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OpenTrials
Completed

NCT Number: NCT03994848

Incentive Spirometry Prehabilitation Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Lung Volumes

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

    Mean Lung Volumes

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 21, 2019
Registry last updated
Dec 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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