NCT07714564

Brief Summary

Multicentre randomized trial to determine whether tracheal high-flow nasal oxygen can improve weaning outcome vs. conventional oxygen therapy in critically ill tracheostomized patients who are hypoxemic.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started Oct 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 20, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2029

Last Updated

July 20, 2026

Status Verified

July 1, 2026

Enrollment Period

2.3 years

First QC Date

July 15, 2026

Last Update Submit

July 15, 2026

Conditions

TracheostomyMechanical VentilationHypoxemic Respiratory Failure

Outcome Measures

Primary Outcomes (1)

  • Succesful weaning

    proportion of patients weaned from mechanical ventilation at day 7 after randomization. Weaning is defined as being disconnected from the mechanical ventilator on day 7 and remaining off the ventilator for at least the subsequent 48 consecutive hours without reconnection.

    Day 7 after randomization

Secondary Outcomes (11)

  • Succesful weaning - Day 28

    Day 28 after randomization

  • Time to successful weaning from mechanical ventilation

    90 days

  • Number of reconnections required to the ventilator

    90 days

  • Mechanical ventilation-free days

    Day 28, 60 and 90

  • Intensive care unit-free days

    Day 28, 60 and 90

  • +6 more secondary outcomes

Study Arms (2)

High-flow oxygen

EXPERIMENTAL

Maximum tolerated flow (up to 50-60 L/min), humidification chamber temperature set at 37 °C and FiO2 titrated to obtain SpO2 ≥92% and ≤98%, or 88%-92% for hypercapnic patients. Flow reduction will be allowed in case of intolerance and/or according to patients' requirements: flow ≥30 L/min will be mandatory in all enrolled patients. Weaning from high-flow will not be considered before 24 hours from study enrolment and will be discouraged until the patient is considered for intensive care unit discharge. After weaning, patients will receive conventional oxygen.

Other: Oxygen therapy

Conventional oxygen

ACTIVE COMPARATOR

Patients will receive standard oxygen therapy via a heat and moisture exchanger (Tracheolife) or a Venturi tracheal mask device connected to a humidified source of oxygen. Oxygen flow or VenturiMask FiO2 will be titrated to obtain SpO2 ≥92% and ≤98%, or 88%-92% for hypercapnic patients. The use of tracheal high-flow will not be allowed under any circumstances in patients in this group.

Other: Oxygen therapy

Interventions

Oxygen therapyOTHER

Oxygen supplementation delivered to the patient after disconnection from mechanical ventilation.

Conventional oxygenHigh-flow oxygen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Tracheostomy
  • Plan to receive weaning from mechanical ventilation after more than 48 hours of mechanical ventilation
  • Hypoxemia (PaO2/FiO2\<300) while on mechanical ventilation

You may not qualify if:

  • anticipated need for long-term mechanical ventilation
  • scheduled reconnections to mechanical ventilation
  • neuromuscular disease
  • chronic ventilator dependence
  • planned nocturnal home ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICU, Fondazione Policlinico A. Gemelli IRCCS

Rome, 00198, Italy

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Officials

  • Domenico Luca Grieco

    Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Domenico Luca Grieco, MD

CONTACT

+393397681623domenicoluca.grieco@unicatt.it

Tommaso Rosà, MD

CONTACT

+393401427210tommasoros22@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2026

First Posted

July 20, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

April 30, 2029

Last Updated

July 20, 2026

Record last verified: 2026-07

Locations

IT(1)