Use of Disposable Spirometer for Recovery of Pulmonary Function

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01789177
• Other study ID #: 13-0055
• Status: Completed
• Phase: N/A
• First received: February 7, 2013
• Last updated: December 8, 2017
• Start date: January 2013
• Est. completion date: December 2013

Study information

• Verified date: March 2014
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

Device:
• Incentive Spirometry
Patients will be provided with plastic, disposable incentive spirometers postoperatively

Other:
• Postoperative chest physiotherapy
Patients will be given routine postoperative chest physiotherapy instruction by nursing staff

Locations

Country	Name	City	State
Malawi	Kamuzu Central Hospital	Lilongwe

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

Malawi, 

References & Publications (7)

Brooks-Brunn JA. Postoperative atelectasis and pneumonia. Heart Lung. 1995 Mar-Apr;24(2):94-115. Review. — View Citation

Canet J, Mazo V. Postoperative pulmonary complications. Minerva Anestesiol. 2010 Feb;76(2):138-43. Epub 2009 Nov 24. Review. — View Citation

Ferreyra G, Long Y, Ranieri VM. Respiratory complications after major surgery. Curr Opin Crit Care. 2009 Aug;15(4):342-8. doi: 10.1097/MCC.0b013e32832e0669. Review. — View Citation

Ferreyra GP, Baussano I, Squadrone V, Richiardi L, Marchiaro G, Del Sorbo L, Mascia L, Merletti F, Ranieri VM. Continuous positive airway pressure for treatment of respiratory complications after abdominal surgery: a systematic review and meta-analysis. Ann Surg. 2008 Apr;247(4):617-26. doi: 10.1097/SLA.0b013e3181675829. Review. — View Citation

Lawrence VA, Cornell JE, Smetana GW; American College of Physicians. Strategies to reduce postoperative pulmonary complications after noncardiothoracic surgery: systematic review for the American College of Physicians. Ann Intern Med. 2006 Apr 18;144(8):596-608. Review. — View Citation

Restrepo RD, Wettstein R, Wittnebel L, Tracy M. Incentive spirometry: 2011. Respir Care. 2011 Oct;56(10):1600-4. doi: 10.4187/respcare.01471. — View Citation

Westwood K, Griffin M, Roberts K, Williams M, Yoong K, Digger T. Incentive spirometry decreases respiratory complications following major abdominal surgery. Surgeon. 2007 Dec;5(6):339-42. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Return to baseline or predicted pulmonary function	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)	postoperative course up to discharge
Secondary	Incidence of postoperative pulmonary complications	We 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	postoperative course until discharge