Health TrialsbyHealthPanel

Estimation of P0.1 Using Ultrasound Indexes of Diaphragm Function

ConditionAcute Respiratory Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

- 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)

Disqualifiers

- Suspicion of diaphragmatic nerves injury

Preexisting neuromuscular disease

Spinal cord injury above C5

Neuromuscular blockade within last 24 hours

Trial population

Patients admitted to the intensive care unit who are intubated or have undergone a tracheostomy.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Spontaneous breathing trial

    Device

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

P0.1 and Peak contraction velocity 5 minutes after the initiation of the SBT

Airway occlusion pressure measured 100 ms after the initiation of the inspiration, compared to peak contraction velocity of the diaphragm, measured by subcostal ultrasound in TDI-mode

Time frame
5 minutes after the initiation of the SBT

Secondary outcomes

1

P0.1 and EXdi

Airway occlusion pressure measured 100 ms after the initiation of the inspiration, compared to maximal excursion of the diaphragm, measured by subcostal ultrasound in M-mode

Time frame
Immediately after the initiation of the SBT then 5, 10, 15, 20, 25 and 30 minutes after the initiation of the SBT
2

P0.1 and Peak contraction velocity

Airway occlusion pressure measured 100 ms after the initiation of the inspiration, compared to peak contraction velocity of the diaphragm, measured by subcostal ultrasound in TDI-mode

Time frame
Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT
3

P0.1 and EXdi,0.1

Airway occlusion pressure measured 100 ms after the initiation of the inspiration, compared to excursion of the diaphragm measured 100 ms after the beginning of the inspiration, measured by subcostal ultrasound in M-mode

Time frame
Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT
4

P0.1 and Velocity Time Integral

Airway occlusion pressure measured 100 ms after the initiation of the inspiration, compared to velocity time integral of the diaphragm, measured by subcostal ultrasound in TDI-mode

Time frame
Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: