Respiratory FailureNCT03788304
High Flow Nasal Cannula Versus Non-invasive Ventilation in Prevention of Escalation to Invasive Mechanical Ventilation in Patients With Acute Hypoxemic Respiratory Failure
A study testing non-invasive ventilation and high flow nasal cannula in people with Respiratory Failure, run by Assiut University at 1 site in Egypt.
Trial summary
Oxygen therapy is first-line treatment in the management of acute respiratory failure (ARF). Different oxygen devices have become available over recent decades, such as low-flow systems (nasal cannula, simple facemask, non-rebreathing reservoir mask) and high-flow systems (Venturi mask) . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- non-invasive ventilation and high flow nasal cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2019to 1 Dec 2020
- 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
- Participants admitted to the RICU with acute hypoxemic respiratory failure requiring NIV support with the following criteria:
- RR> 25 breath/minute
- Use of accessory muscles of respiration, paradoxical breathing, thoracoabdominal asynchrony.
- Hypoxemia evidenced by PaO2 / FiO2 ratio <300
Who cannot join
- Patients who have any of the following:
- Indication for emergency endotracheal intubation. II. HR <50 beat\minute with decreased level of consciousness III. Persistent hemodynamic instability with
- Systolic blood pressure <90 mmHg after infusing a bolus of crystalloid solution at a dose of 30 ml / kg
- life-threatening arrhythmia. IV. Undrained pneumothorax or Pneumothorax with persistent air leak. V. Extensive facial trauma or burn VI. Refusal to participate. VII. Usual long-term treatment with NIV for chronic disease VIII. Altered mental status with decreased consciousness and/or evidence of inability to understand .
- Tracheotomy or other upper airway disorders X. Active upper gastrointestinal bleeding
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University hospital
Asyut, assiut University 71515
Entsar H mohamed, master, 01019968106, dr.entsar_hsanen@yahoo.com
Gamal M Rabie, MD, 01155213224, Gamalagmy135@gmail.com
About this study
Oxygen therapy is first-line treatment in the management of acute respiratory failure (ARF). Different oxygen devices have become available over recent decades, such as low-flow systems (nasal cannula, simple facemask, non-rebreathing reservoir mask) and high-flow systems (Venturi mask) . Since the 90's, non-invasive ventilation (NIV) has been largely used with strong level of evidence in cardiogenic pulmonary edema and chronic obstructive pulmonary disease (COPD) exacerbation. NIV improves gas exchange and reduces inspiratory effort through positive pressure. However, good tolerance to NIV is sometimes difficult to achieve due to frequent leaks around the mask, possibly leading to patient-ventilator asynchrony and even to intubation . High-flow nasal oxygen therapy (HFNO) is an innovative high-flow system that allows for delivering up to 60 liters\ min of heated and fully humidified gas with a FIO2 ranging between 21% and 100% . It is a new method of respiratory support in adults that has been used in neonatal ARF for some years. The reason this study is necessary is because, even though NIV has been demonstrated to prevent endotracheal intubation (and its associated complications) in a broad range of ARF patients, HFNC has been proposed to have the same effect as NIV while being easier tolerated, more physiological , allowing patients to continue to talk, eat and drink through mouth while on HFNC
Read the detailed description
Oxygen therapy is the first-line treatment in management of acute respiratory failure (ARF). Different oxygen delivery devices have become available over recent decades, either low-flow systems (nasal cannula, simple facemask, non-rebreathing reservoir mask) or high-flow systems (Venturi mask) . The choice of a specific device in management of ARF is based on the severity of hypoxemia, the underlying mechanisms, the patient's breathing pattern and tolerance .
