Use of Disposable Spirometer for Recovery of Pulmonary Function

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postoperative Complications

Intervention / Treatment
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* Device: Incentive Spirometry
* Other: Postoperative chest physiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified incentive spirometry<br>Patients will be given a disposable incentive spirometer postoperatively and instructed to use the spirometer every hour while awake. | Device: Incentive Spirometry<br>* Patients will be provided with plastic, disposable incentive spirometers postoperatively<br>Other: Postoperative chest physiotherapy<br>* Patients will be given routine postoperative chest physiotherapy instruction by nursing staff<br>|
| Active Comparator: Postoperative chest physiotherapy<br>Patients will be given standard postoperative chest physiotherapy, according to hospital protocol, but will not receive incentive spirometers. | Other: Postoperative chest physiotherapy<br>* Patients will be given routine postoperative chest physiotherapy instruction by nursing staff<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | postoperative course up to discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | postoperative course until discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spirometry, Postoperative Care