search
Back to results

Incentive Spirometry Prehabilitation Study

Primary Purpose

Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spirometry Group
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pulmonary Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients scheduled for thoracic surgery procedures involving one-lung ventilation
  • open thoracotomy
  • Video-assisted thoracoscopic surgery (VATS)
  • Robotic-assisted thoracoscopic surgery (RATS)
  • Procedures to include: Lung resection for any purpose, esophagectomy, thymectomy
  • Patients undergoing esophagectomy performed by a general surgeon
  • Patients willing and able to independently perform incentive spirometry

Exclusion Criteria:

  • Trauma patients
  • Lung Volume reduction surgery (LVRS)
  • In-Patients
  • Patients not undergoing one-lung ventilation
  • Patients undergoing thoracoabdominal aortic aneurysm repair
  • Transhiatal esophagectomy (does not involve one-lung ventilation)
  • Lung transplantation

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Spirometry Group

Arm Description

Outcomes

Primary Outcome Measures

Lung Volumes
Mean Lung Volumes

Secondary Outcome Measures

Full Information

First Posted
June 19, 2019
Last Updated
December 28, 2021
Sponsor
University of Alabama at Birmingham
search

1. Study Identification

Unique Protocol Identification Number
NCT03994848
Brief Title
Incentive Spirometry Prehabilitation Study
Official Title
Pulmonary Prehabilitation With Incentive Spirometry in Patients Undergoing One-Lung Ventilation and the Effect on Postoperative Lung Function: A Randomized-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
September 18, 2019 (Actual)
Primary Completion Date
March 13, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Postoperative pulmonary complications (PPCs) are the most common complication following thoracic surgery. PPCs are associated with prolonged hospital stay, increased morbidity, mortality, ICU admission, and healthcare costs (Azhar, 2015). Current preoperative optimization in this patient group includes smoking cessation and management of Chronic Obstructive Pulmonary Disease with inhaled bronchodilators and inhaled steroids as indicated. There have been studies using preoperative incentive spirometry in patients undergoing laparotomy with conflicting results, but scant data on its use in patients undergoing one-lung ventilation (Tyson, et al., 2015; Cattano, et al., 2010). A study from 2013 investigated the effectiveness of incentive spirometry in patients following thoracotomy and found conflicting results, without significant improvement in lung function or reduction in PPCs, but a larger difference in frequency of PPC was noted, indicating possible benefit to intervention and a need for further study (Agostini, et al., 2013). Volume-based incentive spirometry pre- and postoperatively has also been found to improve pulmonary function and diaphragm excursion in patients undergoing laparoscopic surgery (Alaparthi, et al., 2016). Patients customarily receive an incentive spirometer for use postoperatively in the PACU. There is scant data in the thoracic surgery population concerning prehabilitation by dispensing the incentive spirometer at the PACT evaluation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
Spirometry Group
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Spirometry Group
Intervention Description
Patients that are provided the incentive spirometer pre-operatively and instructed to use it for 4 cycles of 10 spirometry attempts on the day prior to surgery
Primary Outcome Measure Information:
Title
Lung Volumes
Description
Mean Lung Volumes
Time Frame
From the time of admission to the pre-operative holding area to 72 hours post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients scheduled for thoracic surgery procedures involving one-lung ventilation open thoracotomy Video-assisted thoracoscopic surgery (VATS) Robotic-assisted thoracoscopic surgery (RATS) Procedures to include: Lung resection for any purpose, esophagectomy, thymectomy Patients undergoing esophagectomy performed by a general surgeon Patients willing and able to independently perform incentive spirometry Exclusion Criteria: Trauma patients Lung Volume reduction surgery (LVRS) In-Patients Patients not undergoing one-lung ventilation Patients undergoing thoracoabdominal aortic aneurysm repair Transhiatal esophagectomy (does not involve one-lung ventilation) Lung transplantation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Dobyns, DO, MSHA
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Incentive Spirometry Prehabilitation Study

We'll reach out to this number within 24 hrs