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Use of Disposable Spirometer for Recovery of Pulmonary Function

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01789177
Enrollment
150
Registered
2013-02-11
Start date
2013-01-31
Completion date
2013-12-31
Last updated
2017-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Complications

Keywords

Spirometry, Postoperative Care

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.

Interventions

DEVICEIncentive Spirometry

Patients will be provided with plastic, disposable incentive spirometers postoperatively

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

Sponsors

University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Return to baseline or predicted pulmonary functionpostoperative course up to dischargeReturn 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

MeasureTime frameDescription
Incidence of postoperative pulmonary complicationspostoperative course until dischargeWe 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

Countries

Malawi

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026