NCT03747380

Brief Summary

Postoperative pulmonary complications are the most common complications after thoracic surgery. In the literature, pulmonary complications after thoracic surgery are present in more than 37.5% of patients. No study investigates the impact of preoperative inspiratory muscle exercises program on pulmonary complications after thoracic surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
141

participants targeted

Target at P50-P75 for not_applicable lung-cancer

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

September 13, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 7, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

1.8 years

First QC Date

September 13, 2018

Last Update Submit

February 14, 2023

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Numbers of postoperative pulmonary complications

    Up to 30 days after surgery

Secondary Outcomes (2)

  • Numbers of morbidity and mortality

    Up to 30 days after surgery

  • Length of stay (by days)

    Up to 30 days after surgery

Study Arms (2)

inspiratory muscle program

EXPERIMENTAL

Inspiratory muscle training preoperative with standard of care

Other: inspiratory muscle program

no inspiratory muscle program

OTHER

standard of care: postoperative spirometry with enhanced recovery program in thoracic surgery

Other: inspiratory muscle program

Interventions

inspiratory muscle programOTHER

pre-operative inspiratory muscular training program

inspiratory muscle programno inspiratory muscle program

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to consent
  • Pulmonary resection: segmental resection or lobectomy or bilobectomy
  • With or without previous pulmonary resection
  • Thoracotomy and minimally invasive surgery
  • With or without neoadjuvant chemotherapy
  • or more risk factors for pulmonary complications (over 70 years, cough and sputum, diabetes, smoking, FEV1 less than 75% or under pump, BMI over 27 kg / m2, FEV1 less than 80%, TIFF less than 70%, NYHA II or sleep apnea)

You may not qualify if:

  • Refusal of the patient
  • Pregnancy
  • Pneumonectomy
  • FEV1 less than 30%
  • DLCO less than 30%
  • Vo2 MAX less than 10cc / min / kg
  • Contraindication to respiratory physiotherapy - Myocardial infarction or cerebrovascular accident for less than 1 year, unstable angina, aneurysm, significant hemoptysis less than 90 days, muscular or neurological pathology constraining respiratory physiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUM

Montreal, Quebec, H2X3E4, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Moishe Liberman, MD, PhD

    CHUM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2018

First Posted

November 20, 2018

Study Start

January 7, 2019

Primary Completion

October 31, 2020

Study Completion

October 31, 2022

Last Updated

February 15, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)