Actively Recruiting
A Prospective Observational Study Evaluating Extubation Criteria in Children 10 Years and Younger Undergoing Intravenous Anesthesia
Led by Wake Forest University Health Sciences · Updated on 2025-12-18
600
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying extubation success in children under 10 years old who receive two different types of intravenous anesthesia: Total Intravenous Anesthesia (TIVA) and Sevoflurane Initiated Intravenous Anesthesia (SIIVA). These anesthesia methods work differently on the central nervous system and may require different criteria for safely removing breathing tubes after surgery. The study aims to understand which extubation criteria best predict success for these anesthesia types. The study observes two anesthesia techniques. TIVA uses only intravenous drugs without inhaled gases and is used if an IV line is in place before anesthesia starts. SIIVA begins with inhaled sevoflurane to induce anesthesia in patients who cannot tolerate IV insertion awake, then switches to intravenous propofol once the IV is placed and stops the inhaled gas. Both approaches are used during various surgeries requiring airway tubes. Participants will be monitored during and after surgery to see if extubation is successful on the first day and if any interventions are needed. Researchers will measure anesthetic gas concentrations to confirm appropriate emergence from anesthesia. The study collects data on extubation outcomes and airway management in children undergoing intravenous anesthesia. The total study period includes surgery and immediate recovery monitoring.
CONDITIONS
Brief Title
Total Intravenous Anesthesia (TIVA)/Sevoflurane Initiated Intravenous Anesthesia (SIIVA) in Pediatric Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pediatric patients younger than 10 years of age
- Undergoing elective or emergency surgery with planned airway instrumentation with an endotracheal tube (ETT)
- Patients having general anesthesia with a planned Sevoflurane Initiated Intravenous Anesthesia (SIIVA) or Total Intravenous Anesthesia (TIVA) technique
- Patients with an end tidal agent concentration of Sevoflurane less than 0.1% at the time of emergence and extubation following sevoflurane induction to place IV
You will not qualify if you...
- History of home oxygen use or ventilator dependence
- Patients with cyanotic congenital heart disease
- Patients undergoing anesthesia for imaging procedures alone
- Patients intended to be managed with supraglottic airway
- Patients having an anesthesia time less than 30 minutes
- Monitored Anesthesia Care (not general anesthesia)
- Patients with contraindication to receiving Propofol (i.e. mitochondrial myopathy)
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of surgery and anesthesia
Participants undergo anesthesia using either Total Intravenous Anesthesia (TIVA) or Sevoflurane Initiated Intravenous Anesthesia (SIIVA) during surgery with planned airway instrumentation.
1 surgical visit (in-person)
Duration - Day 1 post-surgery
Participants are observed for extubation success and any interventions needed following anesthesia.
1 follow-up visit (in-person)
Trial Site Locations
Total: 2 locations
1
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
2
Perth Children's Hospital
Perth, Australia
Not Yet Recruiting
Research Team
W
Wes Templeton, MD
L
Lynne Harris, BSN
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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