Acute Respiratory DiseasePoccUSNCT07564258

Estimation of P0.1 Using Ultrasound Indexes of Diaphragm Function

An observational study of Acute Respiratory Disease, run by Assistance Publique - Hôpitaux de Paris.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Respiratory Disease
What is being tested?: Spontaneous breathing trial
Type of treatment: Medical device
How many people: 40 participants
Where: No sites listed yet
Study dates: Sep 2026to Jan 2027
Phase: Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

- 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)

Who cannot join

- 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

About this study

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

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.

Conditions: Acute Respiratory Disease
Being tested: Spontaneous breathing trial
Keywords: acute respiratory failure, respiratory drive, P0.1, Airway occlusion pressure, Diaphragm, ultrasonography doppler

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Spontaneous breathing trialDevice
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 5 minutes after the initiation of the SBT

Secondary outcomes (8)

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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
Airway 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
Measured: 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
Airway 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
Measured: 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
Airway 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.
Measured: 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
Airway 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.
Measured: Immediately after the initiation of the SBT then 10, 15, 20, 25 and 30 minutes after the initiation of the SBT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2026Jan 2027

First posted4 May 2026
Study startSep 2026 (estimated)
Primary completionJan 2027 (estimated)
Study completionJan 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute Respiratory DiseaseStudies of the same condition, open and under way.
More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07564258
Sponsor's protocol ID: APHP260589
Acronym: PoccUS
Status last verified: Apr 2026
First submitted: 27 Apr 2026
Last updated: 25 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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