Use of Disposable Spirometer for Recovery of Pulmonary Function

University of North Carolina (UNC) logo

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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