Critically ill patients often require high-flow devices to meet their oxygen needs . Tachypneic patients with ARF, have a peak inspiratory flow rate that is usually high and often exceeds the oxygen flow delivered by the traditional oxygen devices . Using conventional devices, oxygen flow is limited to no more than 15 L/min. Meanwhile, the required inspiratory flow for patients with respiratory failure varies widely in a range from 30 to120 L/min. The difference between patient inspiratory flow and delivered flow is large with conventional oxygen devices leading to patient discomfort . Moreover; high respiratory rate can generate significant entrainment of room air in the mask and dilution of the inspired oxygen with an insufficient oxygen concentration. The suboptimal humidification of the inhaled oxygen provided by standard bubble humidifiers and the limited and unknown inspiratory oxygen fraction (FIO2) delivery are additional drawbacks of these devices .
Since the 90's, noninvasive ventilation (NIV) has been largely used with strong level of evidence in cardiogenic pulmonary edema and chronic obstructive pulmonary disease (COPD) exacerbation. NIV improves gas exchange and reduces inspiratory effort through positive pressure. However, good tolerance to NIV is sometimes difficult to achieve due to frequent leaks around the mask, possibly leading to patient-ventilator asynchrony and even to intubation. It may have other deleterious effects such as delayed intubation by masking signs of respiratory distress, or barotrauma by the high tidal volume potentially generated under positive pressure .
To ensure good results, an appropriate interface is more important than the ventilation mode . Oronasal masks, nasal masks, and hoods are most commonly used for NIV. Oronasal masks are usually tried first because they ensure the effects of NIV better than other interfaces. Unfortunately, it is not comfortable, and many patients find it hard to tolerate. It is also associated with a relatively high incidence of air leakage. Also, skin lesions at the nose induced by long-term use of this device may result in frequent treatment interruptions and discontinuation.
High-flow nasal oxygen therapy (HFNO) is an innovative high-flow system that allows for delivering up to 60 liters/ min of heated and fully humidified gas with a FIO2 ranging between 21% and 100% [.
- HFNO delivery systems: main technical characteristics: - The administration of HFNO requires the following: high pressure sources of oxygen and air, an air-oxygen blender or a high-flow 'Venturi' system (which permits delivery of an accurate FIO2 between 21% and 100%), a humidifying and heating system for conditioning the gas to optimal temperature (37 ºC) and humidity (44mg H2O/ liters), a sterile water reservoir, a non-condensing circuitry, and an interface . The two most widely marketed HFNO systems are the Precision Flow by Vapotherm and Optiflow by Fisher \& Pykel Healthcare Ltd.
- Physiological effects of HFNC: - Gas from an air/oxygen blender that can generate a total flow of up to 60 L/min is heated and humidified with an active humidifier and subsequently delivered through a heated circuit. High flow of adequately heated and humidified gas is considered to have a number of physiological effects
- Washout of nasopharyngeal dead space: Washout of upper airway dead space from the delivery of a large amount of oxygen can improve the efficiency of ventilation and enhance oxygen delivery . HFNC is the only noninvasive respiratory support that does not increase dead space. With an oxygen mask, especially at low flow, carbon dioxide is rebreathed .
- Warming and humidification of secretions: Warming of inspired oxygen and heating it to core temperature is more effective at high flow rates (typically >40 L/minute) than low flow rates. Thus, HFNC is better at heating and humidifying inspired oxygen than conventional high-flow systems such as Venturi masks or nonrebreathers (flow rate typically 10 to 15 L/minute) or low-flow systems (flow rates typically <10 L/minute) . Increased humidification results in increased water content in mucous, which can facilitate secretion removal and may also decrease the work of breathing and avoid airway desiccation and epithelial injury
- Continuous positive airway pressure (CPAP) effect: Several studies in adults have shown that, similar to infants and neonates, HFNC increases nasopharyngeal airway pressure that peaks at the end of expiration (ie, "PEEP effect") . This "PEEP effect" can potentially unload auto-PEEP, decrease work of breathing, and enhance oxygenation in patients with alveolar filling diseases such as congestive heart failure or acute respiratory distress syndrome (ARDS). As flow increases, nasopharyngeal pressure increases (ie, a dose effect) . The CPAP effect is greatest with the mouth closed. In general, every increase of 10 L/minute of flow yields approximately 0.7 cm H2O of airway pressure when the mouth is closed and 0.35 cm of H2O when the mouth is open.
