The Validity of Maximal Diaphragm Thickening Fraction to Measure Diaphragm Function in Mechanically Ventilated Patients

NCT ID: NCT03129217

Last Updated: 2020-08-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 29 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2020-04-30

Brief Summary

This study is designed to determine whether maximal diaphragm thickening fraction measured by ultrasound during volitional maximal inspiratory efforts is a valid measure of diaphragm function in mechanically ventilated patients.

Detailed Description

Classically, assessing diaphragm function requires direct measurements of transdaphragmatic pressure generation. A critical requirement for valid measurements is a maximal volitional patient effort. An alternative is to standardize the stimulus to the diaphragm using magnetic twitch stimulation fo the phrenic nerve. This is the gold standard technique for diaphragm function measurement in the respiratory physiology laboratory.

Twitch measurements require technical expertise and expensive equipment; this technique is therefore basically limited to the laboratory. Bedside ultrasonography has been proposed as a method for measuring diaphragm function by assessing the thickening of the muscle during a maximal inspiratory effort. In order to achieve a maximal volitional effort in mechanically ventilated patients, several methods may be employed: coached maximal efforts, coached sniffing, and transient airway occlusion to stimulate respiratory drive (Marini maneuver).

The investigators are evaluating the validity of diaphragm functional assessment using bedside ultrasound in combination with coached efforts/sniffing/Marini maneuver against the gold standard technique: twitch transdiaphragmatic pressure.

Conditions

Diaphragm Injury; Weaning Failure; Mechanical Ventilation Complication

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients weaning from mechanical ventilation

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Adult patients (≥ 18 years old) with acute respiratory failure receiving invasive mechanical ventilation via endotracheal tube or tracheostomy
• Patients who meet readiness-to-wean criteria (triggering the ventilator; FiO2 ≤ 50%; PEEP ≤ 8 cm H20; hemodynamic stability)

Exclusion Criteria

• Contraindication to phrenic nerve stimulation (chest tube; cardiac pacemaker or implanted defibrillator; cervical implants; use of neuromuscular blocking agents within the 24 hours preceding the first diaphragm assessment (with the exception of succinylcholine used during rapid-sequence induction of anaesthesia for intubation); cervical spine injury; known pregnancy)
• Patients experiencing an acute exacerbation of an obstructive lung disease (chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Ewan Goligher

Clinical Associate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ewan C Goligher, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

University Health Network

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

15-9644-AE

Identifier Type: -

Identifier Source: org_study_id