Neonatal Diaphragmatic Activity-Linked Extubation Conditions and Timing

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-3
SponsorCentre Hospitalier Intercommunal Creteil

About this trial

The objective of this study is to evaluate the role of diaphragmatic electrical activity monitoring (collected by esophageal probe) around extubation of preterm patients in order to consider its use as a standardized objective criterion to aid in the decision to extubate.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All newborns born at <32 weeks of amenorrhea hospitalized in the neonatal intensive care unit at CHIC

Patient intubated and ventialted with an Edi tube in place

Patient eligible for scheduled extubation

Disqualifiers

Absence of Edi tube

Palliative care situation

Patient treated with curare

Patients with neuromuscular disorders

Trial population

Patients admitted to the neonatal intensive care unit at the Creteil Intercommunal Hospital Center

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

20 Participants
are grouped into 1 trial group
Group A: Patients of neonatal intensive care unit

Trial outcomes

Primary outcomes

1

Extubation success

Comparaison with patients who experience extubation failure. Focusing on clinical, therapeutic, and ventilatory data. In particular data extracted by the servo-tracker software (collected from the time the software is installed on the ventilator following the decision to extubate until the actual extubation): * Maximum, minimum, and average EDI over the period * Tidal volume: maximum, minimum, and average over the period * Inspiratory time: maximum, minimum, and average over the period * Total time between the decision to extubate and the actual extubation This data will be used to calculate: * Neuro-mechanical efficiency: Mean tidal volume / Mean EDI max * Variability of the EDI max signal: its standard deviation * Respiratory variability: standard deviation of tidal volume

Time frame
7 days

Secondary outcomes

1

Time to reintubation

Duration between extubation and reintubation

Time frame
7 days
2

Reintubation rate

Ratio of the number of patients who were reintubated to the total population

Time frame
7 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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