- Small pliable nasal prongs: HFNC nasal prongs are generally soft and pliable. Consequently, several studies have reported improved patient comfort with HFNC when compared with conventional low-flow oxygen delivered through nasal cannula or high-flow oxygen delivered through a face mask .
- High flow rates: High flow rates result in minimal entrainment of room air when HFNC is used; this results in more accurate delivery of oxygen. Patients in respiratory distress generate high inspiratory flow rates that exceed flow rates of standard oxygen equipment, resulting in entrainment of room air and a reduction in the delivery of the set FIO2. The rate of flow in HFNC generally exceeds that of the patient, entraining very little room air and resulting in an FIO2 that is more reliably delivered . High flow rates have also been shown to result in an improved breathing pattern by increasing tidal volume and decreasing respiratory rate .
- Reduction of work of breathing: The HFNO system may significantly reduce the energy requirement (metabolic work) associated with gas conditioning. By providing high gas flows, HFNO reduces the resistance of the upper airway and then decreases the resistive breathing effort .
- Conditions
- Respiratory Failure
- Being tested
- non-invasive ventilation, high flow nasal cannula
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive ventilationDevice
conventional NIV
high flow nasal cannulaDevice
HFNC ventilation
| Study group | Role | What they receive |
|---|---|---|
| Non invasive ventilation | Active comparator | Respiratory assistance is provided by a NIV either Puritan Bennet 840 , Engström Carestation or Hamilton-G5 , will be used for conventional non-invasive ventilation via an oronasal mask. Settings will be adjusted based on the clinical assessment of the respiratory therapist . Initial setting includes: -
* Positive End Expiratory Pressure (PEEP): 5 cmH2O.
* Pressure support (PS): 12-20 cmH2O.
* FiO2 will be adjusted to achieve a SpO2 at least 95% Receives: Device: non-invasive ventilation |
| High flow nasal cannula | Experimental | High flow nasal cannula consists of an apparatus that allows adjustable FiO2 from 21 to 100% and delivers a modified gas flow up to 60 l/ min .
will be set with: -
* Temperature at 37°C or 34°C
* Flow rate 30: 50 L/min.
* FiO2 will be adjusted to achieve a SpO2 at least 95% Receives: Device: high flow nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endotracheal intubation rate.
needs escalation to invasive mechanical ventilation
Measured: one week
Secondary outcomes (5)
In hospital mortality.
death
Measured: one week
length of hospital stay
hospital coast
Measured: one week
duration of ICU stay
icu occupancy
Measured: one week
duration of intervention
need ventilatory support
Measured: one week
development of complications
due to devices
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2018
- Study start1 May 2019
- Primary completion30 Apr 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
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.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Model description
- patients with will be randomly enrolled to either non invasive group or HFNC group and improvement and patient satisfaction will be assessed
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Entsar Hsanen Mohamed, Assiut University
- Investigators
- Mohamed F Adam, lecturer, Principal investigator, Assiut UniversityManal A El-Khawaga, lecturer, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03788304
- Sponsor's protocol ID
- High flow nasal cannula
- Status last verified
- Oct 2019
- First submitted
- 20 Dec 2018
- Last updated
- 21 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
1-Renda, T., Corrado, A., Iskandar, G., et al. High-flow nasal oxygen therapy in intensive care and anaesthesia . British journal of anaesthesia 2018 , 120(1), 18-27 2-Kallstrom TJ. AARC clinical practice guideline: oxygen therapy for adults in the acute care facility: 2002 revision and update. Respir Care 2002; 47: 717-20. 3-O'Driscoll BR, Howard LS, Davison AG, on behalf of the British Thoracic Society. BTS guideline for emergency oxygen use in adult patients. Thorax 2008; 63: 1-68. 4-Sim MA, Dean P, Kinsella J, et al. Performance of oxygen delivery devices when the breathing pattern of respiratory failure is simulated. Anaesthesia 2008; 63: 938-40 5-Nishimura, M. High-flow nasal cannula oxygen therapy in adults: physiological benefits, indication, clinical benefits, and adverse effects. Respiratory Care 2016, 61(4), 529-541.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Cannula Versus Non-invasive Ventilation in Prevention of Escalation to Invasive Mechanical Ventilation in Patients With Acute Hypoxemic Respiratory Failure
- ClinicalTrials.gov ID
- NCT03788304
- Acronym / sponsor ID
- High flow nasal cannula
- Conditions
- Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 27 Dec 2018 (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.
