Incentive Spirometry Prehabilitation Study

NCT03994848 | Completed DMC

• 1 other identifier: Spirometry
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Lung Volumes

  Mean Lung Volumes

  From the time of admission to the pre-operative holding area to 72 hours post-operatively

Study Arms (2)

Control

NO INTERVENTION

Spirometry Group

EXPERIMENTAL

Behavioral: Spirometry Group

Interventions

Spirometry Group BEHAVIORAL

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

Spirometry Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Jeffrey Dobyns, DO, MSHA

  University of Alabama at Birmingham

  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: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: June 21, 2019
• Study Start: September 18, 2019
• Primary Completion: March 13, 2020
• Study Completion: September 1, 2020
• Last Updated: December 30, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)