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Completed

NCT Number: NCT03129217

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Health Network

Toronto, Ontario, M5G 2N2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Primary outcomes

  1. Maximal diaphragm thickening fraction

    Time frame: On day of study

    Diaphragm ultrasound to measure thickening fraction

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Acronym: SNIFF III

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Apr 26, 2017
Registry last updated
Jun 23, 2026

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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