Type 2 Respiratory FailureNCT05698641
Efficiency of HFNC Vs NIV in Patient With Acute Type 2 RF
An observational study of Type 2 Respiratory Failure, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Background: In acute hypoxic respiratory failure, high-flow nasal cannula (HFNC) oxygen treatment is gaining popularity. However, there is just a small body of research to back up the use of HFNC in acute respiratory failure (ARF) with hypercapnia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Respiratory Failure
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 1 Feb 2022
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients of both sex who were admitted to ICU with acute moderate hypercapnic respiratory failure. Included patients were divided into two groups: * Group A: 50 patients with acute moderate hypercapnic respiratory failure who were treated with HFNC as ventilatory support . * Group B: 50 patients with acute moderate hypercapnic respiratory failure who were treated with NIV as ventilatory support .
Who may be able to join
None listed.
Who cannot join
- Patients aged <18 years
- Patients with altered consciousness defined by a Glasgow coma score of >12 points.
- Hemodynamic instability defined by systolic arterial blood pressure 90 mmHg, mean arterial blood pressure 65 mm Hg, on vasopressor, confusion , chest pain or loss of consciousness )
- PH>7.25
- Patients who need immediate endotracheal intubation.
- Contraindication to NIV (oral and facial trauma, excessive phlegm with poor expectoration ability, vomiting and Epistaxis)
- Post cardiac arrest patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Efficiency of High Flow Nasal Cannula Versus Noninvasive Ventilation in Patients With Acute Hypercapnic Respiratory Failure
Background: In acute hypoxic respiratory failure, high-flow nasal cannula (HFNC) oxygen treatment is gaining popularity. However, there is just a small body of research to back up the use of HFNC in acute respiratory failure (ARF) with hypercapnia.
Aim of study: To evaluate the effectiveness of high-flow nasal cannula (HFNC) in reducing the rate of endotracheal intubation and PCO2 level in adult patients with Acute moderate type II respiratory failure in comparison to noninvasive positive pressure ventilation (NIPPV).
Methods : A randomized control trial that was conducted on patients with acute moderate hypercapnic respiratory failure ARF (arterial blood gases pH 7.25-7.35, PaCO2>45 mmHg) who were admitted to respiratory and medical critical care units from September 2020 through February 2022 and received HFNC or NIV .The endpoint was treatment failure, which was indicated by either invasive ventilation or mortality .
Read the detailed description
Adult patients of both sex who were admitted to ICU with acute moderate hypercapnic respiratory failure.
Included patients were divided into two groups:
- Group A: 50 patients with acute moderate hypercapnic respiratory failure who were treated with HFNC as ventilatory support .
- Group B: 50 patients with acute moderate hypercapnic respiratory failure who were treated with NIV as ventilatory support .
Device used:
- For group A (HFNC) : we used either Airvo 2 Manufacturer: Fisher \&Paykel Co. , Precision flow Hi - VNI ™ (Vapotherm ) or built in HFNC mode in (e Volution ventilator ) .
- For group B (NIV) :we used Puritan Bennett™ 840 Ventilator and the used interface was oro nasal mask of fitting size to each patient .
All patients included in the study will be subjected to the following:
- History taking: Full history was Taken from the patients' close relatives including personal data and a detailed medical history.
- Full clinical assessment: All patients were subjected to full clinical examination including general and chest examination.
- Investigations :
- Laboratory:
- Routine laboratory investigations including : (CBC, Na , K ,Urea ,Creatinine , AST,ALT, Albumin , INR,…… ( .
- ABG: on admission \& as required for follow up.
- Pulmonary function test that was previously done 3 to 6 months before the study if available
- Radiological:
- Chest X-ray on admission \& as required for follow up.
- Additional imaging according to clinical judgment as (CT chest, chest u/s )
- Intervention:
- We included all admitted adult patients in ICU with Acute moderate Hypercapnic patient PH: >7.25 and <7.35 and PCO2>45mmHg.
During the intervention all the included patients were treated in a randomized one to one selection according to inclusion and exclusion criteria.with either non-invasive ventilation (NIV), or with high-flow nasal cannula (HFNC). Both groups were treated in usual manner of drug therapy according to their diseases etiology .
