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Use of Disposable Spirometer for Recovery of Pulmonary Function

Primary Purpose

Postoperative Complications

Status
Completed
Phase
Not Applicable
Locations
Malawi
Study Type
Interventional
Intervention
Incentive Spirometry
Postoperative chest physiotherapy
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Complications focused on measuring Spirometry, Postoperative Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kamuzu Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Modified incentive spirometry

Postoperative chest physiotherapy

Arm Description

Patients will be given a disposable incentive spirometer postoperatively and instructed to use the spirometer every hour while awake.

Patients will be given standard postoperative chest physiotherapy, according to hospital protocol, but will not receive incentive spirometers.

Outcomes

Primary Outcome Measures

Return to baseline or predicted pulmonary function
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)

Secondary Outcome Measures

Incidence of postoperative pulmonary complications
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

Full Information

First Posted
February 7, 2013
Last Updated
December 8, 2017
Sponsor
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT01789177
Brief Title
Use of Disposable Spirometer for Recovery of Pulmonary Function
Official Title
Use of Disposable Spirometer for Recovery of Pulmonary Function by Peak Expiratory Flow Measurement Following Exploratory Laparotomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications
Keywords
Spirometry, Postoperative Care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Modified incentive spirometry
Arm Type
Experimental
Arm Description
Patients will be given a disposable incentive spirometer postoperatively and instructed to use the spirometer every hour while awake.
Arm Title
Postoperative chest physiotherapy
Arm Type
Active Comparator
Arm Description
Patients will be given standard postoperative chest physiotherapy, according to hospital protocol, but will not receive incentive spirometers.
Intervention Type
Device
Intervention Name(s)
Incentive Spirometry
Intervention Description
Patients will be provided with plastic, disposable incentive spirometers postoperatively
Intervention Type
Other
Intervention Name(s)
Postoperative chest physiotherapy
Intervention Description
Patients will be given routine postoperative chest physiotherapy instruction by nursing staff
Primary Outcome Measure Information:
Title
Return to baseline or predicted pulmonary function
Description
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)
Time Frame
postoperative course up to discharge
Secondary Outcome Measure Information:
Title
Incidence of postoperative pulmonary complications
Description
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
Time Frame
postoperative course until discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony G Charles, MD
Organizational Affiliation
UNC Department of Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kamuzu Central Hospital
City
Lilongwe
Country
Malawi

12. IPD Sharing Statement

Citations:
PubMed Identifier
7759282
Citation
Brooks-Brunn JA. Postoperative atelectasis and pneumonia. Heart Lung. 1995 Mar-Apr;24(2):94-115.
Results Reference
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PubMed Identifier
20150855
Citation
Canet J, Mazo V. Postoperative pulmonary complications. Minerva Anestesiol. 2010 Feb;76(2):138-43. Epub 2009 Nov 24.
Results Reference
background
PubMed Identifier
19542885
Citation
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.
Results Reference
background
PubMed Identifier
18362624
Citation
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.
Results Reference
background
PubMed Identifier
16618957
Citation
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.
Results Reference
background
PubMed Identifier
22008401
Citation
Restrepo RD, Wettstein R, Wittnebel L, Tracy M. Incentive spirometry: 2011. Respir Care. 2011 Oct;56(10):1600-4. doi: 10.4187/respcare.01471.
Results Reference
background
PubMed Identifier
18080608
Citation
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.
Results Reference
background
PubMed Identifier
25607594
Citation
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.
Results Reference
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Use of Disposable Spirometer for Recovery of Pulmonary Function

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