Acute Hypoxemic Respiratory FailureHighflowNCT05499039
High Flow Nasal Cannula Versus Non-Invasive (NIV)in Both Hypoxemic and Hypercapnic Respiratory Failure.
A study testing High flow nasal cannula (HFNC) and Non-Invasive Mechanical Ventilation (NIV) in people with Acute Hypoxemic Respiratory Failure and Acute Hypercapnic Respiratory Failure, run by Assiut University at 1 site in Egypt.
Trial summary
high flow nasal cannula (HFNC) oxygen therapy utilizes an air oxygen blend allowing from 21 % to 1 00% FiO2 delivery and generates up to 60 L/min flow rates The gas is heated and humidified through an active heated humidifier and delivered via a single limb heated inspiratory circuit (to avoid heat loss and… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Acute Hypoxemic Respiratory Failure, Acute Hypercapnic Respiratory Failure
- What is being tested?
- High flow nasal cannula (HFNC) and Non-Invasive Mechanical Ventilation (NIV)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2022to 20 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 18
- Acute hypoxemic respiratory failure. (Participants admitted with acute hypoxemic respiratory 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)
- Acute hypercapnic respiratory failure ((Participants admitted with acute hypercapneic respiratory with the following criteria:
- pO2 less than 60 mm Hg (hypoxemia). pCO2 greater than 50 mm Hg (hypercapnia) with pH less than 7.35. Signs and symptoms of acute respiratory distress)
Who cannot join
- Patients with preprocedural or post-procedural settings (ex: surgery, bronchoscope) post- extubation,
- Patients with cancer or transplant patients,
- Patients less than 18 years old
- Patients with Heart failure patients
- Patients with renal failure patients
- Patients with hemodynamic instability
Show all 12Show fewer
- Patients with central causes of hypercapnic respiratory failure
- Patients with disturbed conscious level
- Patients who refuse to participate in the study
- Indication for emergency endotracheal intubation
- Tracheotomy or other upper airway disorders
- Active upper gastrointestinal bleeding
Trial locations and contacts
1 site in 1 country.
Peter At Rizk contact
About this study
high flow nasal cannula (HFNC) oxygen therapy utilizes an air oxygen blend allowing from 21 % to 1 00% FiO2 delivery and generates up to 60 L/min flow rates The gas is heated and humidified through an active heated humidifier and delivered via a single limb heated inspiratory circuit (to avoid heat loss and condensation) to the patient through a large diameter nasal cannula Theoretically, HFNC offers significant advantages in oxygenation and ventilation over COT. Constant high flow oxygen delivery provides steady FiO2 and decreases oxygen dilution. It also washes out physiologic dead space and generates positive end expiration pressure (PEEP) that augments ventilation The heated humidification facilitates secretion clearance, decreases bronchospasm, and maintains mucosal integrity.
This study aims to evaluate the effectiveness of HFNC compared to NIMV in management of Acute hypoxemic and acute hypercapneic respiratory failure
Read the detailed description
- Acute respiratory failure (ARF) is a common and serious complication among hospitalized patients. It is the most frequent reason for admission to the intensive care unit (ICU) . It carries an in-hospital mortality rate of 20.6% and cost 54.3 billion dollars nationwide in United States in 2009. Among those patients with ARF, 42.1 % of patients require mechanical ventilation (MV), which is associated with a significant increase in both length of stay and medical expense
- ARF can be categorized into acute hypoxemic respiratory failure(AHRF) and acute hypercapneic respiratory failure.
- Supplemental oxygen and treatment of the underlying cause is the mainstay of therapy for AHRF. Options for oxygen therapy include conventional oxygen therapy delivered via nasal cannulae (NC) or face masks (FM) initially, followed by non-invasive ventilation (NIV), and finally intubation or mechanical ventilation (MV) .
- Traditional NC and FM (collectively referred to as conventional oxygen therapy or COT) can achieve flow rates of up to 1 5 L/min. However, these flow rates may be significantly lower than patients' spontaneous inspiratory flow rates and the oxygen is diluted as it is mixed with room air Consequently, the fraction of inspired oxygen (FiO2) delivered Is variable and this is thought to explain why many patients require an escalation of oxygen therapy to NIV or MV.
- By contrast, humidified high flow nasal cannula (HFNC) oxygen therapy utilizes an air oxygen blend allowing from 21 % to 1 00% FiO2 delivery and generates up to 60 L/min flow rates The gas is heated and humidified through an active heated humidifier and delivered via a single limb heated inspiratory circuit (to avoid heat loss and condensation) to the patient through a large diameter nasal cannula Theoretically, HFNC offers significant advantages in oxygenation and ventilation over COT. Constant high flow oxygen delivery provides steady FiO2 and decreases oxygen dilution. It also washes out physiologic dead space and generates positive end expiration pressure (PEEP) that augments ventilation The heated humidification facilitates secretion clearance, decreases bronchospasm, and maintains mucosal integrity
- HFNC has been well studied in the neonatal and pediatric settings However, in adults, the use of HFNC has Primarily been studied in post-cardiac surgery post-extubation and bronchoscopy patients. However, the utility of HFNC use in adults with AHRF in emergency and general inpatient practice is less clear .Heated and humidified high-flow oxygen through nasal cannula (HFNC) has been developed over the past 2 decades, as an alternative to standard oxygen delivery systems
- . In adults, it has been used to treat hypoxemic respiratory failure, cardiogenic pulmonary edema, postoperatively and postextubation in do-not-intubate patients or during bronchoscopy
- To date, the literature supports the possibility to use HFNC as alternative to non-invasive ventilation (NIV) in some settings, while in others might be even superior . It is also an alternative to standard oxygen as first line therapy in management of patients with acute respiratory failure . NIV is strongly recommended in patients with acute-on-chronic respiratory failure associated with acute respiratory acidosis, the vast majority of whom meet the criteria for Chronic Obstructive Pulmonary Disease (COPD) exacerbation
- Recently, Studies revealed no difference of the 30-day mortality and intubation rate between NIV and HFNC, in severe acute exacerbation of COPD with moderate, hypercapnic, acute respiratory failure. In a retrospective study, that suggeste that HFNC oxygen therapy was beneficial, even in respiratory failure Type 2, resulting in significant improvement of both oxygenation and hypercapnia. another study also indicated that HFNO leads to a flow-dependent reduction in PaCO2 in patients with stable hypercapnic COPD, due to a washout of the respiratory tract and a functional reduction in dead space
- Although cumulative evidence supports that HFNC is effective in patients with hypercapnia, randomized studies to compare HFNC vs. NIV in patients with acute, hypercapnic respiratory failure are missing. so the investigator conducting this prospective, randomized, controlled trial, involving patients admitted to the Emergency Department (ED), to compare the efficacy of HFNC versus NIV in the management of acute hypercapnic respiratory failure.
- Being tested
- High flow nasal cannula (HFNC), Non-Invasive Mechanical Ventilation (NIV)
- 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 cannula (HFNC)Device
Also called High velocity nasal insufflation (vapotherm)
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%
Non-Invasive Mechanical Ventilation (NIV)Device
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% Intervention: Device: non-invasive ventilation
| Study group | Role | What they receive |
|---|---|---|
| Group A1 (NIVMV on hypoxemic) | Active comparator | Use of NIV on acute hypoxemic respiratory failure patients Receives: Device: Non-Invasive Mechanical Ventilation (NIV) |
| Group A2 (HFNC on hypoxemic) | Experimental | Use of HFNC on acute hypoxemic respiratory failure patients Receives: Device: High flow nasal cannula (HFNC) |
| Group B1 (NIVMV on hypercapneic) | Active comparator | Use of NIV on acute hypercapneic respiratory failure patients Receives: Device: Non-Invasive Mechanical Ventilation (NIV) |
| Group B2 (HFNC on hypercapneic) | Experimental | Use of HFNC on acute hypercapneic respiratory failure patients Receives: Device: High flow nasal cannula (HFNC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of HFNC and NIV in correction of Acidosis .
Evaluation of the effectiveness of HFNC VS NIV in correction of Acidosis through measurement of PH via arterial blood gases test (ABG).
Evaluation of the effectiveness of HFNC in correction of Acidosis through measurement of PH via arterial blood gases test (ABG).
Measured: Baseline
Evaluation of HFNC and NIV in correction of Hypercapnia.
Evaluation of the effectiveness of HFNC VS NIV in correction of Hypercapnia through measurement of PCO2 by mmHg via arterial blood gases test (ABG)
Measured: Baseline
Evaluation of HFNC and NIV in management of Acute hypoxemic respiratory failure.
Evaluation of the effectiveness of HFNC VS NIV in management of Acute hypoxemic respiratory failure through measurement of PO2 via arterial blood gases test (ABG)
Measured: Baseline
Evaluation of HFNC and NIV in correction of Hypoxemia.
Evaluation of the effectiveness of HFNC VS NIV in correction of Hypoxemia through measurement of O2 saturation by percentage % via pulse oximeter.
