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

NCT04696406 | Completed

• 1 other identifier: DXT-CS-005
• Study Type: observational
• Target: 193
• Locations: 3 countries
• Sites: 9

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.

Conditions

Respiratory Failure

Keywords

Diaphragm ultrasound; Diaphragm function; Mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• 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

• 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

• 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

• Confirm thresholds for DE to predict weaning outcome during the SBT for the whole sample.

  Second minute of the first SBT

Other Outcomes (5)

• 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

• Time spent on achieving good sensor placement

  During sensor attachment before the first SBT

Study Arms (2)

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

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

Interventions

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.

Weaning failure; Weaning success

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients under invasive mechanical ventilation in the intensive care unit

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Respinor AS: lead
• The Research Council of Norway: collaborator

Study Sites (9)

Hopital Saint-Antoine

Paris, Cedex 12, 75571, France

Location

Hôpitaux Universitaires de Marseille - AP-HM

Marseille, Chem. Des Bourrely, 13015, France

Location

Centre Hospitalier Universitaire de Montpellier

Montpellier, Select One..., 34090, France

Location

Centre Hospitalier Universitaire d'Angers

Angers, France

Location

Centre Hospitalier Saint Joseph Saint Luc

Lyon, France

Location

Hôpital Universitaire Pitié Salpêtrière

Paris, France

Location

Ospedale San Carlo Borromeo

Milan, Italy

Location

Oslo University Hospital

Oslo, Norway

Location

St. Olavs University Hospital

Trondheim, Norway

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 21 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: January 6, 2021
• Study Start: May 11, 2021
• Primary Completion: March 30, 2022
• Study Completion: April 30, 2022
• Last Updated: December 19, 2023

Record last verified: 2023-12

Locations

NO (2); FR (6); IT (1)