Effect of Preoperative Incentive Spirometer on Postoperative Pulmonary Complications Following Lung Resection

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

TERMINATED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-27

Study Completion Date

2023-06-07

Brief Summary

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The objective of this study is to demonstrate that inspiratory muscle training with daily use of an incentive spirometer for at least 14 days prior to lung surgery will reduce the risk of post-operative pulmonary complications.

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Detailed Description

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Postoperative pulmonary complications (PPC) are the most common adverse events following lung resection, with a reported incidence of over 20-30% in some series. The objective of this study is to demonstrate that inspiratory muscle training (IMT) with daily use of an incentive spirometer (IS) for at least 14 days prior to lung surgery will reduce the risk of PPCs compared to the usual care, consisting of no formal preoperative IMT. The hypothesis is that preoperative inspiratory spirometer breathing (ISB) is a feasible and cost-effective intervention that can significantly reduce PPCs after lung resection. It is also hypothesized that patient compliance with the intervention will be high because of its simplicity, convenience, low cost and no potential for adverse effects.

Conditions

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Postoperative Respiratory Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Incentive Spirometry

Participants will undergo inspiratory muscle training using an incentive spirometer daily for 14 days prior to surgery.

Group Type EXPERIMENTAL

Inspiratory muscle training

Intervention Type OTHER

At least 2 weeks prior to surgery, participants will be given a Vyaire incentive spirometer device and provided with formal training on proper inspiratory muscle breathing exercise using the device. They will be instructed to perform 4 sets of these exercises per day for 14 days prior to surgery.

Standard Care

Participants will not undergo any inspiratory muscle training prior to surgery.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Inspiratory muscle training

At least 2 weeks prior to surgery, participants will be given a Vyaire incentive spirometer device and provided with formal training on proper inspiratory muscle breathing exercise using the device. They will be instructed to perform 4 sets of these exercises per day for 14 days prior to surgery.

Intervention Type OTHER

Other Intervention Names

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Incentive spirometry

Eligibility Criteria

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Inclusion Criteria

* ECOG performance status score 2 or less
* Undergoing elective lung resection (includes wedge resection, lobectomy, bi-lobectomy, pneumonectomy, sleeve resection) via minimally invasive (VATS or robotic) approach or thoracotomy
* Chest wall resection if performed concurrently with lung resection

Exclusion Criteria

* ECOG performance status score greater than 2
* Significant cognitive impairment preventing informed consent
* Non-English speaking
* Wedge biopsy for interstitial lung disease
* Bullectomy for bullous emphysema
* Pre-existing tracheostomy
* Emergent or urgent surgery
* Preoperative home oxygen use
* History of neuromuscular disease
* Prisoners

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes