Skip to main content
OpenTrials
Completed

NCT Number: NCT01789177

Use of Disposable Spirometer for Recovery of Pulmonary Function

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kamuzu Central Hospital

Lilongwe, Malawi

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Incentive spirometry

Device

Patients will be provided with plastic, disposable incentive spirometers postoperatively

Postoperative chest physiotherapy

Other

Patients will be given routine postoperative chest physiotherapy instruction by nursing staff

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

Use of Disposable Spirometer for Recovery of Pulmonary Function by Peak Expiratory Flow Measurement Following Exploratory Laparotomy

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 11, 2013
Registry last updated
Dec 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.