Respiratory FailureT-REXNCT05652699
Effect of HFNO Therapy on Respiratory Effort After Extubation
A study testing High Flow Nasal Oxygen and Conventional Oxygen Therapy in people with Respiratory Failure and Post Extubation Acute Respiratory Failure Requiring Reintubation, run by Henrik Endeman at 2 sites in Netherlands.
Trial summary
Rationale: Despite the lack of clear clinical protocols, High Flow Nasal Oxygen (HFNO) is used as post-extubation respiratory support. Although HFNO seems to reduce the need for re-intubation, scepticism on its use persists as the mechanism of action in post-extubation patients remains undefined. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Post Extubation Acute Respiratory Failure Requiring Reintubation
- What is being tested?
- High Flow Nasal Oxygen and Conventional Oxygen Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Oct 2022to 22 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years
- Receiving IMV > 48 hours for any cause
- Successfully completing spontaneous breathing trial (SBT) as per local clinical guideline
- Provided written informed consent, through legal representatives on indication
Who cannot join
- Any clinical situation preventing appropriate execution of study procedures
- The presence of a tracheostomy
- Any feature that precludes HFNO-initiation
- Indication for NIV such as hypercapnia at end of SBT, or Obstructive/central Sleep Apnoea Syndrome or Obesity Hypoventilation Syndrome with CPAP use in medical history
- Contra-indication for nasogastric tube or inability to perform adequate PES measurements.
- Known diaphragm paralysis defined as elevated hemi-diaphragm on X-ray and evidence of paralysis during ultrasound (i.e. paradoxal diaphragm movement during sniffing)
- Known pregnancy or current breast-feeding
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Erasmus MC
Rotterdam, 3015GD
Maasstad Ziekenhuis
Rotterdam, 3079 DZ
About this study
Official title: High Flow Nasal Oxygen Therapy Re-evaluated from a Conceptual Point of View: Effect on Respiratory Effort and Lung Aeration After Extubation
Rationale: Despite the lack of clear clinical protocols, High Flow Nasal Oxygen (HFNO) is used as post-extubation respiratory support. Although HFNO seems to reduce the need for re-intubation, scepticism on its use persists as the mechanism of action in post-extubation patients remains undefined. Monitoring weaning from invasive mechanical ventilation while monitoring respiratory effort might help to determine the added value of HFNO surrounding extubation. We hypothesize that HFNO, compared to conventional oxygen therapy (COT), prevents de-recruitment of the lung and reduces respiratory effort, and so provides a physiologic clarification for the reduction in the need for reintubation.
Objective: Determine the physiological effect of HFNO compared to COT in the extubation phase regarding respiratory effort and lung aeration.
Read more
Study design: A physiologic, randomized clinical study comparing two standard of clinical care therapies.
Study population: Adult patients on invasive mechanical ventilation (IMV) for >72 hours, who are scheduled for extubation.
Intervention (if applicable): Before extubation, patients are randomized to receive COT (reference group) or HFNO as oxygenation regimen after extubation.
Main study parameters/endpoints: The main outcome is the difference in change in lung respiratory muscle effort (mean ΔPES) at 24 hours post-extubation between the study groups. Secondary parameters are differences in changes in respiratory effort at 2 and 4 hours post-extubation, difference in change in lung aeration (mean ΔEELI), differences in tidal volume, dyspnea score, and respiratory and sputum parameters between patients undergoing different post-extubation oxygenation regimens.
- Being tested
- High Flow Nasal Oxygen, Conventional Oxygen Therapy
- Keywords
- High-flow oxygen, Intensive Care Unit, Extubation, Reintubation, Respiratory Effort, Aeration
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow Nasal OxygenOther
Also called High Flow Nasal Cannula, Nasal High Flow Therapy
Flow 60L/minute. FiO2 according to clinical protocol. Temperature highest tolerated by patient, starting with 37 degrees Celsius.
Conventional Oxygen TherapyOther
Nasal Cannula, Venturi Mask or Non-rebreathing mask, according to local clinical protocols
| Study group | Role | What they receive |
|---|---|---|
| High Flow Nasal Oxygen | Active comparator | 60L/minute. FiO2 according to clinical protocol. Temperature highest tolerated by patient, starting with 37 degrees Celcius. Receives: Other: High Flow Nasal Oxygen |
| Conventional Oxygen therapy | Active comparator | Not described Receives: Other: Conventional Oxygen Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
delta Esophageal Pressure (ΔPES)
The difference between groups in change in ΔPES in patients 24 hours post-extubation.
Measured: At 24 hours after extubation
Secondary outcomes (5)
ΔPES
The difference between groups in change in ΔPES after extubation
Measured: At 2 and 4 hours post-extubation
delta global End-expiratory lung impedance (∆EELIglobal)
Difference between the groups in change in mean ∆EELIglobal
Measured: At 2, 4 and 24 hours after extubation
Pressure-time product of Esophageal Pressure (PTPES)
The difference between the groups in mean pressure-time product (PTPES) compared to baseline.
Measured: At 2,4 and 24 hours after extubation
EIT parameters
∆VARt, ∆EELIdependent, ∆EELInon-dependent compared to baseline (impedance on IMV).
Measured: At 2, 4 and 24 hours after extubation
Global Inhomogeneity index
Measured: At 2, 4 and 24 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start1 Oct 2022
- Primary completion22 Oct 2024
- Study completion22 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henrik Endeman
- Sponsor type
- University, hospital or other
- Collaborators
- Franciscus Gasthuis, Maasstad Hospital
- Responsible party
- Sponsor-investigator, Henrik Endeman, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652699
- Sponsor's protocol ID
- NL80844.078.22
- Acronym
- T-REX
- Status last verified
- Jan 2025
- First submitted
- 23 Nov 2022
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Janssen ML, Weller D, Wils EJ, Lupgens N, den Uil CA, Boer DP, Gommers DAMPJ, Heunks LMA, Jonkman AH, Endeman H. Physiological Effects of High-Flow Nasal Oxygen Compared With Conventional Oxygen Therapy: A Randomized Trial in Postextubation Patients. Crit Care Med. 2026 Apr 1;54(4):836-847. doi: 10.1097/CCM.0000000000006993. Epub 2025 Dec 15.
PubMed 41395998
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Oxygen Therapy Re-evaluated from a Conceptual Point of View: Effect on Respiratory Effort and Lung Aeration After Extubation
- ClinicalTrials.gov ID
- NCT05652699
- Acronym / sponsor ID
- T-REX / NL80844.078.22
- Keywords
- High-flow oxygen, Intensive Care Unit, Extubation, Reintubation, Respiratory Effort, Aeration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Henrik EndemanUniversity, hospital or other
- Collaborators
- Franciscus Gasthuis, Maasstad Hospital
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 22 Oct 2024 (actual)
- Study completion
- 22 Oct 2024 (actual)
- First posted
- 15 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: Despite the lack of clear clinical protocols, High Flow Nasal Oxygen (HFNO) is used as post-extubation respiratory support. Although HFNO seems to reduce the need for re-intubation, scepticism on its use persists as the mechanism of action in post-extubation patients remains undefined. Monitoring weaning from invasive mechanical ventilation while monitoring respiratory effort might help to determine the added value of HFNO surrounding extubation. We hypothesize that HFNO, compared to conventional oxygen therapy (COT), prevents de-recruitment of the lung and reduces respiratory effort, and so provides a physiologic clarification for the reduction in the need for reintubation.
Objective: Determine the physiological effect of HFNO compared to COT in the extubation phase regarding respiratory effort and lung aeration.
Study design: A physiologic, randomized clinical study comparing two standard of clinical care therapies.
Study population: Adult patients on invasive mechanical ventilation (IMV) for >72 hours, who are scheduled for extubation.
Intervention (if applicable): Before extubation, patients are randomized to receive COT (reference group) or HFNO as oxygenation regimen after extubation.
Main study parameters/endpoints: The main outcome is the difference in change in lung respiratory muscle effort (mean ΔPES) at 24 hours post-extubation between the study groups. Secondary parameters are differences in changes in respiratory effort at 2 and 4 hours post-extubation, difference in change in lung aeration (mean ΔEELI), differences in tidal volume, dyspnea score, and respiratory and sputum parameters between patients undergoing different post-extubation oxygenation regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Flow Nasal Oxygen | Active comparator | Other: High Flow Nasal Oxygen60L/minute. FiO2 according to clinical protocol. Temperature highest tolerated by patient, starting with 37 degrees Celcius. |
| Conventional Oxygen therapy | Active comparator | Other: Conventional Oxygen Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged ≥ 18 years
- Receiving IMV > 48 hours for any cause
- Successfully completing spontaneous breathing trial (SBT) as per local clinical guideline
- Provided written informed consent, through legal representatives on indication
Key exclusion criteria (7 listed)
- Any clinical situation preventing appropriate execution of study procedures
- The presence of a tracheostomy
- Any feature that precludes HFNO-initiation
- Indication for NIV such as hypercapnia at end of SBT, or Obstructive/central Sleep Apnoea Syndrome or Obesity Hypoventilation Syndrome with CPAP use in medical history
- Contra-indication for nasogastric tube or inability to perform adequate PES measurements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Flow Nasal OxygenAlso: High Flow Nasal Cannula, Nasal High Flow TherapyFlow 60L/minute. FiO2 according to clinical protocol. Temperature highest tolerated by patient, starting with 37 degrees Celsius. | Other | High Flow Nasal Oxygen |
| Conventional Oxygen TherapyNasal Cannula, Venturi Mask or Non-rebreathing mask, according to local clinical protocols | Other | Conventional Oxygen therapy |
Primary outcome
delta Esophageal Pressure (ΔPES)
Time frame: At 24 hours after extubation
The difference between groups in change in ΔPES in patients 24 hours post-extubation.
5 secondary outcomes
ΔPES
Time frame: At 2 and 4 hours post-extubation
delta global End-expiratory lung impedance (∆EELIglobal)
Time frame: At 2, 4 and 24 hours after extubation
Pressure-time product of Esophageal Pressure (PTPES)
Time frame: At 2,4 and 24 hours after extubation
EIT parameters
Time frame: At 2, 4 and 24 hours after extubation
Global Inhomogeneity index
Time frame: At 2, 4 and 24 hours after extubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Derived from this study: PubMed 41395998Janssen ML, Weller D, Wils EJ, Lupgens N, den Uil CA, Boer DP, Gommers DAMPJ, Heunks LMA, Jonkman AH, Endeman H. Physiological Effects of High-Flow Nasal Oxygen Compared With Conventional Oxygen Therapy: A Randomized Trial in Postextubation Patients. Crit Care Med. 2026 Apr 1;54(4):836-847. doi: 10.1097/CCM.0000000000006993. Epub 2025 Dec 15.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Flow Nasal Oxygen and Conventional Oxygen Therapy in people with Respiratory Failure and Post Extubation Acute Respiratory Failure Requiring Reintubation, run by Henrik Endeman at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
delta Esophageal Pressure (ΔPES) (time frame: At 24 hours after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05652699, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.