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Not yet recruiting NCT07564258

Estimation of P0.1 Using Ultrasound Indexes of Diaphragm Function

— Observational Acute Respiratory Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Spontaneous breathing trial.
Who it may be relevant to
Registry conditions: Acute Respiratory Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Estimation of Airway Occlusion Pressure at 100 ms Using Ultrasound Indexes of Diaphragm Function

Overview

Occlusion pressure at 100 ms (P0.1) is a reliable and non-invasive index of inspiratory drive that can be measured easily on most ventilator. Unfortunately, P0.1 cannot be measured reliably in non-intubated patients. In those receiving non-invasive ventilation, the measurement of P0.1 might be inaccurate due to leaks. P0.1 cannot be measured at all in patients receiving high-flow nasal canulae (HFNC). Ultrasound indices of diaphragm contractile function, namely diaphragm excursion, velocity and thickening fraction, could be reliable and non-invasive proxies of respiratory drive in non-intubated patient. Our hypothesis is that ultrasound indices of diaphragm function may reliably estimate P0.1. To validate this hypothesis, theses indices will be measured simultaneously with P0.1 in intubated patients, during diaphragm loading conditions similar to spontaneous breathing: the spontaneous breathing trial (SBT). The SBT is used to evaluate if patients can breathe without the assistance provided by the ventilator, and thus, be weaned from mechanical ventilation.

Interventions

  • Device Spontaneous breathing trial
    A plateau pressure measurement will be performed before starting the spontaneous breathing trial (SBT). Then, immediately and 5, 10, 15, 20, 25, and 30 minutes after the start of the SBT, the following will be performed as part of the study: * Subcostal diaphragmatic ultrasound: M-mode and tissue Doppler * Lateral diaphragmatic ultrasound: 2D mode and M-mode * Measurement of P0.1 * Measurement of Pocc during a tele-expiratory pause, only 5 minutes after the start of the SBT.

Primary outcome measures

  • P0.1 and Peak contraction velocity 5 minutes after the initiation of the SBT [Time frame: 5 minutes after the initiation of the SBT]
Secondary outcome measures (8)
  • P0.1 and EXdi [Time frame: Immediately after the initiation of the SBT then 5, 10, 15, 20, 25 and 30 minutes after the initiation of the SBT]
  • P0.1 and Peak contraction velocity [Time frame: Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT]
  • P0.1 and EXdi,0.1 [Time frame: Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT]
  • P0.1 and Velocity Time Integral [Time frame: Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT]
  • P0.1 and Peak relaxation velocity [Time frame: Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT]
  • P0.1 and Peak relaxation rate [Time frame: Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT]
  • P0.1 and TFdi [Time frame: Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT]
  • P0.1 and mean thickening velocity [Time frame: Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT]

Eligibility criteria

Inclusion criteria

  • \- Age ≥ 18 years old
  • Patient intubated or tracheostomized
  • Decision by the clinician in charge to initiate a SBT
  • After information, the patient or next of kind did not refuse to participate (according to the French law, written informed consent is waived)

Exclusion criteria

  • \- Suspicion of diaphragmatic nerves injury
  • Preexisting neuromuscular disease
  • Spinal cord injury above C5
  • Neuromuscular blockade within last 24 hours
  • Body mass index > 40 kg/m2
  • Pregnancy or breast feeding
  • Patient under legal protection

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07564258 · APHP260589

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