Status:
COMPLETED
Multicenter, Multinational, Clinical Trial of the Performance of RESPINOR DXT to Identify Patients at Increased Risk of Weaning Failure
Lead Sponsor:
Respinor AS
Collaborating Sponsors:
The Research Council of Norway
Conditions:
Respiratory Failure
Eligibility:
All Genders
18+ years
Brief Summary
The study will be a multicenter, multinational, prospective single arm blinded study to validate DXT's performance to identify patients at increased risk of weaning failure during the spontaneous brea...
Eligibility Criteria
Inclusion
- Patients willing and able to give informed consent (either themselves or next of kin)
- Have undergone invasive mechanical ventilation \> 24 hours
- Ready to wean according to criteria (from the sixth international consensus conference on intensive care medicine):
- Adequate cough
- Absence of excessive tracheobronchial secretion
- Resolution of disease acute phase for which the patient was intubated
- Clinical stability, defined as stable cardiovascular status (i.e. fC \< 140 beats·min-1, systolic BP 90-160 mmHg, no or minimal vasopressors) and stable metabolic status
- Adequate oxygenation, defined as SaO2 \> 90% on \< FIO2 0.4 (or PaO2/FIO2 \> 150 mmHg) and PEEP \< 8 cmH2O
- Adequate pulmonary function, i.e. fR \< 35 breaths·min-1
- Adequate mentation, defined as no sedation or adequate mentation on sedation (or stable neurologic patient), i.e., patient awake, calm and responsive to simple orders (squeeze hand, knock the head, close the eyes), no agitation.
Exclusion
- Not registered with a social security system nor entitled to be
- Central or spinal neurological injury involving central ventilatory control
- Presence of a neuromuscular disease involving respiratory muscles
- Use of muscle-paralyzing agents within 24h before the study, except if given for intubation
- Known paralysis of a hemidiaphragm or suspicion of paralysis of a hemidiaphragm, defined by the radiographic evidence of elevation of a dome \> 2.5 cm compared to the contralateral dome
- Tracheostomy
- Body mass index \>35 kg/m2
- Patient with therapeutic limitation, i.e. reduced expectancy to survive
- Pregnant woman or protected adult
Key Trial Info
Start Date :
May 11 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 30 2022
Estimated Enrollment :
193 Patients enrolled
Trial Details
Trial ID
NCT04696406
Start Date
May 11 2021
End Date
April 30 2022
Last Update
December 19 2023
Active Locations (9)
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1
Hopital Saint-Antoine
Paris, Cedex 12, France, 75571
2
Hôpitaux Universitaires de Marseille - AP-HM
Marseille, Chem. Des Bourrely, France, 13015
3
Centre Hospitalier Universitaire de Montpellier
Montpellier, Select One..., France, 34090
4
Centre Hospitalier Universitaire d'Angers
Angers, France