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Post Extubation Respiratory FailureNCT06593509

The Effectiveness of High Flow Nasal Cannula Versus Noninvasive Ventilation and Conventional Oxygen Therapy

A study testing Maquet,Servo I., Vapotherm and venturi mask in people with Post Extubation Respiratory Failure, run by Ain Shams 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

A prospective, randomized controlled study enrolling sixty patients who fulfilled weaning criteria after requiring invasive MV. After extubation, patients were randomized into three groups (20 patients per group) :NIV group , HFNC group, and COT group. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Post Extubation Respiratory Failure
What is being tested?
Maquet,Servo I., Vapotherm and venturi mask
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
20 Sep 2023to 20 Mar 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • adult patients (> 18 years)
  • who were mechanically ventilated longer than 12 hours for various respiratory indications
  • and planned for liberation from MV after fulfilling the criteria for weaning

Who cannot join

  • patients (<18 years )
  • Tracheostomized patients,
  • patients who were self-extubated or accidentally extubated,
  • Presence of contraindication to NIV : facial trauma, fracture or burn, pneumothorax, bronchopleural fistula, gastro/esophageal bleeding,
  • and patients who refused to participate in the study.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Respiratory intensive care unit , chest department faculty of medicine ain shams university

    Cairo, 1181

Other trials in Egypt

About this study

Official title: The Effectiveness of High Flow Nasal Cannula Versus Noninvasive Ventilation and Conventional Oxygen Therapy in Patients Weaned from Invasive Mechanical Ventilation:

A prospective, randomized controlled study enrolling sixty patients who fulfilled weaning criteria after requiring invasive MV. After extubation, patients were randomized into three groups (20 patients per group) :NIV group , HFNC group, and COT group. Primary outcomes included reintubation rates at certain time points and after 48 hours post-extubation while secondary outcomes included time to reintubation , ICU length of stay, ICU mortality. Objective: To compare the rate of reintubation within 48 hours after extubation among patients receiving NIV, HFNC and COT as post-extubation respiratory support.

Read the detailed description

Reintubation after liberation from mechanical ventilation (MV) is a wellknown adverse event seen in different patients subtypes(post surgical, trauma,medical) as well as in surgical and medical intensive care units (ICUs) .The cumulative probability of reintubation , following planned and unplanned extubation , in 185 ICUs in the United States ,reached up to 10 % and 90% occurred within the first 96 hours (4 days) after first extubation , the median time to reintubation was 15 hours.

Proper timing for extubation is crucial to minimize extubation failure and about 12 to 14% of patients planned for extubation would require reintubation within 48 to 72 hours, mostly within the first 24 hours \& in a multivariate analysis, duration of MV more than 7 days prior to extubation, ineffective cough, and severe systolic left ventricular dysfunction were independent factors associated with extubation failure, whereas ,in another study,age and underlying diseases were other factors associated with higher extubation failure with rates reaching up to 34% in patients 65 yrs or older, those with chronic respiratory or cardiac disorders and the condition was specifically associated with significant rapid clinical deterioration and worsening of daily organ dysfunction scores reflecting a direct effect of reintubation on patient outcomes. Mortality risk is reported to be five times higher in patients who require reintubation after extubation from MV.

Postextubation sequential oxygen devices applied as first-line therapy after extubation include noninvasive ventilation (NIV) , high-flow nasal cannula (HFNC) and conventional oxygen therapy (COT).

COT delivered via masks and nasal prongs has been widely used as the main sequential supportive oxygen therapy administered to patients after extubation . However, the maximal oxygen flow rates that these devices can deliver are limited with maximum flow rate up to 15 L/min only, which is usually far lower than the demands that postextubation patients would require . The fraction of inspired oxygen (FiO2) delivered by COT is unstable because of the entertainment of room air and dilution of the inspired oxygen .

Potential benefits of NIV include the ability to provide a relatively consistent and wider range of FiO2 compared with COT . Moreover, NIV creates an extrinsic positive end expiratory pressure which aids in recruitment of collapsed alveoli.