- Group A : High-flow-oxygen group High flow nasal cannula was applied continuously through (Airvo 2 device manufactured by Fisher \& Paykel Healthcare, Auckland, New Zealand or Precision flow Hi - VNI ™ (Vapotherm ) and built in HFNC mode in (e Volution ventilator ). The fraction of oxygen in the gas flowing in the system was subsequently adjusted to maintain SpO2 of 88-92%. High-flow oxygen was applied for at least 4 h per day.initial flow rate 40 liter /minute when PH 7.30-7.35 and more than 40 liter / minute when PH 7.25-7.29. Temperature was initially set to 37°C unless reported too hot by patients at initiation.
Close monitoring and follow up for weaning based on the patient response represented by the respiratory parameters, patient comfort and arterial blood gases .
Group B: Noninvasive-ventilation group:
Noninvasive ventilation was applied to the patient through a oronasal mask connected to an ICU ventilator.
The pressure-support level was adjusted with the aim of obtaining tidal volume of 6 to 8 ml per kilogram of predicted body weight , PEEP adjusted to be 5 cm of water. The FiO2 was adjusted to maintain SpO2 of 88-92% .
The minimally required duration of noninvasive ventilation was 4 hours per day. Noninvasive ventilation was be applied in sessions of at least 2 hour and could be resumed if the respiratory rate was more than 30 breaths per minute or the SpO2 was less than 88%.
All ventilator settings were re-adjusted based on the results of continuous oximetry, measurements of arterial blood gases and ventilator parameters (tidal volume, respiratory rate, and mask leakage) as well as on the comfort of patient.
When FiO2 was lower than 30 %, tidal volume higher than 6 mL/kg of predicted body weight with a pressure support equal or lower than 8 cm H2O and PEEP level at 5 cm H2O, NIV withdrawal was started and conventional oxygen therapy was applied continuously through nasal cannula or oxygen facemask.
- Conditions
- Type 2 Respiratory Failure
- Keywords
- type2 RF, HFNC, NIV
- Medical subject headings
- Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HFNC | Patients treated with HFNC | |
| NIV | Patients treated with NIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
failure of treatment modality
failure of improvement of PH
Measured: 1 hour
Secondary outcomes (2)
mortality
patient death during icu stay
Measured: 28 day
ICU stay
time stay of icu
Measured: 28 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Sep 2020
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gehad Ahmed Ali, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698641
- Sponsor's protocol ID
- FMBSUREC/01092020/Ali
- Status last verified
- Jan 2023
- First submitted
- 12 Jan 2023
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficiency of High Flow Nasal Cannula Versus Noninvasive Ventilation in Patients With Acute Hypercapnic Respiratory Failure
- ClinicalTrials.gov ID
- NCT05698641
- Acronym / sponsor ID
- FMBSUREC/01092020/Ali
- Conditions
- Type 2 Respiratory Failure
- Keywords
- type2 RF, HFNC, NIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 26 Jan 2023 (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.
Background: In acute hypoxic respiratory failure, high-flow nasal cannula (HFNC) oxygen treatment is gaining popularity. However, there is just a small body of research to back up the use of HFNC in acute respiratory failure (ARF) with hypercapnia.
Aim of study: To evaluate the effectiveness of high-flow nasal cannula (HFNC) in reducing the rate of endotracheal intubation and PCO2 level in adult patients with Acute moderate type II respiratory failure in comparison to noninvasive positive pressure ventilation (NIPPV).
Methods : A randomized control trial that was conducted on patients with acute moderate hypercapnic respiratory failure ARF (arterial blood gases pH 7.25-7.35, PaCO2>45 mmHg) who were admitted to respiratory and medical critical care units from September 2020 through February 2022 and received HFNC or NIV .The endpoint was treatment failure, which was indicated by either invasive ventilation or mortality .
Detailed description
Adult patients of both sex who were admitted to ICU with acute moderate hypercapnic respiratory failure.
Included patients were divided into two groups:
- Group A: 50 patients with acute moderate hypercapnic respiratory failure who were treated with HFNC as ventilatory support .
- Group B: 50 patients with acute moderate hypercapnic respiratory failure who were treated with NIV as ventilatory support .
Device used:
- For group A (HFNC) : we used either Airvo 2 Manufacturer: Fisher \&Paykel Co. , Precision flow Hi - VNI ™ (Vapotherm ) or built in HFNC mode in (e Volution ventilator ) .