Oxygen therapy is first-line treatment in the management of acute respiratory failure (ARF). Different oxygen devices have become available over recent decades, such as low-flow systems (nasal cannula, simple facemask, non-rebreathing reservoir mask) and high-flow systems (Venturi mask) . Since the 90's, non-invasive ventilation (NIV) has been largely used with strong level of evidence in cardiogenic pulmonary edema and chronic obstructive pulmonary disease (COPD) exacerbation. NIV improves gas exchange and reduces inspiratory effort through positive pressure. However, good tolerance to NIV is sometimes difficult to achieve due to frequent leaks around the mask, possibly leading to patient-ventilator asynchrony and even to intubation . High-flow nasal oxygen therapy (HFNO) is an innovative high-flow system that allows for delivering up to 60 liters\ min of heated and fully humidified gas with a FIO2 ranging between 21% and 100% . It is a new method of respiratory support in adults that has been used in neonatal ARF for some years. The reason this study is necessary is because, even though NIV has been demonstrated to prevent endotracheal intubation (and its associated complications) in a broad range of ARF patients, HFNC has been proposed to have the same effect as NIV while being easier tolerated, more physiological , allowing patients to continue to talk, eat and drink through mouth while on HFNC
Detailed description
Oxygen therapy is the first-line treatment in management of acute respiratory failure (ARF). Different oxygen delivery devices have become available over recent decades, either low-flow systems (nasal cannula, simple facemask, non-rebreathing reservoir mask) or high-flow systems (Venturi mask) . The choice of a specific device in management of ARF is based on the severity of hypoxemia, the underlying mechanisms, the patient's breathing pattern and tolerance .
Critically ill patients often require high-flow devices to meet their oxygen needs . Tachypneic patients with ARF, have a peak inspiratory flow rate that is usually high and often exceeds the oxygen flow delivered by the traditional oxygen devices . Using conventional devices, oxygen flow is limited to no more than 15 L/min. Meanwhile, the required inspiratory flow for patients with respiratory failure varies widely in a range from 30 to120 L/min. The difference between patient inspiratory flow and delivered flow is large with conventional oxygen devices leading to patient discomfort . Moreover; high respiratory rate can generate significant entrainment of room air in the mask and dilution of the inspired oxygen with an insufficient oxygen concentration. The suboptimal humidification of the inhaled oxygen provided by standard bubble humidifiers and the limited and unknown inspiratory oxygen fraction (FIO2) delivery are additional drawbacks of these devices .
Since the 90's, noninvasive ventilation (NIV) has been largely used with strong level of evidence in cardiogenic pulmonary edema and chronic obstructive pulmonary disease (COPD) exacerbation. NIV improves gas exchange and reduces inspiratory effort through positive pressure. However, good tolerance to NIV is sometimes difficult to achieve due to frequent leaks around the mask, possibly leading to patient-ventilator asynchrony and even to intubation. It may have other deleterious effects such as delayed intubation by masking signs of respiratory distress, or barotrauma by the high tidal volume potentially generated under positive pressure .
To ensure good results, an appropriate interface is more important than the ventilation mode . Oronasal masks, nasal masks, and hoods are most commonly used for NIV. Oronasal masks are usually tried first because they ensure the effects of NIV better than other interfaces. Unfortunately, it is not comfortable, and many patients find it hard to tolerate. It is also associated with a relatively high incidence of air leakage. Also, skin lesions at the nose induced by long-term use of this device may result in frequent treatment interruptions and discontinuation.
High-flow nasal oxygen therapy (HFNO) is an innovative high-flow system that allows for delivering up to 60 liters/ min of heated and fully humidified gas with a FIO2 ranging between 21% and 100% [.
- HFNO delivery systems: main technical characteristics: - The administration of HFNO requires the following: high pressure sources of oxygen and air, an air-oxygen blender or a high-flow 'Venturi' system (which permits delivery of an accurate FIO2 between 21% and 100%), a humidifying and heating system for conditioning the gas to optimal temperature (37 ºC) and humidity (44mg H2O/ liters), a sterile water reservoir, a non-condensing circuitry, and an interface . The two most widely marketed HFNO systems are the Precision Flow by Vapotherm and Optiflow by Fisher \& Pykel Healthcare Ltd.
- Physiological effects of HFNC: - Gas from an air/oxygen blender that can generate a total flow of up to 60 L/min is heated and humidified with an active humidifier and subsequently delivered through a heated circuit. High flow of adequately heated and humidified gas is considered to have a number of physiological effects
- Washout of nasopharyngeal dead space: Washout of upper airway dead space from the delivery of a large amount of oxygen can improve the efficiency of ventilation and enhance oxygen delivery . HFNC is the only noninvasive respiratory support that does not increase dead space. With an oxygen mask, especially at low flow, carbon dioxide is rebreathed .
- Warming and humidification of secretions: Warming of inspired oxygen and heating it to core temperature is more effective at high flow rates (typically >40 L/minute) than low flow rates. Thus, HFNC is better at heating and humidifying inspired oxygen than conventional high-flow systems such as Venturi masks or nonrebreathers (flow rate typically 10 to 15 L/minute) or low-flow systems (flow rates typically <10 L/minute) . Increased humidification results in increased water content in mucous, which can facilitate secretion removal and may also decrease the work of breathing and avoid airway desiccation and epithelial injury
- Continuous positive airway pressure (CPAP) effect: Several studies in adults have shown that, similar to infants and neonates, HFNC increases nasopharyngeal airway pressure that peaks at the end of expiration (ie, "PEEP effect") . This "PEEP effect" can potentially unload auto-PEEP, decrease work of breathing, and enhance oxygenation in patients with alveolar filling diseases such as congestive heart failure or acute respiratory distress syndrome (ARDS). As flow increases, nasopharyngeal pressure increases (ie, a dose effect) . The CPAP effect is greatest with the mouth closed. In general, every increase of 10 L/minute of flow yields approximately 0.7 cm H2O of airway pressure when the mouth is closed and 0.35 cm of H2O when the mouth is open.
- Small pliable nasal prongs: HFNC nasal prongs are generally soft and pliable. Consequently, several studies have reported improved patient comfort with HFNC when compared with conventional low-flow oxygen delivered through nasal cannula or high-flow oxygen delivered through a face mask .
- High flow rates: High flow rates result in minimal entrainment of room air when HFNC is used; this results in more accurate delivery of oxygen. Patients in respiratory distress generate high inspiratory flow rates that exceed flow rates of standard oxygen equipment, resulting in entrainment of room air and a reduction in the delivery of the set FIO2. The rate of flow in HFNC generally exceeds that of the patient, entraining very little room air and resulting in an FIO2 that is more reliably delivered . High flow rates have also been shown to result in an improved breathing pattern by increasing tidal volume and decreasing respiratory rate .
