Viewing Study NCT03994848



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Last Modification Date: 2024-10-26 @ 1:12 PM
Study NCT ID: NCT03994848
Status: COMPLETED
Last Update Posted: 2021-12-30
First Post: 2019-06-19

Brief Title: Incentive Spirometry Prehabilitation Study
Sponsor: University of Alabama at Birmingham
Organization: University of Alabama at Birmingham

Study Overview

Official Title: Pulmonary Prehabilitation With Incentive Spirometry in Patients Undergoing One-Lung Ventilation and the Effect on Postoperative Lung Function A Randomized-Controlled Trial
Status: COMPLETED
Status Verified Date: 2021-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None