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Clinical Trials/NCT03994848
NCT03994848
Completed
N/A

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

University of Alabama at Birmingham1 site in 1 country23 target enrollmentSeptember 18, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pulmonary Disease
Sponsor
University of Alabama at Birmingham
Enrollment
23
Locations
1
Primary Endpoint
Lung Volumes
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 18, 2019
End Date
September 1, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jeffry B. Dobyns

Principal Investigator

University of Alabama at Birmingham

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

Outcomes

Primary Outcomes

Lung Volumes

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

Mean Lung Volumes

Study Sites (1)

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