Use of Disposable Spirometer for Recovery of Pulmonary Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anna Tyson, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01789177
First received: February 7, 2013
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Postoperative Complications
Device: Incentive Spirometry
Other: Postoperative chest physiotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Use of Disposable Spirometer for Recovery of Pulmonary Function by Peak Expiratory Flow Measurement Following Exploratory Laparotomy

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Return to baseline or predicted pulmonary function [ Time Frame: postoperative course up to discharge ] [ Designated as safety issue: No ]
    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 [ Time Frame: postoperative course until discharge ] [ Designated as safety issue: Yes ]
    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


Enrollment: 150
Study Start Date: January 2013
Study Completion Date: December 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Modified incentive spirometry
Patients will be given a disposable incentive spirometer postoperatively and instructed to use the spirometer every hour while awake.
Device: Incentive Spirometry
Patients will be provided with plastic, disposable incentive spirometers postoperatively
Other: Postoperative chest physiotherapy
Patients will be given routine postoperative chest physiotherapy instruction by nursing staff
Active Comparator: Postoperative chest physiotherapy
Patients will be given standard postoperative chest physiotherapy, according to hospital protocol, but will not receive incentive spirometers.
Other: Postoperative chest physiotherapy
Patients will be given routine postoperative chest physiotherapy instruction by nursing staff

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01789177

Locations
Malawi
Kamuzu Central Hospital
Lilongwe, Malawi
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Anthony G Charles, MD UNC Department of Surgery
  More Information

Publications:
Responsible Party: Anna Tyson, MD, Principal On-site Investigator, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01789177     History of Changes
Other Study ID Numbers: 13-0055
Study First Received: February 7, 2013
Last Updated: March 5, 2014
Health Authority: United States: Institutional Review Board
Malawi: National Health Sciences Review Committee

Keywords provided by University of North Carolina, Chapel Hill:
Spirometry
Postoperative Care

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014