Use of Disposable Spirometer for Recovery of Pulmonary Function

NCT01789177 | Completed

• 1 other identifier: 13-0055
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complications

Keywords

Spirometry; Postoperative Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of postoperative pulmonary complications

  postoperative course until discharge

Study Arms (2)

Modified incentive spirometry

EXPERIMENTAL

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

Device: Incentive Spirometry; Other: Postoperative chest physiotherapy

Postoperative chest physiotherapy

ACTIVE COMPARATOR

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

Other: Postoperative chest physiotherapy

Interventions

Incentive Spirometry DEVICE

Patients will be provided with plastic, disposable incentive spirometers postoperatively

Modified incentive spirometry

Postoperative chest physiotherapy OTHER

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

Modified incentive spirometry; Postoperative chest physiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients who undergo laparotomy at Kamuzu Central Hospital, Malawi

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

Kamuzu Central Hospital

Lilongwe, Malawi

Location

Related Publications (8)

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

  PMID: 7759282 BACKGROUND

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

  PMID: 20150855 BACKGROUND

• 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.

  PMID: 19542885 BACKGROUND

• 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.

  PMID: 18362624 BACKGROUND

• 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.

  PMID: 16618957 BACKGROUND

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

  PMID: 22008401 BACKGROUND

• 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.

  PMID: 18080608 BACKGROUND

• 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.

  PMID: 25607594 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anthony G Charles, MD

  UNC Department of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2013
• First Posted: February 11, 2013
• Study Start: January 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 12, 2017

Record last verified: 2014-03

Locations

MA (1)