Measured: Baseline
Endotracheal intubation rate.
needs escalation to invasive mechanical ventilation
Measured: Baseline
Secondary outcomes (5)
In hospital mortality.
death
Measured: one month
duration of intervention
time needed for ventilatory support
Measured: one month
hospital coast
effects on hospital coast
Measured: one month
duration of ICU stay .
icu occupancy
Measured: one month
development of complications
due to devices
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start10 Oct 2022 (estimated)
- Primary completion10 Oct 2024 (estimated)
- Study completion20 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Hypoxemic 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Alham, Assiut University
- Investigators
- Zein Al-abdeen Ah Sayed, professor, Study director, Assiut UniversityTaghred SA Meshref, professor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499039
- Sponsor's protocol ID
- HFNC VS NIV
- Acronym
- Highflow
- Status last verified
- Aug 2022
- First submitted
- 7 Mar 2022
- Last updated
- 1 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Cannula Versus Non-Invasive (NIV)in Both Hypoxemic and Hypercapnic Respiratory Failure.
- ClinicalTrials.gov ID
- NCT05499039
- Acronym / sponsor ID
- Highflow / HFNC VS NIV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Oct 2022 (estimated)
- Primary completion
- 10 Oct 2024 (estimated)
- Study completion
- 20 Oct 2024 (estimated)
- First posted
- 12 Aug 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.
high flow nasal cannula (HFNC) oxygen therapy utilizes an air oxygen blend allowing from 21 % to 1 00% FiO2 delivery and generates up to 60 L/min flow rates The gas is heated and humidified through an active heated humidifier and delivered via a single limb heated inspiratory circuit (to avoid heat loss and condensation) to the patient through a large diameter nasal cannula Theoretically, HFNC offers significant advantages in oxygenation and ventilation over COT. Constant high flow oxygen delivery provides steady FiO2 and decreases oxygen dilution. It also washes out physiologic dead space and generates positive end expiration pressure (PEEP) that augments ventilation The heated humidification facilitates secretion clearance, decreases bronchospasm, and maintains mucosal integrity.
This study aims to evaluate the effectiveness of HFNC compared to NIMV in management of Acute hypoxemic and acute hypercapneic respiratory failure
Detailed description
- Acute respiratory failure (ARF) is a common and serious complication among hospitalized patients. It is the most frequent reason for admission to the intensive care unit (ICU) . It carries an in-hospital mortality rate of 20.6% and cost 54.3 billion dollars nationwide in United States in 2009. Among those patients with ARF, 42.1 % of patients require mechanical ventilation (MV), which is associated with a significant increase in both length of stay and medical expense
- ARF can be categorized into acute hypoxemic respiratory failure(AHRF) and acute hypercapneic respiratory failure.
- Supplemental oxygen and treatment of the underlying cause is the mainstay of therapy for AHRF. Options for oxygen therapy include conventional oxygen therapy delivered via nasal cannulae (NC) or face masks (FM) initially, followed by non-invasive ventilation (NIV), and finally intubation or mechanical ventilation (MV) .
- Traditional NC and FM (collectively referred to as conventional oxygen therapy or COT) can achieve flow rates of up to 1 5 L/min. However, these flow rates may be significantly lower than patients' spontaneous inspiratory flow rates and the oxygen is diluted as it is mixed with room air Consequently, the fraction of inspired oxygen (FiO2) delivered Is variable and this is thought to explain why many patients require an escalation of oxygen therapy to NIV or MV.
- By contrast, humidified high flow nasal cannula (HFNC) oxygen therapy utilizes an air oxygen blend allowing from 21 % to 1 00% FiO2 delivery and generates up to 60 L/min flow rates The gas is heated and humidified through an active heated humidifier and delivered via a single limb heated inspiratory circuit (to avoid heat loss and condensation) to the patient through a large diameter nasal cannula Theoretically, HFNC offers significant advantages in oxygenation and ventilation over COT. Constant high flow oxygen delivery provides steady FiO2 and decreases oxygen dilution. It also washes out physiologic dead space and generates positive end expiration pressure (PEEP) that augments ventilation The heated humidification facilitates secretion clearance, decreases bronchospasm, and maintains mucosal integrity
- HFNC has been well studied in the neonatal and pediatric settings However, in adults, the use of HFNC has Primarily been studied in post-cardiac surgery post-extubation and bronchoscopy patients. However, the utility of HFNC use in adults with AHRF in emergency and general inpatient practice is less clear .Heated and humidified high-flow oxygen through nasal cannula (HFNC) has been developed over the past 2 decades, as an alternative to standard oxygen delivery systems
- . In adults, it has been used to treat hypoxemic respiratory failure, cardiogenic pulmonary edema, postoperatively and postextubation in do-not-intubate patients or during bronchoscopy
