Use of Transient Elastogaphy to Assess Diaphragm Function in Mechanically Ventilated Patients

NCT03832231 | Completed

• 2 other identifiers: APHP1802642018-A02311-54
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Mechanical ventilation is a life-saving treatment that can be associated with diaphragm dysfunction, a potentially deleterious acquired disability. It may be the consequence of disuse - under mechanical ventilation, respiratory muscles are unloaded - or the consequence of muscle overuse because of insufficient unloading. Evaluating diaphragm function is therefore crucial to optimally tailor the ventilator assistance. Measurement of transdiaphragmatic pressure (Pdi) is the reference method to assess diaphragm function but it invasiveness hinders the generalization of its use. Previous studies have reported that ultrasound can quantify diaphragm thickening and that diaphragm thickening fraction (TFdi) is a good marker of diaphragm function. Since diaphragm becomes stiffer when it contracts, the investigators aim at exploring whether the measurement of diaphragm stiffness by transient shear wave elastography would improve the evaluation of diaphragm function with ultrasound. Therefore, the objectives of the study are to evaluate the performance of transient shear wave elastography applied to the diaphragm to estimate Pdi in mechanically ventilated patients as compared to TFdi and to correlate the changes in elastography derived indices, in TFdi and in Pdi into different ventilatory conditions and during a spontaneous breathing trial. Pdi will be obtained using catheters positioned in patients' stomachs and esophagus and diaphragm stiffness will be assessed by measuring the shear modulus of the diaphragm with a dedicated ultrasound machine (Aixplorer, Ultrasonic). TFdi will be also measured as previously reported. Pdi, TFdi and shear modulus will be measured at the end of each four following 10 minutes-conditions: 1) baseline with initial ventilator settings (set by the physician in charge of patient); 2) 25%-increase in pressure support and initial PEEP; 3) 25%-decrease in pressure support and initial PEEP and 4) initial level of pressure support and ZEEP. Finally, the same measurements will be done at the beginning of a 30 minutes spontaneous breathing trial.

Conditions

Ventilator Weaning; Intensive Care Unit

Keywords

Shear wave elastography; Ultrasonography; Transdiaphragmatic pressure; Diaphragmatic function; Mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Change in transdiaphragmatic pressure

  Reference method to assess diaphragm function computed as the difference between esophageal pressure and gastric pressure

  Through patient participation, an average of 1 day

Secondary Outcomes (3)

• Change in diaphragm thickness and thickening as expressed by the thickening fraction (ratio of the difference between inspiratory and expiratory thickness over expiratory thickness).

  Through patient participation, an average of 1 day

• Change in diaphragm stiffness

  Through patient participation, an average of 1 day

• Success or failure at the spontaneous breathing trial

  Through patient participation, an average of 1 day

Study Arms (1)

Ventilator liberating trial

EXPERIMENTAL

The diaphragmatic function of patients undergoing a ventilator liberating trial will be determined with transient shear wave elastography.

Device: Shear Wave Elastography

Interventions

Shear Wave Elastography DEVICE

Ultrasound technology to assess tissue stiffness

Ventilator liberating trial

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years old
• Intubation and mechanical ventilation since 24 hours
• Failure to a first ventilator liberating trial
• nasogastric feeding tube in place
• readiness criteria to undertake a ventilator liberating trial (Boles et al. ERJ 2007)
• patient written consent or next of kin written consent in case of physical inability of the patient to sign the consent form
• french social Health Service registration

You may not qualify if:

• pregnancy
• protective administrative control
• patient's refusal
• contra indications to the insertion of esophageal and gastric balloons
• allergy to topical anesthetic
• impossible weaning (full dependance to mechanical ventilation)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Groupe Hospitalier Pitié-Salpétrière

Paris, 75013, France

Location

Related Publications (1)

• Fosse Q, Poulard T, Nierat MC, Virolle S, Morawiec E, Hogrel JY, Similowski T, Demoule A, Gennisson JL, Bachasson D, Dres M. Ultrasound shear wave elastography for assessing diaphragm function in mechanically ventilated patients: a breath-by-breath analysis. Crit Care. 2020 Nov 27;24(1):669. doi: 10.1186/s13054-020-03338-y.

  PMID: 33246478 DERIVED

Study Officials

• Martin DRES, MD, PhD

  Assistance Publique Hoptiaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: February 6, 2019
• Study Start: February 14, 2019
• Primary Completion: February 15, 2019
• Study Completion: July 9, 2020
• Last Updated: March 1, 2021

Record last verified: 2021-02

Locations

FR (1)