Multicenter, Multinational, Clinical Trial of the Performance of RESPINOR DXT to Identify Patients at Increased Risk of Weaning Failure

Completed

• Conditions: Respiratory Failure
• Interventions: Device: RESPINOR DXT

• Registration Number: NCT04696406
• Lead Sponsor: Respinor AS

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-23
• Study First Submitted QC: 2021-01-04
• Study First Posted: 2021-01-06
• Study Start: 2021-05-11
• Primary Completion: 2022-03-30
• Study Completion: 2022-04-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 193

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Weaning success	RESPINOR DXT	Defined as a successful spontaneous breathing trial and is not reintubated or dies in the first 48 hours after extubation.
Weaning failure	RESPINOR DXT	Defined as the failure to pass a spontaneous breathing trial or the need for reintubation or death within 48 hours

Primary Outcome Measures

Name	Time	Method
Difference in the rate of weaning failure between patients with a DE < 1.1 cm compared to those with a DE > 1.1 cm.	Second minute of the first SBT	Median DE measurements taken during the second minute of the SBT will be used in the analysis. The hypothesis is that patients with DE \< 1.1 cm will have significantly higher rate of weaning failure compared to those with a DE \> 1.1 cm. The relative risk (RR) statistic will be used to assess the null hypothesis of equality.

Secondary Outcome Measures

Name	Time	Method
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.	Second minute of the first SBT	Median DE measurements taken during the second minute of the SBT will be used in the analysis. The hypothesis is that patients with DE \< 1.1 cm will have significantly higher rate of weaning failure compared to those with a DE \> 1.1 cm. The relative risk (RR) statistic will be used to assess the null hypothesis of equality.
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.	Second minute of the first SBT	Median DE measurements taken during the second minute of the SBT will be used in the analysis. The hypothesis is that patients with DE \< 1.1 cm will have significantly higher rate of weaning failure compared to those with a DE \> 1.1 cm. The relative risk (RR) statistic will be used to assess the null hypothesis of equality.
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.	Second minute of the first SBT	Plots of DE values versus MV duration will be presented, together with the estimated correlation coefficient.
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.	Second minute of the first SBT	Plots of DE values versus ICU duration will be presented, together with the estimated correlation coefficient.
Confirm thresholds for DE to predict weaning outcome during the SBT for the whole sample.	Second minute of the first SBT	Thresholds for continuous DE will be defined by ROC curve analysis.

Trial Locations

Locations (9)

Centre Hospitalier Universitaire de Montpellier; 🇫🇷 Montpellier, Select One..., France

Ospedale San Carlo Borromeo; 🇮🇹 Milan, Italy

Hopital Saint-Antoine; 🇫🇷 Paris, Cedex 12, France

Hôpitaux Universitaires de Marseille - AP-HM; 🇫🇷 Marseille, Chem. Des Bourrely, France

Hôpital Universitaire Pitié Salpêtrière; 🇫🇷 Paris, France

Centre Hospitalier Universitaire d'Angers; 🇫🇷 Angers, France

Centre Hospitalier Saint Joseph Saint Luc; 🇫🇷 Lyon, France

Oslo University Hospital; 🇳🇴 Oslo, Norway

St. Olavs University Hospital; 🇳🇴 Trondheim, Norway