Respiratory Muscle Structure and Function in Mechanically Ventilated Patients and Long-term Outcomes

NCT05857774 | Recruiting

• 1 other identifier: 22-5875
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

Air is normally pumped in and out of the lungs by the muscles that contribute to inhalation and exhalation, called the respiratory muscles. The abdominal muscles help by forcing air out of your lungs during exhalation; whereas the diaphragm, the main muscle used for breathing, contracts to get air into the lungs during inhalation. With mechanical ventilation, respiratory muscles are able to rest and recover while the breathing machine takes over; however, this may cause respiratory muscle weakness. Patients who develop weakness of these muscles may require more assistance from the ventilator and take longer to recover their ability to breathe without assistance. The impact of this phenomenon on long-term outcomes is uncertain. The RESPIRE study is designed to characterize how respiratory muscles change during mechanical ventilation and to evaluate the impact on long term quality of life. An additional objective of this study is to examine novel measures obtained from automated functions of a ventilator, that may better predict success from weaning from mechanical ventilation.

Conditions

Mechanical Ventilation Complication; Diaphragm Injury; Lung Injury; Respiratory Insufficiency; Abdominal Muscle Strained

Outcome Measures

Primary Outcomes (2)

• Quality of life at home

  5-level EQ-5D (EQ-5D-5L) score - The EQ-5D-5L is a validated self-reported instrument assessing quality of life at the moment questionnaire is completed. Each question is scored from 1 (no problems) to 5 (inability to perform activity) and are independently assessed.

  Day 180

• Quality of life at home

  Montreal Cognitive Assessment (MOCA) score - MoCA is a clinician-reported measure to assess for cognitive impairments. MoCA is scored out of 30 with scores \<26 indicating cognitive impairment.

  Day 180

Secondary Outcomes (10)

• Duration of ventilation

  Until hospital discharge (up to 6 months)

• Muscle research council score

  Until day 14

• Airway occlusion pressure (P0.1)

  First spontaneous breathing trial (within 5 minutes of onset)

• Expiratory occlusion pressure (Pocc)

  First spontaneous breathing trial (within 5 minutes of onset)

• Maximal inspiratory pressure (MIP)

  First spontaneous breathing trial within 30 minutes of onset

Study Arms (3)

Cases

Adult patients ≥18 years of age undergoing invasive mechanical ventilation in the ICU for any reason within 36 hours of intubation

Other: Sonographic measurements; Other: Physiological measurements; Other: Biological measurements

Control condition A

Non-invasively ventilated patients in the ICU within 36 hours of initiating non-invasive ventilation

Other: Sonographic measurements; Other: Physiological measurements; Other: Biological measurements

Control condition B

Non-ventilated patients admitted to the ICU receiving no respiratory support or oxygen therapy alone, including high flow nasal cannula

Other: Sonographic measurements; Other: Physiological measurements; Other: Biological measurements

Interventions

Sonographic measurements OTHER

Diaphragm thickness, diaphragm tidal thickening fraction, abdominal muscle thickness, rectus femoris cross-sectional area, maximal diaphragm thickening fraction, abdominal muscle thickening fraction

Cases; Control condition A; Control condition B

Physiological measurements OTHER

Airway occlusion pressure, maximal inspiratory pressure, muscle research council score

Cases; Control condition A; Control condition B

Biological measurements OTHER

Skeletal troponin-I

Cases; Control condition A; Control condition B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be enrolled in the Medical-Surgical ICU at Toronto General Hospital.

You may qualify if:

• Adult patients ≥18 years of age undergoing invasive mechanical ventilation in the ICU for any reason within 36 hours of intubation
• Non-invasively ventilated patients in the ICU within 36 hours of initiating non-invasive ventilation
• Non-ventilated patients admitted to the ICU receiving no respiratory support or oxygen therapy alone, including high flow nasal cannula

You may not qualify if:

• Patients expected to be extubated within 24 hours of screening for eligibility
• Patients who have already undergone a SBT at time of screening
• Patients with a previously diagnosed neuromuscular disorder
• Patients receiving long-term invasive mechanical ventilation (prior to current hospitalization)
• Patients who have required previously (during current hospitalization) a period of invasive ventilation in ICU of more than 24 hours
• Patients who have previously been enrolled in the study
• Patients for whom post-hospital follow-up may be challenging, e.g. those who reside overseas or who have no fixed address

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Skeletal Troponin-I

MeSH Terms

Conditions

Lung Injury; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries; Respiration Disorders

Study Officials

• Ewan Goligher, MD, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rongyu (Cindy) Jin

CONTACT

4163404800; rongyu.jin@uhn.ca

Catherine Bellissimo, PhD

CONTACT

catherine.bellissimo@uhn.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: May 15, 2023
• Study Start: April 27, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)