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Extubation FailureNCT06557941

Risk Factors of Extubation Failure in PICU Patients

An observational study of Extubation Failure, run by Sohag University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Up to 20% of MV patients experience EF [10]. EF is defined as the need to reinsert the endotracheal tube to resume MV in patients extubated for less than 48 hours. It has high rates of morbidity and mortality, prolongs the duration of MV and thus causes a longer stay in the PICU and risk of complications such as the… Read more about this study

Who is it for?
Ages 30 days to 18 years
Conditions the study is for
Extubation Failure
How many people
100 participants
Where
1 siteEgypt
Study dates
1 May 2024to May 2025
How long will I take part?
30 Days
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 30 days to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: Patients in PICUS in Sohag University Hospitals.

Who may be able to join

  • All patient at PICU < 18 years subjected to MV through an endotracheal tube at least >12 hours.
  • Patients eligible for weaning from MV according to the weaning criteria (Evidence for some reversal of the underlying cause following for respiratory failure, Adequate oxygenation" PaO2/FIO2 ratio ≥ 200, FIO2 ≤ 0.40, PaO2 ≥ 60, PaCO2 ≤ 60 and PEEP ≤ 5 cmH2O.", PH ≥ 7.25, Respiratory rate (RR) ≤ 45 bpm, Heart rate (HR) ≤ 140 bpm,(rapid shallow breathing index = tidal volume / RR) RSBI ≤ 8 breaths/min/ml/kg body weight, Hemodynamic stable, no or minimal vasopressor or inotropes"[1,12],.
  • Appropriate level of consciousness, No continuous sedation infusion nor neuromuscular blocking agents, afebrile, adequate hemoglobin ≥ 7.5 g/dl and/or no evidence of hemorrhage.

Who cannot join

  • Patients less than 30 days.
  • Tracheostomized patients.
  • Death on mv ≤ 12 hours.
  • Unplanned extubation.

Trial locations and contacts

1 site in 1 country.

mariam raafat helmy, postgraduate contact

01284134530

mariam.rafaat@med.sohag.edu.eg

Egypt1 site, 1 recruiting
  • Sohag University Hospitals

    Sohag

    Magdy M Amin

    Recruiting

Other trials in Egypt

About this study

Official title: The Risk Factors of Extubation Failure in Pediatric Intensive Unite Patients at Sohag University Hospitals

Up to 20% of MV patients experience EF [10]. EF is defined as the need to reinsert the endotracheal tube to resume MV in patients extubated for less than 48 hours. It has high rates of morbidity and mortality, prolongs the duration of MV and thus causes a longer stay in the PICU and risk of complications such as the need for tracheostomy, the incidence of pneumonia and pulmonary damage, and finally, costs increase as well and death [10, 11] .

Read the detailed description

Mechanical ventilation (MV) is a common life support modality in 40% of pediatric intensive care unit (PICU) patients. The process of ventilatory support follows a continuum of care, beginning with the patient requiring initial support and ending with the ability to sustain spontaneous breathing [1].

Although MV is a cornerstone in critical care medicine, risks and complications associated with prolonged MV include ventilator associated pneumonia (VAP), barotrauma / volutrauma, decreased cardiac filling, ventilator associated diaphragmatic dysfunction and sepsis [6, 8].

Previous studies recommend extubating patient as early as possible according to clinical course and reversal of the leading causes of intubation. The process of extubation consists of the removal of the endotracheal tube when the patient's physiological status recovers allowing the patient to maintain spontaneous breathing [3,4].

Weaning from MV and extubation are vital steps in patients' recovery; however, these steps are associated with significant risks. Balancing the hazards of premature extubation such as extubation failure (EF) and emergent reintubation with those of prolonged MV is a challenge. [4,5] There is currently a paucity of published evidence-based protocols or guidelines to guide this process; therefore, predictors for successful extubation in critically ill children are not always clear cut. This has resulted in wide variation in practice amongst (PICU) providers that is typically based on institutional norms [4,5, 6]. The most common approach to weaning infants and children is gradual reduction of ventilatory settings not requiring changing the ventilator mode [12].

Up to 20% of MV patients experience EF [10]. EF is defined as the need to reinsert the endotracheal tube to resume MV in patients extubated for less than 48 hours. It has high rates of morbidity and mortality, prolongs the duration of MV and thus causes a longer stay in the PICU and risk of complications such as the need for tracheostomy, the incidence of pneumonia and pulmonary damage, and finally, costs increase as well and death [10, 11] .

At present , several pediatric studies have shown the predictive factors associated with EF ; longer duration of MV ≥7 days and PICU admission ≥ one month , age under one year , malnutrition, respiratory and chronic neurological deterioration , use of sedatives by infusion ≥ 5 days and inotropes ≥ 10 days[6,8] , improper evaluation for extubation readiness , post extubation upper airway obstruction and stridor, residual muscle weakness , pulmonary edema , weak cough reflex[9, 10] , use of uncuffed endotracheal tube , presence of any metabolic and electrolyte imbalances and high ventilator settings prior to extubation [11].

Therapeutic respiratory support, including noninvasive positive pressure ventilation and high-flow nasal cannula, appears to help reduce the need for reintubation in the majority of patients experiencing post extubation respiratory failure. however, Neurologic patients seem to be at higher risk of reintubation despite NIV use [6,13].

Previous researches were carried out in some Egyptian PICUs to investigate the incidence and potential risk factors of EF [1,2,3]. Mahmoud demonstrated that about third of mechanically-ventilated patients in the study experienced EF [2]. Another study showed that the need for longer periods of sedation and high setting on MV in addition to excess tracheal secretions were among strong predictors for EF [3]. Moreover, previous research in our PICU indicated that mortality was high up to 40% [16]. Therefore, investigating the causes of EF in our unit might help in reducing mortality. Furthermore, establishing local protocol of gradual and correct weaning can decrease the risk of EF in our unit.

Keywords
extubation failure, mechanical ventilation, PICU

What participants receive

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

Study groups in NCT06557941
Study groupRoleWhat they receive
A:successful extubationmechanically ventilated PICU patients who pass spontaneous breathing trial and air leak test , extubated and not requiring to be re-intubated within 48 hours.
B: failed extubationmechanically ventilated PICU patients who don't pass spontaneous breathing trial and air leak test , extubated and requiring to be re-intubated within 48 hours.

What is being measured

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

  1. successful extubation and weaning from mechanical ventilation

    passing spontaneous trial and air leak test and not requiring to be re-intubated within 2 days

    Measured: 48 hours

  2. failed extubation , failed weaning from mechanical ventilation

    not passing spontaneous trial and air leak test and not requiring to be re-intubated within 2 days

    Measured: 48 hours

Secondary outcomes (1)
  1. survival or death

    weaning from mechanical ventilation and improvement of the cause of intubation

    Measured: 30 days

Timeline

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

  1. First posted16 Aug 2024
  2. Study start1 May 2024
  3. Primary completionMay 2025 (estimated)
  4. Study completionMay 2025 (estimated)

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 (estimated)
Target duration
30 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT06557941
Sponsor's protocol ID
Soh-Med-24-07-11MS
Status last verified
Aug 2024
First submitted
14 Aug 2024
Last updated
16 Aug 2024
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Extubation Failure, run by Sohag 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 4 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 16 Aug 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact mariam raafat helmy, postgraduate (01284134530, mariam.rafaat@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

successful extubation and weaning from mechanical ventilation (time frame: 48 hours). The study lists 2 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 16 Aug 2024.

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