Use of Disposable Spirometer for Recovery of Pulmonary Function

NCT ID: NCT01789177

Last Updated: 2017-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-12-31

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.

Conditions

Postoperative Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Modified incentive spirometry

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

Group Type: EXPERIMENTAL

Incentive Spirometry

Intervention Type: DEVICE

Patients will be provided with plastic, disposable incentive spirometers postoperatively

Postoperative chest physiotherapy

Intervention Type: OTHER

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

Postoperative chest physiotherapy

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

Group Type: ACTIVE_COMPARATOR

Postoperative chest physiotherapy

Intervention Type: OTHER

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

Interventions

Incentive Spirometry

Patients will be provided with plastic, disposable incentive spirometers postoperatively

Intervention Type: DEVICE

Postoperative chest physiotherapy

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony G Charles, MD

Role: PRINCIPAL_INVESTIGATOR

UNC Department of Surgery

Locations

Kamuzu Central Hospital

Lilongwe, , Malawi

Countries

Malawi

References

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

Reference Type: BACKGROUND

PMID: 7759282 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 20150855 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19542885 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18362624 (View on PubMed)

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. doi: 10.7326/0003-4819-144-8-200604180-00011.

Reference Type: BACKGROUND

PMID: 16618957 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 22008401 (View on PubMed)

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. doi: 10.1016/s1479-666x(07)80086-2.

Reference Type: BACKGROUND

PMID: 18080608 (View on PubMed)

Tyson AF, Kendig CE, Mabedi C, Cairns BA, Charles AG. The effect of incentive spirometry on postoperative pulmonary function following laparotomy: a randomized clinical trial. JAMA Surg. 2015 Mar 1;150(3):229-36. doi: 10.1001/jamasurg.2014.1846.

Reference Type: DERIVED

PMID: 25607594 (View on PubMed)

Other Identifiers

13-0055

Identifier Type: -

Identifier Source: org_study_id