Clinical trial NCT04696406: Multicenter, Multinational, Clinical Trial of the Performance of RESPINOR DXT to Identify Patients at Increased Risk of Weaning Failure
Official title: Multicenter, Multinational, Clinical Trial of the Performance of RESPINOR DXT to Identify Patients at Increased Risk of Weaning Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Failure
Keywords: Diaphragm ultrasound
Diaphragm function
Mechanical ventilation
Lead sponsor: Respinor AS
Sponsor class: INDUSTRY
Collaborators: name: The Research Council of Norway
First posted: 2021-01-06
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients under invasive mechanical ventilation in the intensive care unit

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 breathing trial (SBT). Continuous diaphragmatic excursion measurements by DXT will be conducted during the patients' first SBT. The recording shall be initiated 15 minutes prior to the first SBT and will end 15 minutes post SBT.

All patients on mechanical ventilation in the ICU meeting the eligibility criteria shall undergo a daily screen for weaning readiness. If any of the components of the daily screen is not met, the patient will not undergo a SBT that day and continued to be screened daily. Patients passing daily screening criteria shall automatically receive an SBT.

The SBT shall last for 30-120 minutes and be performed on continuous positive airway pressure up to 5 cm H2O and pressure support up to 7 cm H2O. The SBT shall be terminated and mechanical ventilation reinstituted at the original settings if the patient meets any of the SBT failure criteria.

A trial is considered successful and physicians will be asked to approve extubation when the patient can breathe spontaneously for the whole trial.

Patients shall be continued to be screened daily until extubation, 21 days after enrolment, performance of tracheostomy, death, or withdrawal of care. All patients shall be followed until hospital discharge or death.


Eligibility criteria: Inclusion Criteria:

1. Patients willing and able to give informed consent (either themselves or next of kin)
2. Have undergone invasive mechanical ventilation \> 24 hours
3. Ready to wean according to criteria (from the sixth international consensus conference on intensive care medicine):

   1. Adequate cough
   2. Absence of excessive tracheobronchial secretion
   3. Resolution of disease acute phase for which the patient was intubated
   4. 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
   5. Adequate oxygenation, defined as SaO2 \> 90% on \< FIO2 0.4 (or PaO2/FIO2 \> 150 mmHg) and PEEP \< 8 cmH2O
   6. Adequate pulmonary function, i.e. fR \< 35 breaths·min-1
   7. 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 Criteria:

1. Not registered with a social security system nor entitled to be
2. Central or spinal neurological injury involving central ventilatory control
3. Presence of a neuromuscular disease involving respiratory muscles
4. Use of muscle-paralyzing agents within 24h before the study, except if given for intubation
5. 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
6. Tracheostomy
7. Body mass index \>35 kg/m2
8. Patient with therapeutic limitation, i.e. reduced expectancy to survive
9. Pregnant woman or protected adult

Primary outcomes:
measure: Difference in the rate of weaning failure between patients with a DE < 1.1 cm compared to those with a DE > 1.1 cm.
timeFrame: Second minute of the first SBT
Secondary outcomes:
measure: Difference in the rate of weaning failure with reintubation failure 72 hours and 7 days after extubation between patients with a DE <1.1 cm compared to those with a DE >1.1 cm.
timeFrame: Second minute of the first SBT
measure: Subgroup analysis on the difference in the rate of weaning failure between patients with a DE <1.1 cm compared to those with a DE >1.1 cm excluding COVID-19 patients. Similar subgroup analysis for COVID-19 patients.
timeFrame: Second minute of the first SBT
measure: Correlation between median DE measurements taken during the second minute of the SBT and duration of mechanical ventilation prior to the first SBT, after the SBT and total mechanical ventilation time.
timeFrame: Second minute of the first SBT
measure: Correlation between median DE measurements taken during the second minute of the SBT and duration of ICU stay prior to the first SBT, after the SBT and total ICU time.
timeFrame: Second minute of the first SBT
measure: Confirm thresholds for DE to predict weaning outcome during the SBT for the whole sample.
timeFrame: Second minute of the first SBT
Other outcomes:
measure: Efficacy - number of patients with overall acceptable signal quality from predefined quality criteria
timeFrame: First SBT
measure: Safety - skin irritation severity
timeFrame: After first SBT, when removing the sensors
measure: Time spent on achieving good sensor placement
timeFrame: During sensor attachment before the first SBT
measure: Safety - skin irritation frequency
timeFrame: After first SBT, when removing the sensors
measure: Criteria for the Earlier Termination of the Trial - sample size calculation based on weaning failure rate
timeFrame: When a minimum of 154 subjects have been enrolled (180 when accounting for dropouts), through study completion, assessed up to 1 year
Locations:
city: Paris
country: France
facility: Hopital Saint-Antoine
state: Cedex 12
city: Marseille
country: France
facility: Hôpitaux Universitaires de Marseille - AP-HM
state: Chem. Des Bourrely
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire de Montpellier
state: Select One...
city: Angers
country: France
facility: Centre Hospitalier Universitaire d'Angers
city: Lyon
country: France
facility: Centre Hospitalier Saint Joseph Saint Luc
city: Paris
country: France
facility: Hôpital Universitaire Pitié Salpêtrière
city: Milan
country: Italy
facility: Ospedale San Carlo Borromeo
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Trondheim
country: Norway
facility: St. Olavs University Hospital
Study officials:
affiliation: Hôpital Universitaire Pitié Salpêtrière
name: Alexandre Demoule, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale San Carlo Borromeo
name: Michele Umbrello, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital
name: Øyvind Skraastad, MD
role: PRINCIPAL_INVESTIGATOR
References: