Use of Disposable Spirometer for Recovery of Pulmonary Function

University of North Carolina (UNC)

Status: Completed

Conditions: Postoperative Complications

Treatments: Device: Incentive Spirometry; Other: Postoperative chest physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01789177

13-0055

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Modified incentive spirometry

Experimental group

Description:

Patients will be given a disposable incentive spirometer postoperatively and instructed to use the spirometer every hour while awake.

Treatment:

Other: Postoperative chest physiotherapy

Device: Incentive Spirometry

Postoperative chest physiotherapy

Active Comparator group

Description:

Patients will be given standard postoperative chest physiotherapy, according to hospital protocol, but will not receive incentive spirometers.

Treatment:

Other: Postoperative chest physiotherapy