Incentive Spirometry Prehabilitation Study

Not Applicable

Completed

• Conditions: Pulmonary Disease
• Interventions: Behavioral: Spirometry Group

• Registration Number: NCT03994848
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-19
• Study First Submitted QC: 2019-06-19
• Study First Posted: 2019-06-21
• Study Start: 2019-09-18
• Primary Completion: 2020-03-13
• Study Completion: 2020-09-01
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-28
• Last Update Posted: 2021-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spirometry Group	Spirometry Group	-

Primary Outcome Measures

Name	Time	Method
Lung Volumes	From the time of admission to the pre-operative holding area to 72 hours post-operatively	Mean Lung Volumes

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States