Incentive Spirometry Prehabilitation Study

Pulmonary Disease Clinical Trial

Official title:

Pulmonary Prehabilitation With Incentive Spirometry in Patients Undergoing One-Lung Ventilation and the Effect on Postoperative Lung Function: A Randomized-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03994848
• Other study ID #: Spirometry
• Status: Completed
• Phase: N/A
• Start date: September 18, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: December 2021
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 1, 2020
• Est. primary completion date: March 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease

Intervention

Behavioral:
• Spirometry Group
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

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung Volumes	Mean Lung Volumes	From the time of admission to the pre-operative holding area to 72 hours post-operatively