Clinical trial NCT03994848: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-06-21
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Lung Volumes
timeFrame: From the time of admission to the pre-operative holding area to 72 hours post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Jeffrey Dobyns, DO, MSHA
role: PRINCIPAL_INVESTIGATOR
References: