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

NCT05580185 | Completed

• 1 other identifier: DXT-CS-007
• Study Type: observational
• Target: 145
• Locations: 2 countries
• Sites: 8

Brief Summary

The study will be a multicenter, multinational, prospective single arm blinded non-interventional follow-up study (from DXT-CS-005) to validate RESPINOR DXT's performance to identify patients at increased risk of weaning failure during the spontaneous breathing trial (SBT). Continuous diaphragmatic excursion measurements by RESPINOR 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. As part of the clinical investigation, patients shall be continued to be screened daily until extubation, 21 days after enrollment, the 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 < 1.0 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 \< 1.0 cm will have significantly higher rate of weaning failure compared to those with a DE \> 1.1 cm. The relative risk (RelR) statistic will be used to assess the null hypothesis of equality.

  Second minute of the SBT

Secondary Outcomes (9)

• Difference in the rate of weaning failure with reintubation failure 72 hours and 7 days after extubation between patients with a DE <1.0 cm compared to those with a DE >1.1 cm

  DE values from second minute of the SBT, follow for reintubation up to 7 days

• Subgroup analysis on the difference in the rate of weaning failure between patients with a DE <1.0 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 SBT

• Subgroup analysis on the difference in the rate of weaning failure between patients with a DE < 1.0 cm compared to those with a DE > 1.1 cm, excluding patients where investigators wrongly suspected diaphragm dysfunction.

  Second minute of the SBT

• Subgroup analysis on the difference in the rate of extubation failure between patients with a DE < 1.0 cm compared to those with a DE > 1.1 cm

  Second minute of the SBT

• Difference in the rate of weaning failure between patients with a DE < 1.1 cm compared to those with a DE >= 1.1 cm on the primary endpoint and secondary endpoints 1-4.

  Second minute of the SBT

Other Outcomes (3)

• Efficacy - number of patients with overall acceptable signal quality from predefined quality criteria and time fraction during SBT with this signal quality

  Through the first SBT, an average of 30 minutes

• Safety - Skin irritation frequency and severity

  Through the first SBT, an average of 30 minutes

• Time spent on achieving good sensor placement

  Up to 30 minutes

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 after extubation

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 - 99 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:

• Adult patients, defined as \>=18 years of age, 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, defined by a Charlson Comorbidity Index \< 5%.
• Pregnant woman or protected adult.

Sponsors & Collaborators

• Respinor AS: lead
• Centaur Clinical CRO: collaborator
• Link Medical Research AS: collaborator

Study Sites (8)

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

CHU Angers

Angers, France

Location

Centre Hospitalier Saint Joseph Saint Luc

Lyon, France

Location

CH Saint Joseph Saint Luc

Lyon, France

Location

Hôpital Universitaire Pitié Salpêtrière

Paris, France

Location

Oslo University Hospital

Oslo, 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

Study Design

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

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 14, 2022
• Study Start: December 8, 2022
• Primary Completion: June 30, 2023
• Study Completion: July 30, 2023
• Last Updated: December 18, 2023

Record last verified: 2023-12

Locations

FR (7); NO (1)