- To date, the literature supports the possibility to use HFNC as alternative to non-invasive ventilation (NIV) in some settings, while in others might be even superior . It is also an alternative to standard oxygen as first line therapy in management of patients with acute respiratory failure . NIV is strongly recommended in patients with acute-on-chronic respiratory failure associated with acute respiratory acidosis, the vast majority of whom meet the criteria for Chronic Obstructive Pulmonary Disease (COPD) exacerbation
- Recently, Studies revealed no difference of the 30-day mortality and intubation rate between NIV and HFNC, in severe acute exacerbation of COPD with moderate, hypercapnic, acute respiratory failure. In a retrospective study, that suggeste that HFNC oxygen therapy was beneficial, even in respiratory failure Type 2, resulting in significant improvement of both oxygenation and hypercapnia. another study also indicated that HFNO leads to a flow-dependent reduction in PaCO2 in patients with stable hypercapnic COPD, due to a washout of the respiratory tract and a functional reduction in dead space
- Although cumulative evidence supports that HFNC is effective in patients with hypercapnia, randomized studies to compare HFNC vs. NIV in patients with acute, hypercapnic respiratory failure are missing. so the investigator conducting this prospective, randomized, controlled trial, involving patients admitted to the Emergency Department (ED), to compare the efficacy of HFNC versus NIV in the management of acute hypercapnic respiratory failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- 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 |
|---|---|---|
| Group A1 (NIVMV on hypoxemic) | Active comparator | Device: Non-Invasive Mechanical Ventilation (NIV)Use of NIV on acute hypoxemic respiratory failure patients |
| Group A2 (HFNC on hypoxemic) | Experimental | Device: High flow nasal cannula (HFNC)Use of HFNC on acute hypoxemic respiratory failure patients |
| Group B1 (NIVMV on hypercapneic) | Active comparator | Device: Non-Invasive Mechanical Ventilation (NIV)Use of NIV on acute hypercapneic respiratory failure patients |
| Group B2 (HFNC on hypercapneic) | Experimental | Device: High flow nasal cannula (HFNC)Use of HFNC on acute hypercapneic respiratory failure patients |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age above 18
- Acute hypoxemic respiratory failure. (Participants admitted with acute hypoxemic respiratory 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)
- Acute hypercapnic respiratory failure ((Participants admitted with acute hypercapneic respiratory with the following criteria:
Key exclusion criteria (12 listed)
- Patients with preprocedural or post-procedural settings (ex: surgery, bronchoscope) post- extubation,
- Patients with cancer or transplant patients,
- Patients less than 18 years old
- Patients with Heart failure patients
- Patients with renal failure patients
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 cannula (HFNC)Also: High velocity nasal insufflation (vapotherm)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% | Device | Group A2 (HFNC on hypoxemic), Group B2 (HFNC on hypercapneic) |
| Non-Invasive Mechanical Ventilation (NIV)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% Intervention: Device: non-invasive ventilation | Device | Group A1 (NIVMV on hypoxemic), Group B1 (NIVMV on hypercapneic) |
Primary outcome
Evaluation of HFNC and NIV in correction of Acidosis .
Time frame: Baseline
Evaluation of the effectiveness of HFNC VS NIV in correction of Acidosis through measurement of PH via arterial blood gases test (ABG). Evaluation of the effectiveness of HFNC in correction of Acidosis through measurement of PH via arterial blood gases test (ABG).
Evaluation of HFNC and NIV in correction of Hypercapnia.
Time frame: Baseline
Evaluation of the effectiveness of HFNC VS NIV in correction of Hypercapnia through measurement of PCO2 by mmHg via arterial blood gases test (ABG)
Evaluation of HFNC and NIV in management of Acute hypoxemic respiratory failure.
Time frame: Baseline
Evaluation of the effectiveness of HFNC VS NIV in management of Acute hypoxemic respiratory failure through measurement of PO2 via arterial blood gases test (ABG)
Evaluation of HFNC and NIV in correction of Hypoxemia.
Time frame: Baseline
Evaluation of the effectiveness of HFNC VS NIV in correction of Hypoxemia through measurement of O2 saturation by percentage % via pulse oximeter.
Endotracheal intubation rate.
Time frame: Baseline
needs escalation to invasive mechanical ventilation
5 secondary outcomes
In hospital mortality.
Time frame: one month
duration of intervention
Time frame: one month
hospital coast
Time frame: one month
duration of ICU stay .
Time frame: one month
development of complications
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- 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.
Peter At Rizk contact
Zein Al-abdeen Ah Sayed, professor study director
Assiut University
Taghred SA Meshref, professor 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 High flow nasal cannula (HFNC) and Non-Invasive Mechanical Ventilation (NIV) in people with Acute Hypoxemic Respiratory Failure and Acute Hypercapnic 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 6 inclusion and 12 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 1 Sep 2022. 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 Abdelrahman Mo Alham, Demonstrator (01014546379, abdoverno@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of HFNC and NIV in correction of Acidosis . (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2022.