Use of Disposable Spirometer for Recovery of Pulmonary Function by Peak Expiratory Flow Measurement Following Exploratory Laparotomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Return to baseline or predicted pulmonary function
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Modified incentive spirometry
Patients will be given a disposable incentive spirometer postoperatively and instructed to use the spirometer every hour while awake.
Intervention: Incentive Spirometry (Device)
Modified incentive spirometry
Patients will be given a disposable incentive spirometer postoperatively and instructed to use the spirometer every hour while awake.
Intervention: Postoperative chest physiotherapy (Other)
Postoperative chest physiotherapy
Patients will be given standard postoperative chest physiotherapy, according to hospital protocol, but will not receive incentive spirometers.
Intervention: Postoperative chest physiotherapy (Other)
Outcomes
Primary Outcomes
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
- Incidence of postoperative pulmonary complications(postoperative course until discharge)