physiotherapy will be associated with faster return to baseline/predicted pulmonary function and fewer postoperative pulmonary complications in patients following laparotomy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The primary objective of this study is to determine how quickly patients' peak expiratory flow measurement returns to baseline or predicted values following laparotomy with or without the assistance of modified incentive spirometry.
The secondary objective is to assess the effectiveness of modified incentive spirometry in preventing postoperative pulmonary complications in patients following laparotomy.
Specifically, this study will track length of stay, mortality, and evidence of pulmonary infection in both treatment and non-treatment arms.
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Lilongwe, Malawi
- Kamuzu Central Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult patients who undergo laparotomy at Kamuzu Central Hospital, Malawi
Exclusion Criteria:
- Patients with known pre-existing pulmonary disease
- Pregnant women
- Patients who cannot perform maximal expiration for measurement of peak expiratory flow meter because of inability to understand or follow directions and demonstrations
- Patients with terminal cancer or illness with life-expectancy less than 1 month
- Patients with burn injuries
- Patients with illness requiring intubation and mechanical ventilation or postoperative ICU admission
- Patients who require additional operations during the course of their hospital stay
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Modified incentive spirometry
Patients will be given a disposable incentive spirometer postoperatively and instructed to use the spirometer every hour while awake.
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Patients will be provided with plastic, disposable incentive spirometers postoperatively
Patients will be given routine postoperative chest physiotherapy instruction by nursing staff
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ACTIVE_COMPARATOR: Postoperative chest physiotherapy
Patients will be given standard postoperative chest physiotherapy, according to hospital protocol, but will not receive incentive spirometers.
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Patients will be given routine postoperative chest physiotherapy instruction by nursing staff
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Return to baseline or predicted pulmonary function
Time Frame: postoperative course up to discharge
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Return to baseline/predicted pulmonary function based on peak expiratory flow measurement.
Postoperative measurement will be compared to preoperative measurement (for elective cases) or age-predicted measurement (for emergency cases)
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postoperative course up to discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of postoperative pulmonary complications
Time Frame: postoperative course until discharge
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We will measure length of hospital course, mortality, and incidence of pneumonia, pleural effusion, or other postoperative pulmonary complication based on clinical diagnosis and available radiological studies
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postoperative course until discharge
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Anthony G Charles, MD, UNC Department of Surgery
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ferreyra GP, Baussano I, Squadrone V, Richiardi L, Marchiaro G, Del Sorbo L, Mascia L, Merletti F, Ranieri VM. Continuous positive airway pressure for treatment of respiratory complications after abdominal surgery: a systematic review and meta-analysis. Ann Surg. 2008 Apr;247(4):617-26. doi: 10.1097/SLA.0b013e3181675829.
- Brooks-Brunn JA. Postoperative atelectasis and pneumonia. Heart Lung. 1995 Mar-Apr;24(2):94-115.
- Canet J, Mazo V. Postoperative pulmonary complications. Minerva Anestesiol. 2010 Feb;76(2):138-43. Epub 2009 Nov 24.
- Ferreyra G, Long Y, Ranieri VM. Respiratory complications after major surgery. Curr Opin Crit Care. 2009 Aug;15(4):342-8. doi: 10.1097/MCC.0b013e32832e0669.
- Lawrence VA, Cornell JE, Smetana GW; American College of Physicians. Strategies to reduce postoperative pulmonary complications after noncardiothoracic surgery: systematic review for the American College of Physicians. Ann Intern Med. 2006 Apr 18;144(8):596-608. doi: 10.7326/0003-4819-144-8-200604180-00011.
- Restrepo RD, Wettstein R, Wittnebel L, Tracy M. Incentive spirometry: 2011. Respir Care. 2011 Oct;56(10):1600-4. doi: 10.4187/respcare.01471.
- Westwood K, Griffin M, Roberts K, Williams M, Yoong K, Digger T. Incentive spirometry decreases respiratory complications following major abdominal surgery. Surgeon. 2007 Dec;5(6):339-42. doi: 10.1016/s1479-666x(07)80086-2.
- Tyson AF, Kendig CE, Mabedi C, Cairns BA, Charles AG. The effect of incentive spirometry on postoperative pulmonary function following laparotomy: a randomized clinical trial. JAMA Surg. 2015 Mar 1;150(3):229-36. doi: 10.1001/jamasurg.2014.1846.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (ACTUAL)
November 1, 2013
Study Completion (ACTUAL)
December 1, 2013
Study Registration Dates
First Submitted
February 7, 2013
First Submitted That Met QC Criteria
February 7, 2013
First Posted (ESTIMATE)
February 11, 2013
Study Record Updates
Last Update Posted (ACTUAL)
December 12, 2017
Last Update Submitted That Met QC Criteria
December 8, 2017
Last Verified
March 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-0055
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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