Use of Disposable Spirometer for Recovery of Pulmonary Function

Not Applicable

Completed

• Conditions: Postoperative Complications
• Interventions: Other: Postoperative chest physiotherapy; Device: Incentive Spirometry

• Registration Number: NCT01789177
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-02-07
• Study First Submitted QC: 2013-02-07
• Study First Posted: 2013-02-11
• Primary Completion: 2013-11
• Study Completion: 2013-12
• Status Verified: 2014-03
• Last Update Submitted: 2017-12-08
• Last Update Posted: 2017-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Adult patients who undergo laparotomy at Kamuzu Central Hospital, Malawi

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Postoperative chest physiotherapy	Postoperative chest physiotherapy	Patients will be given standard postoperative chest physiotherapy, according to hospital protocol, but will not receive incentive spirometers.
Modified incentive spirometry	Postoperative chest physiotherapy	Patients will be given a disposable incentive spirometer postoperatively and instructed to use the spirometer every hour while awake.
Modified incentive spirometry	Incentive Spirometry	Patients will be given a disposable incentive spirometer postoperatively and instructed to use the spirometer every hour while awake.

Primary Outcome Measures

Name	Time	Method
Return to baseline or predicted pulmonary function	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 Outcome Measures

Name	Time	Method
Incidence of postoperative pulmonary complications	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

Trial Locations

Locations (1)

Kamuzu Central Hospital; 🇲🇼 Lilongwe, Malawi