None listed
Conditions
Brief summary
Endotracheal suctioning (ETS) is an essential nursing and physiotherapy activity in intensive care that needs to be frequently repeated in intubated patients to reduce morbidity associated with invasive ventilation. However, research has shown that ETS can have considerable negative impact on many physiological variables, including the intracranial pressure (ICP) and cerebral perfusion pressure (CPP) of head-injured patients. Studies in adults have demonstrated a significant supression of ICP elevation with lidocaine administered intratracheally. However, there is a lack of pediatric studies assessing the issue of endotracheal lidocaine instillation for blunting endotracheal suctioning-induced ICP changes. The primary objective of this study is to evaluate the effectiveness of endotracheal lidocaine instillation at dosage of 1.5 mg/kg in reducing the increase of ICP after a single endotracheal suctioning in severe head-injured children.
Interventions
Intervention: 2% lidocaine
Doses: lidocaine 1.5 mg/kg added to normal saline (total volume of 5 mL)
Mode of administration: endotracheal instillation
Duration: instillation at 1 ml/s rate
Each study will be performed in duplicate, once after endotracheal lidocaine instillation and once after instillation of an equal volume of a normal saline in a double-blind crossover fashion. Lidocaine and saline will be instilled at body temperature through a 4-French fine tube advanced into the endotrac
Intervention: 2% lidocaine Doses: lidocaine 1.5 mg/kg added to normal saline (total volume of 5 mL) Mode of administration: endotracheal instillation Duration: instillation at 1 ml/s rate Each study will be performed in duplicate, once after endotracheal lidocaine instillation and once after instillation of an equal volume of a normal saline in a double-blind crossover fashion. Lidocaine and saline will be instilled at body temperature through a 4-French fine tube advanced into the endotracheal tube within its length, near the carina. Approximately 30-60 secs prior to suctioning procedure, the delivery of FiO2 will be increased to 100% while the ventilator settings will remain unchanged. After endotracheal lidocaine or saline solution instillation a 3 min interval will be allowed prior to the suctioning event which will be performed in a single pass using an closed-system suctioning (with an appropriate diameter of the suction catheter, negative pressure of 80-100 mmHg, and total duration of < 15 secs). Inspired oxygen fraction (FiO2)will remain at 100% for 60 secs following the suctioning event then will be returned to the preprocedural level (baseline). After a 3 hour-washout period the crossover solution will be then administered
Sponsors
Paulo Sergio Lucas da Silva
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
1 Months to 16 Years
Healthy volunteers
No
Inclusion criteria
Patients presenting severe closed-head injury presenting the following: a) age younger than 16 years, b) Glasgow Coma Scale score 4-8 and intracranial pressure monitoring, c) hemodynamic status stable and, d) within 72 hours from admission.
Exclusion criteria
Intracranial hypertension (intracranial pressure > 20 mmHg), hepatic disease and, patients with acute lung injury (PaO2/FiO2 < 300).
Outcome results
None listed