NCT04732143

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 1, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

April 27, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2023

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

2.1 years

First QC Date

January 27, 2021

Last Update Submit

June 9, 2023

Conditions

Postoperative Respiratory Complication

Keywords

Incentive SpirometryInspiratory Muscle TrainingPulmonary Resection

Outcome Measures

Primary Outcomes (9)

  • Atelectasis

    Incidence of atelectasis requiring bronchoscopy or additional bedside therapy by a respiratory therapist

    Through completion of follow-up (30 days)

  • Pneumonia

    Clinical and/or radiographic evidence of pneumonia requiring antibiotic therapy

    Through completion of follow-up (30 days)

  • Respiratory failure

    Incidence of respiratory failure requiring re-intubation or high flow nasal cannula and/or non-invasive positive pressure ventilation

    Through completion of follow-up (30 days)

  • Pleural effusion

    Incidence of pleural effusion requiring drainage or other medical intervention (e.g. use of diuretics)

    Through completion of follow-up (30 days)

  • Pneumothorax or subcutaneous emphysema

    Incidence of clinically significant pneumothorax or subcutaneous emphysema requiring intervention or extended hospital admission for observation

    Through completion of follow-up (30 days)

  • Prolonged air leak

    Incidence of prolonged air leak (\>5 days) or requiring discharge with chest tube

    Through completion of follow-up (30 days)

  • Need for supplemental oxygen

    Incidence of patients requiring supplemental oxygen upon discharge

    Through completion of follow-up (30 days)

  • Empyema/bronchopleural fistula

    Incidence of empyema and/or bronchopleural fistula confirmed by fluid analysis and/or cultures

    Through completion of follow-up (30 days)

  • Cardiac arrhythmia

    Incidence of cardiac arrhythmia requiring intervention (e.g. atrial fibrillation, supraventricular tachycardia, etc.)

    Through completion of follow-up (30 days)

Secondary Outcomes (6)

  • Hospital length of stay

    Through completion of follow-up (30 days)

  • ICU length of stay

    Through completion of follow-up (30 days)

  • Chest tube duration

    Through completion of follow-up (30 days)

  • Hospital readmission

    Through completion of follow-up (30 days)

  • Change from baseline in dyspnea, measured by the modified Medical Research Council scale

    Baseline, 2 weeks and 4 weeks after surgery

  • +1 more secondary outcomes

Study Arms (2)

Incentive Spirometry

EXPERIMENTAL

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

Other: Inspiratory muscle training

Standard Care

NO INTERVENTION

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

Interventions

Inspiratory muscle trainingOTHER

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.

Also known as: Incentive spirometry
Incentive Spirometry

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (5)

  • Pehlivan E, Turna A, Gurses A, Gurses HN. The effects of preoperative short-term intense physical therapy in lung cancer patients: a randomized controlled trial. Ann Thorac Cardiovasc Surg. 2011;17(5):461-8. doi: 10.5761/atcs.oa.11.01663. Epub 2011 Jul 13.

    PMID: 21881371BACKGROUND

  • Gao K, Yu PM, Su JH, He CQ, Liu LX, Zhou YB, Pu Q, Che GW. Cardiopulmonary exercise testing screening and pre-operative pulmonary rehabilitation reduce postoperative complications and improve fast-track recovery after lung cancer surgery: A study for 342 cases. Thorac Cancer. 2015 Jul;6(4):443-9. doi: 10.1111/1759-7714.12199. Epub 2014 Dec 22.

    PMID: 26273399BACKGROUND

  • Valkenet K, Trappenburg JCA, Ruurda JP, Guinan EM, Reynolds JV, Nafteux P, Fontaine M, Rodrigo HE, van der Peet DL, Hania SW, Sosef MN, Willms J, Rosman C, Pieters H, Scheepers JJG, Faber T, Kouwenhoven EA, Tinselboer M, Rasanen J, Ryynanen H, Gosselink R, van Hillegersberg R, Backx FJG. Multicentre randomized clinical trial of inspiratory muscle training versus usual care before surgery for oesophageal cancer. Br J Surg. 2018 Apr;105(5):502-511. doi: 10.1002/bjs.10803.

    PMID: 29603130BACKGROUND

  • Weiner P, Man A, Weiner M, Rabner M, Waizman J, Magadle R, Zamir D, Greiff Y. The effect of incentive spirometry and inspiratory muscle training on pulmonary function after lung resection. J Thorac Cardiovasc Surg. 1997 Mar;113(3):552-7. doi: 10.1016/S0022-5223(97)70370-2.

    PMID: 9081102BACKGROUND

  • Benzo R, Wigle D, Novotny P, Wetzstein M, Nichols F, Shen RK, Cassivi S, Deschamps C. Preoperative pulmonary rehabilitation before lung cancer resection: results from two randomized studies. Lung Cancer. 2011 Dec;74(3):441-5. doi: 10.1016/j.lungcan.2011.05.011. Epub 2011 Jun 12.

    PMID: 21663994BACKGROUND

Study Officials

  • Pauline H Go, MD

    Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Surgery

Study Record Dates

First Submitted

January 27, 2021

First Posted

February 1, 2021

Study Start

April 27, 2021

Primary Completion

June 7, 2023

Study Completion

June 7, 2023

Last Updated

June 13, 2023

Record last verified: 2023-06

Locations

US(1)