Diaphragmatic Speckle Tracking During Spontaneous Breathing Trial

Mechanical Ventilation Clinical Trial

— DIAST  

Official title:

DIAPHRAGMATIC SPECKLE TRACKING DURING SPONTANEOUS BREATHING TRIAL

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06009731
• Other study ID #: PI2023_843_0040
• Status: Recruiting
• Start date: June 12, 2023
• Est. completion date: June 2025

Study information

• Verified date: July 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Clément Brault, MD
• Phone: 03 22 08 89 09
• Email: brault.clement[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Currently, measurement of transdiaphragmatic pressure (Pdi) using oesophageal and gastric balloons is the gold standard for the assessment of diaphragmatic effort. This technique is relatively invasive and its interpretation may be complex. The diaphragmatic longitudinal strain (LSdi) and strain rate (LSRdi) might provide additional information in the assessment of diaphragmatic effort and movement during SBT, allowing early detection of diaphragmatic dysfunction. Patients will be monitored during a 30-120 minutes SBT consisting of no assistance on the ventilator using CPAP with a pressure level of 0 cmH2O. Parameters to evaluate diaphragm function will include diaphragmatic strain (LSdi and LSRdi), diaphragmatic thickening fraction (TFdi), and airway occlusion pressure (ΔP0.1 and ΔPocc). These parameters will be measured immediately before ('baseline') the SBT, as well as 2 minutes ('early' assessment), 15 ('intermediate' assessment) and 30 minutes ('late' assessment) after the beginning of the SBT.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Consecutive adult patients (=18 years old) undergoing mechanical ventilation for at least 24h (regardless of the reason of intubation)
• patients fulfilling criteria for an SBT
• patients will have to be able to trigger ventilator breaths with a reasonable level of assistance,
• patients with lack of severe impairment in gas exchange,
• patients that not require significant hemodynamic support.
• Patients will be recruited by the study coordinator following completion of informed consent from the patient or legally authorized substitute decision maker.

Exclusion Criteria:

• Use of pressure support during the SBT.
• Severe hemodynamic instability (>30% increase in vasopressors in the last 6 hours or norepinephrine > 0.5 µg/kg/min).
• Severe or very severe chronic obstructive pulmonary disease (COPD) according to the GOLD criteria (stage III: FEV1 30-50% predicted; stage IV: FEV1 < 30% predicted).
• Known or suspected severe or progressive neuromuscular disorder likely to result in prolonged or chronic ventilator dependence
• Clinical judgement of the attending physician.

Related Conditions & MeSH terms

• Diaphragm
• Mechanical Ventilation
• Respiratory Aspiration
• Spontaneous Breathing Trial
• Strains
• Weaning

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes of diaphragmatic longitudinal strain between baseline and during Spontaneous breathing trial	diaphragmatic longitudinal strain is LSdi Spontaneous breathing trial is SBT	7 days
Primary	changes of diaphragmatic longitudinal strain strain rate between baseline and during Spontaneous breathing trial	diaphragmatic longitudinal strain strain rate is LSRdi Spontaneous breathing trial is SBT	7 days