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

NCT05580185 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 145

Last updated 2023-12-18

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Centaur Clinical CRO

    collaborator UNKNOWN

  • Link Medical Research AS

    collaborator UNKNOWN

  • Respinor AS

    lead INDUSTRY

Principal Investigators

  • Alexandre Demoule, MD · Hôpital Universitaire Pitié Salpêtrière

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-08
Primary Completion
2023-06-30
Completion
2023-07-30

Countries

  • France
  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05580185 on ClinicalTrials.gov