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Completed

NCT Number: NCT02146092

Incentive Spirometry Added to Physiotherapy to Reduce Postoperative Pulmonary Complications After Lung Surgery

After any surgery, there is a chance of complications. After lung surgery to remove tumours, there is a particularly high chance of a person developing an infection or needing help breathing, called post operative pulmonary complications. Currently, the risk of these complications is reduced through the completion of light physical and deep breathing exercises and walking around as soon as possible after surgery. Another possible way of helping these patients is to use a small device called an Incentive Spirometer to encourage and measure deep breathing. This study wants to compare how often postoperative pulmonary complications happen after major lung surgery between a group completing the exercises alone and a group using the Incentive spirometer in addition to the exercises. It is hoped that the combined therapy will reduce the amount of time patient must stay in hospital, have fewer complication events and have fewer patients re-admitted back into the hospital after they go home, so that patients overall have better outcomes.

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Key information

Conditions

Lung Neoplasms Benign Lung Disease Lung Diseases Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

About this study

This study is a prospective blinded randomized control trial (RCT) where two arms will be assembled. Consenting eligible patients will be randomized to either the physiotherapy + incentive spirometry (PT+IS-intervention) arm or physiotherapy only (PT-control arm). Patients will be randomized with an equal (1:1) chance of being allocated to either the PT (control) arm or PT+IS (intervention) arm. Both the treating surgeon and data interpreter will be blinded to the intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must be at minimum age 18
  • Patient must be undergoing pulmonary resection surgery for malignant or benign disease
  • Patients must be able to understand English
  • Patients must be able to demonstrate aptitude and willingness to comply with describes study procedures

Exclusion criteria

  • Patients who are unable to read and communicate in English
  • Home oxygen usage prior to operation
  • Previous pulmonary resection or any thoracic surgery
  • Radiological evidence of atelectasis or pneumonitis on preoperative imaging
  • Radiological evidence of pleural effusion prior on preoperative imaging
  • Prior exposure to pulmonotoxic drugs such as amiodarone or belomycin
  • Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • Inability or unwillingness of individual or legal guardian/representative to give written informed consent

Treatment and study plan

Incentive spirometry

Procedure

Physiotherapy

Other

Standard of care exercise training and supervision

Primary outcomes

  1. Rate of post operative pulmonary complications within 30 days of surgery

    Time frame: 30 days after surgery

    Postoperative pulmonary complications (PPCs) are defined as:

    • Pneumonia requiring treatment with antibiotics
    • Atelectasis requiring pulmonary toilet by bronchoscopy
    • Respiratory failure requiring treatment via mechanical ventilation (invasive or non-invasive)
    • Requirement for home oxygen after surgery, when this was not the case prior to surgery

Secondary outcomes

  1. Duration of oxygen treatment in hospital

    Time frame: 30 days post-surgery

    Use of oxygen therapy required while in hospital

  2. Length of hospital stay

    Time frame: 30 days after surgery

  3. Re-admission to hospital

    Time frame: 30 days

    Re-admission to hospital due to post operative pulmonary complications

  4. Cost effectiveness of spirometry utilization

    Time frame: 30 days after surgery

    Calculated as an aggregate measure considering length of hospital stay, readmission to hospital and cost of treating complications. A cost value will be assigned to each group and compared for cost-benefit relationships

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • McMaster Surgical Associates

Registry information

Official study title

Incentive Spirometry Added to Physiotherapy to Reduce Postoperative Pulmonary Complications After Lung Surgery: A Prospective Blinded Randomized Trial

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 23, 2014
Registry last updated
Feb 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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