NCT05580185 (DE-RISK WF II) is a clinical trial of RESPINOR DXT in Respiratory Failure, sponsored by Respinor AS.

Who is sponsoring NCT05580185?

NCT05580185 is sponsored by Respinor AS.

What drugs are being tested in NCT05580185?

Interventions in NCT05580185: RESPINOR DXT.

What condition does NCT05580185 study?

NCT05580185 studies Respiratory Failure.

Is NCT05580185 still recruiting?

NCT05580185 is currently completed. Last updated 18 December 2023.

Last reviewed 2023-12-18 · How we verify

NCT05580185: DE-RISK WF II

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Last updated 18 December 2023

What this trial tests

trial testing RESPINOR DXT in Respiratory Failure in 145 participants. Completed in 30 July 2023.

Timeline

8 December 2022

Primary endpoint
30 June 2023

30 July 2023

Quick facts

Lead sponsor	Respinor AS
Status	Completed
Study type	OBSERVATIONAL
Enrollment	145
Start date	8 December 2022
Primary completion	30 June 2023
Estimated completion	30 July 2023
Sites	8 locations across France, Norway

Drugs / interventions tested

RESPINOR DXT

Conditions studied

Respiratory Failure — all drugs for Respiratory Failure →

Sponsor

Respinor AS

Who can join

Adults 18 to 99, any sex, with Respiratory Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of RESPINOR DXT

Trials testing the same drug.

NCT04696406 — Multicenter, Multinational, Clinical Trial of the Performance of RESPINOR DXT to Identify Patients at Increased Risk of · completed

Other recruiting trials for Respiratory Failure

Currently open trials in the same condition.

NCT07522450 — Benefit of Sleep Quality Monitoring by EEG in ICU · recruiting
NCT07359261 — Transpulmonary Assessment for Individualized Lung Optimization in Obese Patients · Phase 2 · recruiting
NCT07536750 — Comparison of the Efficacy and Safety of Ciprofol Versus Propofol for Sedation in ICU Patients Undergoing Non-Invasive V · recruiting
NCT07114289 — Spontaneous Breathing Trials Using Pressure Support or T-Piece in Overweight and Obese Patients · NA · recruiting
NCT06591533 — The Effect of Music Therapy on Vital Signs and Heart Rate Variability of Pediatric Patients During the Extubation Proces · NA · recruiting

Other Respinor AS trials

Trials by the same sponsor.

NCT04696406 — Multicenter, Multinational, Clinical Trial of the Performance of RESPINOR DXT to Identify Patients at Increased Risk of · completed
NCT04008875 — Improvement of Weaning From Mechanical Ventilation by Continuous Ultrasound Monitoring of Diaphragm Excursion · completed
NCT03896048 — Continuous Measurement of Diaphragm Excursion as a Predictor of Extubation Failure · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05580185 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Respinor AS
Last refreshed: 18 December 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05580185.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing