Acute Hypoxemic Respiratory FailureHFOTNCT03133520
Effectiveness of High Flow Oxygen Therapy in Patients With Hematologic Malignancy Acute Hypoxemic Respiratory Failure
A study testing High flow oxygen therapy in people with Acute Hypoxemic Respiratory Failure and Hematologic Malignancy, run by Kursat Gundogan at 1 site in Turkey (Türkiye).
Trial summary
Effectiveness of high flow oxygen therapy in patients with hematologic malignancy acute hypoxemic respiratory failure Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Hypoxemic Respiratory Failure, Hematologic Malignancy
- What is being tested?
- High flow oxygen therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2016to 14 Sep 2018
- 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
- Known immunosuppression defined as haematological malignancy.
- Need for oxygen therapy defined as with oxygen free arterial blood gas examination one or more of the following: (a) PaO2/FiO2<300 mmHg (b) PaCO2≤45 mmHg (c) SaO2<92%
- Respiratory distress with a respiratory rate >22/min
Who cannot join
- Refusal of study participation
- Pregnancy or breastfeeding
- Hypercapnia with a formal indication for non-invasive mechanical ventilation (NIMV) (PaCO2 ≥ 45 mmHg)
- Patients whose clinicians have decided on NIMV (Non-Invasive Mechanical Ventilation) and IMV (Invasive Mechanical Ventilation)
- Haemodynamic instability (mean arterial pressure <65 mmHg)
- Vasopressor needs
- Awareness confusion and disorientation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes University Medical School
Kayseri, 38039
About this study
Effectiveness of high flow oxygen therapy in patients with hematologic malignancy acute hypoxemic respiratory failure
Read the detailed description
Acute respiratory failure (ARF) is the leading reason for ICU admission in immunocompromised patients. Usual oxygen therapy involves administering low-to-medium oxygen flows through a nasal cannula or mask to achieve SpO2≥95%.
High-flow nasal oxygen [HFNO] therapy is a focus of growing attention as an alternative to standard oxygen therapy. By providing warmed and humidified gas, HFNO allows the delivery of higher flow rates [of up to 60 L/min] via nasal cannula devices, with fraction of inspired oxygen (FiO2) values of nearly 100%. Physiological benefits of HFNO consist of higher and constant FiO2 values, decreased work of breathing, nasopharyngeal washout leading to improved breathing-effort efficiency, and higher positive airway pressures associated with better lung recruitment.
Clinical consequences of these physiological benefits include alleviation of dyspnea and discomfort, decreases in tachypnea and signs of respiratory distress, a diminished need for intubation in patients with severe hypoxemia, and decreased mortality in unselected patients with acute hypoxemic respiratory failure However, although preliminary data establish the feasibility and safety of this technique, HFNO has never been properly evaluated in immunocompromised patients.
Thus, this project aims at demonstrating that HFNO is superior to low/medium-flow (standard) oxygen, minimizing the need for endotracheal intubation
- Being tested
- High flow oxygen therapy
- Keywords
- Respiratory failure, immuncompromise patients, high flow oxygen
- Medical subject headings
- Respiratory Insufficiency, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow oxygen therapyDevice
High-flow nasal oxygen [HFNO] therapy is a focus of growing attention as an alternative to standard oxygen therapy. By providing warmed and humidified gas, HFNO allows the delivery of higher flow rates [of up to 60 L/min] via nasal cannula devices, with fraction of inspired oxygen(FiO2) values of nearly 100%.
| Study group | Role | What they receive |
|---|---|---|
| Standard oxygen group | No intervention | This patient groups will receive only routine oxygen therapy. Routine oxygen therapy involves administering low-to-medium oxygen flows through a nasal cannula or mask to achieve SpO2≥95%. |
| High flow oxygen therapy group | Experimental | This patients group will receive high flow oxygen therapy. High flow nasal oxygen therapy is a focus of growing attention as an alternative to standard oxygen therapy. By providing warmed and humidified gas, it allows the delivery of higher flow rates [of up to 60 L/min] via nasal cannula devices, with fraction of inspired oxygen(FiO2) values of nearly 100%. Receives: Device: High flow oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation rate
Intubation rate for each group
Measured: First seven days
Secondary outcomes (2)
Mortality
All-cause day-28 mortality
Measured: First 28 days
patients comforts
Patient comfort with Visual Analogue Scale (VAS) score
Measured: First 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start1 Nov 2016
- Primary completion14 Sep 2018
- Study completion14 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Hypoxemic 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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kursat Gundogan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kursat Gundogan, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133520
- Sponsor's protocol ID
- November, 2016
- Acronym
- HFOT
- Status last verified
- Jun 2020
- First submitted
- 13 Apr 2017
- Last updated
- 12 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Turkoglu M, Erdem GU, Suyani E, Sancar ME, Yalcin MM, Aygencel G, Aki Z, Sucak G. Acute respiratory distress syndrome in patients with hematological malignancies. Hematology. 2013 May;18(3):123-30. doi: 10.1179/1607845412Y.0000000038. Epub 2012 Nov 15.
PubMed 23321772Lemiale V, Mokart D, Mayaux J, Lambert J, Rabbat A, Demoule A, Azoulay E. The effects of a 2-h trial of high-flow oxygen by nasal cannula versus Venturi mask in immunocompromised patients with hypoxemic acute respiratory failure: a multicenter randomized trial. Crit Care. 2015 Nov 2;19:380. doi: 10.1186/s13054-015-1097-0.
PubMed 26521922Maggiore SM, Idone FA, Vaschetto R, Festa R, Cataldo A, Antonicelli F, Montini L, De Gaetano A, Navalesi P, Antonelli M. Nasal high-flow versus Venturi mask oxygen therapy after extubation. Effects on oxygenation, comfort, and clinical outcome. Am J Respir Crit Care Med. 2014 Aug 1;190(3):282-8. doi: 10.1164/rccm.201402-0364OC.
PubMed 25003980Hernandez G, Vaquero C, Gonzalez P, Subira C, Frutos-Vivar F, Rialp G, Laborda C, Colinas L, Cuena R, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Conventional Oxygen Therapy on Reintubation in Low-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Apr 5;315(13):1354-61. doi: 10.1001/jama.2016.2711.
PubMed 26975498
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of High Flow Oxygen Therapy in Patients With Hematologic Malignancy Acute Hypoxemic Respiratory Failure
- ClinicalTrials.gov ID
- NCT03133520
- Acronym / sponsor ID
- HFOT / November, 2016
- Keywords
- Respiratory failure, immuncompromise patients, high flow oxygen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Kursat GundoganUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 14 Sep 2018 (actual)
- Study completion
- 14 Sep 2018 (actual)
- First posted
- 28 Apr 2017 (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.
Effectiveness of high flow oxygen therapy in patients with hematologic malignancy acute hypoxemic respiratory failure
Detailed description
Acute respiratory failure (ARF) is the leading reason for ICU admission in immunocompromised patients. Usual oxygen therapy involves administering low-to-medium oxygen flows through a nasal cannula or mask to achieve SpO2≥95%.
High-flow nasal oxygen [HFNO] therapy is a focus of growing attention as an alternative to standard oxygen therapy. By providing warmed and humidified gas, HFNO allows the delivery of higher flow rates [of up to 60 L/min] via nasal cannula devices, with fraction of inspired oxygen (FiO2) values of nearly 100%. Physiological benefits of HFNO consist of higher and constant FiO2 values, decreased work of breathing, nasopharyngeal washout leading to improved breathing-effort efficiency, and higher positive airway pressures associated with better lung recruitment.
Clinical consequences of these physiological benefits include alleviation of dyspnea and discomfort, decreases in tachypnea and signs of respiratory distress, a diminished need for intubation in patients with severe hypoxemia, and decreased mortality in unselected patients with acute hypoxemic respiratory failure However, although preliminary data establish the feasibility and safety of this technique, HFNO has never been properly evaluated in immunocompromised patients.
