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

NCT ID: NCT04696406

Last Updated: 2023-12-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 193 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-11
• Study Completion Date: 2022-04-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Weaning failure

Defined as the failure to pass a spontaneous breathing trial or the need for reintubation or death within 48 hours

RESPINOR DXT

Intervention Type: 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 success

Defined as a successful spontaneous breathing trial and is not reintubated or dies in the first 48 hours after extubation.

RESPINOR DXT

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients willing and able to give informed consent (either themselves or next of kin)

2. Have undergone invasive mechanical ventilation > 24 hours

3. Ready to wean according to criteria (from the sixth international consensus conference on intensive care medicine):

1. Adequate cough

2. Absence of excessive tracheobronchial secretion

3. Resolution of disease acute phase for which the patient was intubated

4. 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

5. Adequate oxygenation, defined as SaO2 > 90% on < FIO2 0.4 (or PaO2/FIO2 > 150 mmHg) and PEEP < 8 cmH2O

6. Adequate pulmonary function, i.e. fR < 35 breaths·min-1

7. 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

1. Not registered with a social security system nor entitled to be

2. Central or spinal neurological injury involving central ventilatory control

3. Presence of a neuromuscular disease involving respiratory muscles

4. Use of muscle-paralyzing agents within 24h before the study, except if given for intubation

5. 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

6. Tracheostomy

7. Body mass index >35 kg/m2

8. Patient with therapeutic limitation, i.e. reduced expectancy to survive

9. Pregnant woman or protected adult

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Research Council of Norway

OTHER

Sponsor Role: collaborator

Respinor AS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandre Demoule, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Universitaire Pitié Salpêtrière

Michele Umbrello, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale San Carlo Borromeo

Øyvind Skraastad, MD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Hopital Saint-Antoine

Paris, Cedex 12, France

Hôpitaux Universitaires de Marseille - AP-HM

Marseille, Chem. Des Bourrely, France

Centre Hospitalier Universitaire de Montpellier

Montpellier, Select One..., 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

Countries

France; Italy; Norway

Other Identifiers

DXT-CS-005

Identifier Type: -

Identifier Source: org_study_id