RECRUITING

ROX Index for the Timing of Intubation in Nasal High Flow

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Late or delayed intubation in patients with acute hypoxemic respiratory failure (AHRF) treated with nasal high flow (NHF) is associated with increased patient mortality. The ROX index has been designed and validated to predict outcome of NFH therapy by identifying those patients with a high risk of NHF failure and those with a high probability of success. Whether or not the ROX index may improve patient outcome remains to be shown. To do so, a strategy using the ROX index must lead to earlier intubation than commonly-used criteria. The objective of the ROX-1 trial is to assess whether the use of an algorithm incorporating the ROX index to standard of care for the time to intubation in patients with AHRF supported with NHF isassociated with an increase in the proportion of patients who are intubated within the first 12 hours among those patients who fail on NHF.

Official Title

ROX Index Compared to Standard of Care for the Timing of Intubation in Patients Supported by Nasal High Flow: a Randomized Controlled Trial

Quick Facts

Study Start:2020-12-09
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04707729

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 120 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * All consecutive patients older than 18 years with acute hypoxemic respiratory failure who need to be supported with nasal high flow (NHF) will be considered for inclusion.
  2. * Criteria for initiation of NHF if they had a respiratory rate \> 25 breaths/min and/or pulse oximetry (SpO2) \< 92% while receiving standard oxygen administered through a facemask at 10 L/mn or more.
  3. * Patients already treated with NHF for acute respiratory failure prior to ICU admission will be enrolled if duration of NHF prior to randomization does not exceed one hour.
  1. * Patients younger than 18 years old.
  2. * Patients with indication for immediate intubation.
  3. * Patients treated with NHF for more than 1h prior to randomization.
  4. * Patients with do-not-intubate order.
  5. * Patients electively intubated for diagnostic or therapeutic procedures. (fibrobronchoscopy, surgery).
  6. * Patients with no pulmonary infiltrates on chest X-ray
  7. * Patient with post-extubation AHRF.
  8. * Awake ECMO.
  9. * Pregnancy.
  10. * Refusal to participate or participation in another interventional study with the same primary outcome.

Contacts and Locations

Study Contact

Oriol Roca, MD PhD
CONTACT
+34932746209
oroca@tauli.cat

Principal Investigator

Oriol Roca, MD PhD
PRINCIPAL_INVESTIGATOR
Universitat Autònoma de Barcelona (UAB)

Study Locations (Sites)

Rush University Chicago Hospital
Chicago, Illinois, 60612
United States

Collaborators and Investigators

Sponsor: Hospital Universitari Vall d'Hebron Research Institute

  • Oriol Roca, MD PhD, PRINCIPAL_INVESTIGATOR, Universitat Autònoma de Barcelona (UAB)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-09
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2020-12-09
Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

  • High flow nasal cannula
  • Nasal high flow
  • High flow oxygen therapy

Additional Relevant MeSH Terms

  • Acute Hypoxemic Respiratory Failure