Thus, this project aims at demonstrating that HFNO is superior to low/medium-flow (standard) oxygen, minimizing the need for endotracheal intubation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard oxygen group | No intervention | –This patient groups will receive only routine oxygen therapy. Routine oxygen therapy involves administering low-to-medium oxygen flows through a nasal cannula or mask to achieve SpO2≥95%. |
| High flow oxygen therapy group | Experimental | Device: High flow oxygen therapyThis patients group will receive high flow oxygen therapy. High flow nasal oxygen therapy is a focus of growing attention as an alternative to standard oxygen therapy. By providing warmed and humidified gas, it allows the delivery of higher flow rates [of up to 60 L/min] via nasal cannula devices, with fraction of inspired oxygen(FiO2) values of nearly 100%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Known immunosuppression defined as haematological malignancy.
- Need for oxygen therapy defined as with oxygen free arterial blood gas examination one or more of the following: (a) PaO2/FiO2<300 mmHg (b) PaCO2≤45 mmHg (c) SaO2<92%
- Respiratory distress with a respiratory rate >22/min
Key exclusion criteria (7 listed)
- Refusal of study participation
- Pregnancy or breastfeeding
- Hypercapnia with a formal indication for non-invasive mechanical ventilation (NIMV) (PaCO2 ≥ 45 mmHg)
- Patients whose clinicians have decided on NIMV (Non-Invasive Mechanical Ventilation) and IMV (Invasive Mechanical Ventilation)
- Haemodynamic instability (mean arterial pressure <65 mmHg)
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 oxygen therapyHigh-flow nasal oxygen [HFNO] therapy is a focus of growing attention as an alternative to standard oxygen therapy. By providing warmed and humidified gas, HFNO allows the delivery of higher flow rates [of up to 60 L/min] via nasal cannula devices, with fraction of inspired oxygen(FiO2) values of nearly 100%. | Device | High flow oxygen therapy group |
Primary outcome
Intubation rate
Time frame: First seven days
Intubation rate for each group
2 secondary outcomes
Mortality
Time frame: First 28 days
patients comforts
Time frame: First 24 hours
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 12 Jun 2020.
- Background: PubMed 23321772Turkoglu M, Erdem GU, Suyani E, Sancar ME, Yalcin MM, Aygencel G, Aki Z, Sucak G. Acute respiratory distress syndrome in patients with hematological malignancies. Hematology. 2013 May;18(3):123-30. doi: 10.1179/1607845412Y.0000000038. Epub 2012 Nov 15.
- Background: PubMed 26521922Lemiale V, Mokart D, Mayaux J, Lambert J, Rabbat A, Demoule A, Azoulay E. The effects of a 2-h trial of high-flow oxygen by nasal cannula versus Venturi mask in immunocompromised patients with hypoxemic acute respiratory failure: a multicenter randomized trial. Crit Care. 2015 Nov 2;19:380. doi: 10.1186/s13054-015-1097-0.
- Background: PubMed 25003980Maggiore SM, Idone FA, Vaschetto R, Festa R, Cataldo A, Antonicelli F, Montini L, De Gaetano A, Navalesi P, Antonelli M. Nasal high-flow versus Venturi mask oxygen therapy after extubation. Effects on oxygenation, comfort, and clinical outcome. Am J Respir Crit Care Med. 2014 Aug 1;190(3):282-8. doi: 10.1164/rccm.201402-0364OC.
- Background: PubMed 26975498Hernandez G, Vaquero C, Gonzalez P, Subira C, Frutos-Vivar F, Rialp G, Laborda C, Colinas L, Cuena R, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Conventional Oxygen Therapy on Reintubation in Low-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Apr 5;315(13):1354-61. doi: 10.1001/jama.2016.2711.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High flow oxygen therapy in people with Acute Hypoxemic Respiratory Failure and Hematologic Malignancy, run by Kursat Gundogan at 1 site in Turkey (Türkiye).
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 3 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 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Intubation rate (time frame: First seven days). 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 NCT03133520, which also lists 4 linked publications.
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 12 Jun 2020.