- Reduction of work of breathing: The HFNO system may significantly reduce the energy requirement (metabolic work) associated with gas conditioning. By providing high gas flows, HFNO reduces the resistance of the upper airway and then decreases the resistive breathing effort .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- patients with will be randomly enrolled to either non invasive group or HFNC group and improvement and patient satisfaction will be assessed
| Arm | Type | Receives |
|---|---|---|
| Non invasive ventilation | Active comparator | Device: non-invasive ventilationRespiratory assistance is provided by a NIV either Puritan Bennet 840 , Engström Carestation or Hamilton-G5 , will be used for conventional non-invasive ventilation via an oronasal mask. Settings will be adjusted based on the clinical assessment of the respiratory therapist . Initial setting includes: - * Positive End Expiratory Pressure (PEEP): 5 cmH2O. * Pressure support (PS): 12-20 cmH2O. * FiO2 will be adjusted to achieve a SpO2 at least 95% |
| High flow nasal cannula | Experimental | Device: high flow nasal cannulaHigh flow nasal cannula consists of an apparatus that allows adjustable FiO2 from 21 to 100% and delivers a modified gas flow up to 60 l/ min . will be set with: - * Temperature at 37°C or 34°C * Flow rate 30: 50 L/min. * FiO2 will be adjusted to achieve a SpO2 at least 95% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants admitted to the RICU with acute hypoxemic respiratory failure requiring NIV support with the following criteria:
Key exclusion criteria (5 listed)
- Indication for emergency endotracheal intubation. II. HR <50 beat\minute with decreased level of consciousness III. Persistent hemodynamic instability with
- Systolic blood pressure <90 mmHg after infusing a bolus of crystalloid solution at a dose of 30 ml / kg
- life-threatening arrhythmia. IV. Undrained pneumothorax or Pneumothorax with persistent air leak. V. Extensive facial trauma or burn VI. Refusal to participate. VII. Usual long-term treatment with NIV for chronic disease VIII. Altered mental status with decreased consciousness and/or evidence of inability to understand .
- Tracheotomy or other upper airway disorders X. Active upper gastrointestinal bleeding
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 |
|---|---|---|
| non-invasive ventilationconventional NIV | Device | Non invasive ventilation |
| high flow nasal cannulaHFNC ventilation | Device | High flow nasal cannula |
Primary outcome
Endotracheal intubation rate.
Time frame: one week
needs escalation to invasive mechanical ventilation
5 secondary outcomes
In hospital mortality.
Time frame: one week
length of hospital stay
Time frame: one week
duration of ICU stay
Time frame: one week
duration of intervention
Time frame: one week
development of complications
Time frame: one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- Background1-Renda, T., Corrado, A., Iskandar, G., et al. High-flow nasal oxygen therapy in intensive care and anaesthesia . British journal of anaesthesia 2018 , 120(1), 18-27 2-Kallstrom TJ. AARC clinical practice guideline: oxygen therapy for adults in the acute care facility: 2002 revision and update. Respir Care 2002; 47: 717-20. 3-O'Driscoll BR, Howard LS, Davison AG, on behalf of the British Thoracic Society. BTS guideline for emergency oxygen use in adult patients. Thorax 2008; 63: 1-68. 4-Sim MA, Dean P, Kinsella J, et al. Performance of oxygen delivery devices when the breathing pattern of respiratory failure is simulated. Anaesthesia 2008; 63: 938-40 5-Nishimura, M. High-flow nasal cannula oxygen therapy in adults: physiological benefits, indication, clinical benefits, and adverse effects. Respiratory Care 2016, 61(4), 529-541.
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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.
Mohamed F Adam, lecturer principal investigator
Assiut University
Manal A El-Khawaga, lecturer principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-invasive ventilation and high flow nasal cannula in people with Respiratory Failure, run by Assiut University at 1 site in Egypt.
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 5 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: status not confirmed, as of the sponsor's last update on 21 Oct 2019. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Entsar H mohamed, MD (+201019968106, dr.entsar_hsanen@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endotracheal intubation rate. (time frame: one week). 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 NCT03788304, 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 21 Oct 2019.