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Incentive Spirometry Prehabilitation Study

NCT ID: NCT03994848

Last Updated: 2021-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-18

Study Completion Date

2020-09-01

Brief Summary

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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

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Conditions

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Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Spirometry Group

Group Type EXPERIMENTAL

Spirometry Group

Intervention Type 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

Interventions

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Spirometry Group

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Jeffry B. Dobyns

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeffrey Dobyns, DO, MSHA

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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Spirometry

Identifier Type: -

Identifier Source: org_study_id