The effect of incentive spirometry on postoperative pulmonary function following laparotomy: a randomized clinical trial.

IMPORTANCE: Changes in pulmonary dynamics following laparotomy are well documented. Deep breathing exercises, with or without incentive spirometry, may help counteract postoperative decreased vital capacity; however, the evidence for the role of incentive spirometry in the prevention of postoperative atelectasis is inconclusive. Furthermore, data are scarce regarding the prevention of postoperative atelectasis in sub-Saharan Africa.
OBJECTIVE: To determine the effect of the use of incentive spirometry on pulmonary function following exploratory laparotomy as measured by forced vital capacity (FVC). DESIGN, SETTING, AND PARTICIPANTS: This was a single-center, randomized clinical trial performed at Kamuzu Central Hospital, Lilongwe, Malawi. Study participants were adult patients who underwent exploratory laparotomy and were randomized into the intervention or control groups (standard of care) from February 1 to November 30, 2013. All patients received routine postoperative care, including instructions for deep breathing and early ambulation. We used bivariate analysis to compare outcomes between the intervention and control groups. INTERVENTION: Adult patients who underwent exploratory laparotomy participated in postoperative deep breathing exercises. Patients in the intervention group received incentive spirometers. MAIN OUTCOMES AND MEASURES: We assessed pulmonary function using a peak flow meter to measure FVC in both groups of patients. Secondary outcomes, such as hospital length of stay and mortality, were obtained from the medical records.
RESULTS: A total of 150 patients were randomized (75 in each arm). The median age in the intervention and control groups was 35 years (interquartile range, 28-53 years) and 33 years (interquartile range, 23-46 years), respectively. Men predominated in both groups, and most patients underwent emergency procedures (78.7% in the intervention group and 84.0% in the control group). Mean initial FVC did not differ significantly between the intervention and control groups (0.92 and 0.90 L, respectively; P=.82 [95% CI, 0.52-2.29]). Although patients in the intervention group tended to have higher final FVC measurements, the change between the first and last measured FVC was not statistically significant (0.29 and 0.25 L, respectively; P=.68 [95% CI, 0.65-1.95]). Likewise, hospital length of stay did not differ significantly between groups. Overall postoperative mortality was 6.0%, with a higher mortality rate in the control group compared with the intervention group (10.7% and 1.3%, respectively; P=.02 [95% CI, 0.01-0.92]). CONCLUSIONS AND RELEVANCE: Education and provision of incentive spirometry for unmonitored patient use does not result in statistically significant improvement in pulmonary dynamics following laparotomy. We would not recommend the addition of incentive spirometry to the current standard of care in this resource-constrained environment. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01789177.

RCT Entities:   Population Interventions Outcomes