- For group B (NIV) :we used Puritan Bennett™ 840 Ventilator and the used interface was oro nasal mask of fitting size to each patient .
All patients included in the study will be subjected to the following:
- History taking: Full history was Taken from the patients' close relatives including personal data and a detailed medical history.
- Full clinical assessment: All patients were subjected to full clinical examination including general and chest examination.
- Investigations :
- Laboratory:
- Routine laboratory investigations including : (CBC, Na , K ,Urea ,Creatinine , AST,ALT, Albumin , INR,…… ( .
- ABG: on admission \& as required for follow up.
- Pulmonary function test that was previously done 3 to 6 months before the study if available
- Radiological:
- Chest X-ray on admission \& as required for follow up.
- Additional imaging according to clinical judgment as (CT chest, chest u/s )
- Intervention:
- We included all admitted adult patients in ICU with Acute moderate Hypercapnic patient PH: >7.25 and <7.35 and PCO2>45mmHg.
During the intervention all the included patients were treated in a randomized one to one selection according to inclusion and exclusion criteria.with either non-invasive ventilation (NIV), or with high-flow nasal cannula (HFNC). Both groups were treated in usual manner of drug therapy according to their diseases etiology .
- Group A : High-flow-oxygen group High flow nasal cannula was applied continuously through (Airvo 2 device manufactured by Fisher \& Paykel Healthcare, Auckland, New Zealand or Precision flow Hi - VNI ™ (Vapotherm ) and built in HFNC mode in (e Volution ventilator ). The fraction of oxygen in the gas flowing in the system was subsequently adjusted to maintain SpO2 of 88-92%. High-flow oxygen was applied for at least 4 h per day.initial flow rate 40 liter /minute when PH 7.30-7.35 and more than 40 liter / minute when PH 7.25-7.29. Temperature was initially set to 37°C unless reported too hot by patients at initiation.
Close monitoring and follow up for weaning based on the patient response represented by the respiratory parameters, patient comfort and arterial blood gases .
Group B: Noninvasive-ventilation group:
Noninvasive ventilation was applied to the patient through a oronasal mask connected to an ICU ventilator.
The pressure-support level was adjusted with the aim of obtaining tidal volume of 6 to 8 ml per kilogram of predicted body weight , PEEP adjusted to be 5 cm of water. The FiO2 was adjusted to maintain SpO2 of 88-92% .
The minimally required duration of noninvasive ventilation was 4 hours per day. Noninvasive ventilation was be applied in sessions of at least 2 hour and could be resumed if the respiratory rate was more than 30 breaths per minute or the SpO2 was less than 88%.
All ventilator settings were re-adjusted based on the results of continuous oximetry, measurements of arterial blood gases and ventilator parameters (tidal volume, respiratory rate, and mask leakage) as well as on the comfort of patient.
When FiO2 was lower than 30 %, tidal volume higher than 6 mL/kg of predicted body weight with a pressure support equal or lower than 8 cm H2O and PEEP level at 5 cm H2O, NIV withdrawal was started and conventional oxygen therapy was applied continuously through nasal cannula or oxygen facemask.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFNC | – | –Patients treated with HFNC |
| NIV | – | –Patients treated with NIV |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients of both sex who were admitted to ICU with acute moderate hypercapnic respiratory failure. Included patients were divided into two groups: * Group A: 50 patients with acute moderate hypercapnic respiratory failure who were treated with HFNC as ventilatory support . * Group B: 50 patients with acute moderate hypercapnic respiratory failure who were treated with NIV as ventilatory support .
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Patients aged <18 years
- Patients with altered consciousness defined by a Glasgow coma score of >12 points.
- Hemodynamic instability defined by systolic arterial blood pressure 90 mmHg, mean arterial blood pressure 65 mm Hg, on vasopressor, confusion , chest pain or loss of consciousness )
- PH>7.25
- Patients who need immediate endotracheal intubation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
failure of treatment modality
Time frame: 1 hour
failure of improvement of PH
2 secondary outcomes
mortality
Time frame: 28 day
ICU stay
Time frame: 28 day
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 26 Jan 2023.
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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?
An observational study of Type 2 Respiratory Failure, run by Beni-Suef 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 0 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 26 Jan 2023. 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?
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?
failure of treatment modality (time frame: 1 hour). 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 26 Jan 2023.