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| Name | Class |
|---|---|
| The Research Council of Norway | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weaning failure | Defined as the failure to pass a spontaneous breathing trial or the need for reintubation or death within 48 hours |
| |
| Weaning success | Defined as a successful spontaneous breathing trial and is not reintubated or dies in the first 48 hours after extubation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RESPINOR DXT | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy - number of patients with overall acceptable signal quality from predefined quality criteria | First SBT | |
| Safety - skin irritation severity | options 'no irritation', slight redness', 'red and moist tissue', 'granulation tissue', and 'infection leading to debridement' |
Inclusion Criteria:
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):
Exclusion Criteria:
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Patients under invasive mechanical ventilation in the intensive care unit
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| Name | Affiliation | Role |
|---|---|---|
| Alexandre Demoule, MD | Hôpital Universitaire Pitié Salpêtrière | Principal Investigator |
| Michele Umbrello, MD | Ospedale San Carlo Borromeo | Principal Investigator |
| Øyvind Skraastad, MD | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Saint-Antoine | Paris | Cedex 12 | 75571 | France | ||
| Hôpitaux Universitaires de Marseille - AP-HM |
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| Second minute of the first SBT |
| 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 |
| 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 |
| 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 |
| 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 |
| After first SBT, when removing the sensors |
| 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 |
| 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 |
| 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 |
| Marseille |
| Chem. Des Bourrely |
| 13015 |
| France |
| Centre Hospitalier Universitaire de Montpellier | Montpellier | Select One... | 34090 | France |
| Centre Hospitalier Universitaire d'Angers | Angers | France |
| Centre Hospitalier Saint Joseph Saint Luc | Lyon | France |
| Hôpital Universitaire Pitié Salpêtrière | Paris | France |
| Ospedale San Carlo Borromeo | Milan | Italy |
| Oslo University Hospital | Oslo | Norway |
| St. Olavs University Hospital | Trondheim | Norway |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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