The American College of Chest Physicians/American Thoracic Society (ACCP/ATS) clinical practice guidelines for liberation from MV in the critically ill highlight the importance of usage of preventive (NIV) in patients at high risk of reintubation and emphasizing its impact on improving oxygenation, ventilation, decreasing hospital mortality, length of hospital stay, and incidence of ventilator associated pneumonia (VAP) . Evidence suggest that NIV may prevent postextubation respiratory failure and avoid reintubation if it is applied soon after extubation. On the other hand, this strategy is associated with worse outcomes if applied after development of postextubation acute respiratory failure (ARF). In addition, intolerance to NIV is quite common in clinical practice, eye irritation, skin damage, interruption in diet and clearance of airways secretion are common adverse events and can worsen the patient's outcome. These limitations urge investigators to explore other alternative oxygen delivery devices and search for potential roles in improving clinical outcomes in the post extubation setting.

High flow nasal cannula (HFNC) is a novel, high flow oxygen device with established efficiency, it is well tolerated by patients, easily applied and can provide fully humidified, heated, high-flow rates up to 60 L/min, a constant high fraction of inspired oxygen (FiO2) (0.21 - 1.0) and flow-dependent continuous positive airway pressure (2-5 cm H2O) which , in turn , increases end-expiratory lung volume and aids in alveolar recruitment and reduces atelectasis, subsequently improving ventilation-perfusion mismatch . The continuous high flow of oxygen guarantees both higher tidal volume with adequate minute ventilation and sufficient oxygenation improves inspiratory flow dynamics and decrease work of breathing by improving thoracoabdominal synchrony. In addition, pharyngeal dead space washout effect decreases carbon dioxide in a faster manner. Finally, the heated humidification flow creates physiological conditions preserving mucosal integrity, reducing mucosal inflammation, and facilitating clearance of secretions, thereby improving the oxygenation, and further decreasing the risk of atelectasis.

Several studies have investigated these available devices and compared their efficacy in lowering reintubation rates after extubation, but results are conflicting and inconsistent and no study could conclude that either HFNC, NIV or COT is superior to prevent reintubation. One randomized controlled trial (RCT) reported that HFNC was associated with a lower rate of reintubation in low-risk patients compared to COT. Another RCT in high-risk non-hypercapnic patients and concluded that HFNC could not decrease rate of reintubation compared with COT. A third study showed that HFNC and NIV are equally effective in lowering reintubation rate.

In Egypt, researchers have also studied and compared the effectiveness of these modalities in different clinical ICU settings with comparable efficacies between three devices. The objective of the current work is to compare the rate of reintubation after extubation using HFNC versus NIV and COT as sequential respiratory support.

Being tested
Maquet,Servo I., Vapotherm, venturi mask
Keywords
weaning., Mechanical ventilation, COT, HFNC, NIV

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Maquet,Servo I.Device

    Model number: 06487800, Serial Number: 19761, SKU#: Inv-00344191, Made in Sweden

  • VapothermDevice

    INC ,100 domain drive Exeter, NH 03833, Made in U.S.A

  • venturi maskDevice

    Intersurgical Ltd, Crane House, Molly Millars Lane, Wokingham, Berkshire, RG41 2RZ, UK.,REF. 1107085, LOT,31757961

Study groups in NCT06593509
Study groupRoleWhat they receive
Non-invasive mechanical ventilationExperimentalDevice: Non-invasive mechanical ventilation Bilevel pressure support through a face mask
Receives: Device: Maquet,Servo I.
High Flow Conditioned Oxygen TherapyExperimentalDevice: High Flow Conditioned Oxygen device vapotherm via nasal cannula
Receives: Device: Vapotherm
Conventional Oxygen TherapyActive comparatorDevice: Conventional Oxygen Therapy conventional Oxygen Therapy with Venturi facial mask.
Receives: Device: venturi mask

What is being measured

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

  1. reintubation rate(N,%)

    reintubation after extubation

    Measured: 48 hours

Secondary outcomes (2)
  1. intensive care unit length of stay(days)

    duration of stay in intensive care unit

    Measured: one month

  2. intensive care unit mortality rate(N,%)

    mortality inside intensive care unit

    Measured: one month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start20 Sep 2023
  3. Primary completion20 Mar 2024
  4. Study completion20 Mar 2024

Resources

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
Parallel Assignment
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06593509
Sponsor's protocol ID
FMASU MS 443/2023
Status last verified
Aug 2023
First submitted
23 Aug 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Maquet,Servo I., Vapotherm and venturi mask in people with Post Extubation Respiratory Failure, run by Ain Shams 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 3 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: finished, as of the sponsor's last update on 19 Sep 2024. 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?

reintubation rate(N,%) (time frame: 48 hours). 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 19 Sep 2024.

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