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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • Faculty of medicine

    Banī Suwayf, Beni Suweif Governorate

Other trials in Egypt

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:

  1. History taking: Full history was Taken from the patients' close relatives including personal data and a detailed medical history.
  2. Full clinical assessment: All patients were subjected to full clinical examination including general and chest examination.
  3. Investigations :
  4. 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
  1. Radiological:
  • Chest X-ray on admission \& as required for follow up.
  • Additional imaging according to clinical judgment as (CT chest, chest u/s )
  1. 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 .

  1. 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.

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 groups in NCT05698641
Study groupRoleWhat they receive
HFNCPatients treated with HFNC
NIVPatients treated with NIV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. failure of treatment modality

    failure of improvement of PH

    Measured: 1 hour

Secondary outcomes (2)
  1. mortality

    patient death during icu stay

    Measured: 28 day

  2. 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.

  1. First posted26 Jan 2023
  2. Study start1 Sep 2020
  3. Primary completion1 Feb 2022
  4. Study completion1 Feb 2022

Resources

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)
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

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.

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