DE-RISK WF: Multicenter, Multinational, Clinical Trial of the Performance of RESPINOR DXT to Identify Patients at Increased Risk of Weaning Failure
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Weaning failure Defined as the failure to pass a spontaneous breathing trial or the need for reintubation or death within 48 hours |
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.
|
| Weaning success Defined as a successful spontaneous breathing trial and is not reintubated or dies in the first 48 hours after extubation. |
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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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.
- 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.
Other Outcome Measures
- Efficacy - number of patients with overall acceptable signal quality from predefined quality criteria [First SBT]
- Safety - skin irritation severity [After first SBT, when removing the sensors]
options 'no irritation', slight redness', 'red and moist tissue', 'granulation tissue', and 'infection leading to debridement'
- Time spent on achieving good sensor placement [During sensor attachment before the first SBT]
with options 0-5, 6-10 mins, 11-20 mins, 21-30 mins, > 30 mins
- Safety - skin irritation frequency [After first SBT, when removing the sensors]
Frequency of skin irritation presented in percentage for each category of skin irritation severity
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients willing and able to give informed consent (either themselves or next of kin)
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Have undergone invasive mechanical ventilation > 24 hours
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Ready to wean according to criteria (from the sixth international consensus conference on intensive care medicine):
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Adequate cough
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Absence of excessive tracheobronchial secretion
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Resolution of disease acute phase for which the patient was intubated
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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
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Adequate oxygenation, defined as SaO2 > 90% on < FIO2 0.4 (or PaO2/FIO2 > 150 mmHg) and PEEP < 8 cmH2O
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Adequate pulmonary function, i.e. fR < 35 breaths·min-1
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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:
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Not registered with a social security system nor entitled to be
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Central or spinal neurological injury involving central ventilatory control
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Presence of a neuromuscular disease involving respiratory muscles
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Use of muscle-paralyzing agents within 24h before the study, except if given for intubation
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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
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Tracheostomy
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Body mass index >35 kg/m2
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Patient with therapeutic limitation, i.e. reduced expectancy to survive
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Pregnant woman or protected adult
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Hospitalier Universitaire de Montpellier | Montpellier | Select One... | France | 34090 |
| 2 | Centre Hospitalier Universitaire d'Angers | Angers | France | ||
| 3 | Centre Hospitalier Saint Joseph Saint Luc | Lyon | France | ||
| 4 | Hôpital Universitaire Pitié Salpêtrière | Paris | France | ||
| 5 | Ospedale San Carlo Borromeo | Milan | Italy | ||
| 6 | Oslo University Hospital | Oslo | Norway | ||
| 7 | St. Olavs University Hospital | Trondheim | Norway |
Sponsors and Collaborators
- Respinor AS
- The Research Council of Norway
Investigators
- Principal Investigator: Alexandre Demoule, MD, Hôpital Universitaire Pitié Salpêtrière
- Principal Investigator: Michele Umbrello, MD, Ospedale San Carlo Borromeo
- Principal Investigator: Øyvind Skraastad, MD, Oslo University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DXT-CS-005