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

Respiratory Failure Clinical Trial

— DE-RISK WF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04696406
• Other study ID #: DXT-CS-005
• Status: Completed
• Start date: May 11, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: December 2023
• Source: Respinor AS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: April 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• RESPINOR DXT
Blinded, 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.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire d'Angers	Angers
France	Centre Hospitalier Saint Joseph Saint Luc	Lyon
France	Hôpitaux Universitaires de Marseille - AP-HM	Marseille	Chem. Des Bourrely
France	Centre Hospitalier Universitaire de Montpellier	Montpellier	Select One...
France	Hopital Saint-Antoine	Paris	Cedex 12
France	Hôpital Universitaire Pitié Salpêtrière	Paris
Italy	Ospedale San Carlo Borromeo	Milan
Norway	Oslo University Hospital	Oslo
Norway	St. Olavs University Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Respinor AS	The Research Council of Norway

Countries where clinical trial is conducted

France,  Italy,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Efficacy - number of patients with overall acceptable signal quality from predefined quality criteria		First SBT
Other	Safety - skin irritation severity	options 'no irritation', slight redness', 'red and moist tissue', 'granulation tissue', and 'infection leading to debridement'	After first SBT, when removing the sensors
Other	Time spent on achieving good sensor placement	with options 0-5, 6-10 mins, 11-20 mins, 21-30 mins, > 30 mins	During sensor attachment before the first SBT
Other	Safety - skin irritation frequency	Frequency of skin irritation presented in percentage for each category of skin irritation severity	After first SBT, when removing the sensors
Other	Criteria for the Earlier Termination of the Trial - sample size calculation based on weaning failure rate	Sample size have been calculated with the basis of 4 main assumptions: proportion of weaning failure, assumed relative risk (RR), level of significance, and power. Of these, the proportion of weaning failure is independent of the outcome. Weaning failure rate was assumed to be 20%, requiring 218 patients to meet the endpoints (250 patients accounting for dropouts). If the observed weaning failure is 25%, the number of patients needed is 154 under the same assumptions. One interim assessment of study progress will be conducted. If the observed total proportion of weaning failure is 25% or above (only using the eCRF data, still blinded to the output from DXT), the Sponsor and Principal Investigator can recommend that the trial be concluded and analyzed according to the statistical analysis plan. The interim assessment will be conducted by calculating a 95% CI for the overall weaning failure. The CI will be calculated using the standard normal approximation for one sample proportions.	When a minimum of 154 subjects have been enrolled (180 when accounting for dropouts), through study completion, assessed up to 1 year
Primary	Difference in the rate of weaning failure between patients with a DE < 1.1 cm compared to those with a DE > 1.1 cm.	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.	Second minute of the first SBT
Secondary	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.	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.	Second minute of the first SBT
Secondary	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.	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.	Second minute of the first SBT
Secondary	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.	Plots of DE values versus MV duration will be presented, together with the estimated correlation coefficient.	Second minute of the first SBT
Secondary	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.	Plots of DE values versus ICU duration will be presented, together with the estimated correlation coefficient.	Second minute of the first SBT
Secondary	Confirm thresholds for DE to predict weaning outcome during the SBT for the whole sample.	Thresholds for continuous DE will be defined by ROC curve analysis.	Second minute of the first SBT