Diaphragmatic Speckle Tracking During Spontaneous Breathing Trial

NCT06009731 | Unknown

• 1 other identifier: PI2023_843_0040
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Weaning; Spontaneous Breathing Trial; Mechanical Ventilation; Speckle Tracking; Strains; Diaphragm

Keywords

weaning; spontaneous breathing trial; mechanical ventilation; speckle tracking; Strains; diaphragm

Outcome Measures

Primary Outcomes (2)

• changes of diaphragmatic longitudinal strain between baseline and during Spontaneous breathing trial

  diaphragmatic longitudinal strain is LSdi Spontaneous breathing trial is SBT

  7 days

• 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

Study Arms (1)

adult patients undergoing mechanical ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive adult patients (≥18 years old) undergoing mechanical ventilation for at least 24h (regardless of the reason of intubation) and fulfilling criteria for an SBT will be included in the study. Briefly, to be eligible for an SBT, patients will have to (i) be able to trigger ventilator breaths with a reasonable level of assistance, (ii) lack of severe impairment in gas exchange, and (iii) 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

MeSH Terms

Conditions

Sprains and Strains

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Clément Brault, MD

CONTACT

03 22 08 89 09; brault.clement@chu-amiens.fr

Study Design

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

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: August 24, 2023
• Study Start: June 12, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)