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.
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.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospitals
Sohag
Magdy M Amin
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.
- Conditions
- Extubation Failure
- 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 group | Role | What they receive |
|---|---|---|
| A:successful extubation | mechanically 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 extubation | mechanically 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.
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
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)
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.
- First posted16 Aug 2024
- Study start1 May 2024
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extubation FailureStudies of the same condition, open and under way.
- More trials run by Sohag 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 (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Rafaat Helmy, Sohag University
- Investigators
- Mostafa Ashry Mohamed, assistant professeer, Study director, pediatrics department faculty of medicine sohag universityRania Gamal Mostafa Abdelatif, lecturer, Study director, pediatrics department faculty of medicine sohag university
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Risk Factors of Extubation Failure in Pediatric Intensive Unite Patients at Sohag University Hospitals
- ClinicalTrials.gov ID
- NCT06557941
- Acronym / sponsor ID
- Soh-Med-24-07-11MS
- Conditions
- Extubation Failure
- Keywords
- extubation failure, mechanical ventilation, PICU
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 16 Aug 2024 (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.
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] .
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A:successful extubation | – | –mechanically 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 extubation | – | –mechanically ventilated PICU patients who don't pass spontaneous breathing trial and air leak test , extubated and requiring to be re-intubated within 48 hours. |
Who may qualify
- Ages
- 30 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients in PICUS in Sohag University Hospitals.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Patients less than 30 days.
- Tracheostomized patients.
- Death on mv ≤ 12 hours.
- Unplanned extubation.
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
successful extubation and weaning from mechanical ventilation
Time frame: 48 hours
passing spontaneous trial and air leak test and not requiring to be re-intubated within 2 days
failed extubation , failed weaning from mechanical ventilation
Time frame: 48 hours
not passing spontaneous trial and air leak test and not requiring to be re-intubated within 2 days
1 secondary outcome
survival or death
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
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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.
Mostafa Ashry Mohamed, assistant professeer study director
pediatrics department faculty of medicine sohag university
Rania Gamal Mostafa Abdelatif, lecturer study director
pediatrics department faculty of medicine sohag university
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 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.