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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04732143
Recruitment Status : Recruiting
First Posted : February 1, 2021
Last Update Posted : May 18, 2021
Sponsor:
Information provided by (Responsible Party):
Pauline Go, Milton S. Hershey Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Postoperative Respiratory Complication Other: Inspiratory muscle training Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Preoperative Inspiratory Muscle Training Using Incentive Spirometer on Postoperative Pulmonary Complications Following Lung Resection
Actual Study Start Date : April 27, 2021
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 31, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Incentive Spirometry
Participants will undergo inspiratory muscle training using an incentive spirometer daily for 14 days prior to surgery.
 Other: 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.
Other Name: Incentive spirometry
No Intervention: Standard Care
Participants will not undergo any inspiratory muscle training prior to surgery.


Outcome Measures
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Primary Outcome Measures :
  1. Atelectasis [ Time Frame: Through completion of follow-up (30 days) ]
    Incidence of atelectasis requiring bronchoscopy or additional bedside therapy by a respiratory therapist

  2. Pneumonia [ Time Frame: Through completion of follow-up (30 days) ]
    Clinical and/or radiographic evidence of pneumonia requiring antibiotic therapy

  3. Respiratory failure [ Time Frame: Through completion of follow-up (30 days) ]
    Incidence of respiratory failure requiring re-intubation or high flow nasal cannula and/or non-invasive positive pressure ventilation

  4. Pleural effusion [ Time Frame: Through completion of follow-up (30 days) ]
    Incidence of pleural effusion requiring drainage or other medical intervention (e.g. use of diuretics)

  5. Pneumothorax or subcutaneous emphysema [ Time Frame: Through completion of follow-up (30 days) ]
    Incidence of clinically significant pneumothorax or subcutaneous emphysema requiring intervention or extended hospital admission for observation

  6. Prolonged air leak [ Time Frame: Through completion of follow-up (30 days) ]
    Incidence of prolonged air leak (>5 days) or requiring discharge with chest tube

  7. Need for supplemental oxygen [ Time Frame: Through completion of follow-up (30 days) ]
    Incidence of patients requiring supplemental oxygen upon discharge

  8. Empyema/bronchopleural fistula [ Time Frame: Through completion of follow-up (30 days) ]
    Incidence of empyema and/or bronchopleural fistula confirmed by fluid analysis and/or cultures

  9. Cardiac arrhythmia [ Time Frame: Through completion of follow-up (30 days) ]
    Incidence of cardiac arrhythmia requiring intervention (e.g. atrial fibrillation, supraventricular tachycardia, etc.)


Secondary Outcome Measures :
  1. Hospital length of stay [ Time Frame: Through completion of follow-up (30 days) ]
    Total length of index admission following surgery

  2. ICU length of stay [ Time Frame: Through completion of follow-up (30 days) ]
    If participant required ICU admission

  3. Chest tube duration [ Time Frame: Through completion of follow-up (30 days) ]
    Number of days from chest tube insertion (surgery date) until chest tube removal

  4. Hospital readmission [ Time Frame: Through completion of follow-up (30 days) ]
    Participant visited an emergency department and/or was admitted to the hospital following discharge from the index admission for any reason.

  5. Change from baseline in dyspnea, measured by the modified Medical Research Council scale [ Time Frame: Baseline, 2 weeks and 4 weeks after surgery ]
    Scores are measured on a scale from 0 to 4, with 0 indicating dyspnea only with strenuous exercise and 4 indicating participant is too dyspneic to leave the house or breathless when dressing

  6. Mortality [ Time Frame: Through completion of follow-up (30 days) ]
    Death from any cause


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04732143


Contacts
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Contact: Pauline H Go, MD 717-531-5429 paulinego@pennstatehealth.psu.edu
Contact: Rolfy Perez Holguin, MD rperezholguin@pennstatehealth.psu.edu

Locations
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United States, Pennsylvania
Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Pauline H Go, MD    717-531-5429    paulinego@pennstatehealth.psu.edu   
Contact: Rolfy Perez Holguin, MD       rperezholguin@pennstatehealth.psu.edu   
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: Pauline H Go, MD Milton S. Hershey Medical Center
More Information
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Publications:

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Responsible Party: Pauline Go, Associate Professor of Surgery, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT04732143    
Other Study ID Numbers: STUDY00015501
First Posted: February 1, 2021    Key Record Dates
Last Update Posted: May 18, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pauline Go, Milton S. Hershey Medical Center:
Incentive Spirometry
Inspiratory Muscle Training
Pulmonary Resection