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

  • Malawi
      • Lilongwe, Malawi
        • Kamuzu Central Hospital

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.
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

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
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)
postoperative course up to discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of postoperative pulmonary complications
Time Frame: postoperative course until discharge
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
postoperative course until discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

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

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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