Skip to content

Estimation of P0.1 Using Ultrasound Indexes of Diaphragm Function

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07564258
Acronym
PoccUS
Enrollment
40
Registered
2026-05-04
Start date
2026-09-01
Completion date
2027-01-01
Last updated
2026-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Disease

Keywords

acute respiratory failure, respiratory drive, P0.1, Airway occlusion pressure, Diaphragm, ultrasonography doppler

Brief summary

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

DEVICESpontaneous 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.

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
P0.1 and Peak contraction velocity 5 minutes after the initiation of the SBT5 minutes after the initiation of the SBTAirway 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

Secondary

MeasureTime frameDescription
P0.1 and EXdiImmediately after the initiation of the SBT then 5, 10, 15, 20, 25 and 30 minutes after the initiation of the SBTAirway 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
P0.1 and Peak contraction velocityImmediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBTAirway 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
P0.1 and EXdi,0.1Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBTAirway 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
P0.1 and Velocity Time IntegralImmediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBTAirway 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
P0.1 and Peak relaxation velocityImmediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBTAirway occlusion pressure measured 100 ms after the initiation of the inspiration, compared to peak relaxation velocity of the diaphragm, measured by subcostal ultrasound in TDI-mode
P0.1 and Peak relaxation rateImmediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBTAirway occlusion pressure measured 100 ms after the initiation of the inspiration, compared to peak relaxation rate of the diaphragm, measured by subcostal ultrasound in TDI-mode
P0.1 and TFdiImmediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBTAirway occlusion pressure measured 100 ms after the initiation of the inspiration, compared to thickening fraction of the diaphragm, measured by intercostal ultrasound in M-mode.
P0.1 and mean thickening velocityImmediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBTAirway occlusion pressure measured 100 ms after the initiation of the inspiration, compared to mean thickening velocity of the diaphragm, measured by intercostal ultrasound in M-mode.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 26, 2026