Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06557941
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Risk Factors of Extubation Failure in PICU Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Risk Factors of Extubation Failure in Pediatric Intensive Unite Patients at Sohag University Hospitals
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 patients physiological status recovers allowing the patient to maintain spontaneous breathing 34
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 45 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 45 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 days68 improper evaluation for extubation readiness post extubation upper airway obstruction and stridor residual muscle weakness pulmonary edema weak cough reflex9 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 613
Previous researches were carried out in some Egyptian PICUs to investigate the incidence and potential risk factors of EF 123 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
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 patients physiological status recovers allowing the patient to maintain spontaneous breathing 34
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 45 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 45 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 days68 improper evaluation for extubation readiness post extubation upper airway obstruction and stridor residual muscle weakness pulmonary edema weak cough reflex9 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 613
Previous researches were carried out in some Egyptian PICUs to investigate the incidence and potential risk factors of EF 123 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None