Anesthesia, Pediatric Clinical Trial
Official title:
A Direct Comparison of Predictors for Extubation in Children Less Than 7 Years Old Undergoing Anesthesia: A Prospective Observational Study
The timing of extubation following surgery and anesthesia in young children is a complex
decision frequently guided by the experience of the clinician. The clinician frequently must
make a decision based on assimilating multiple cues that may or may not demonstrate that the
patient is ready for extubation such as eye opening, conjugate gaze, spontaneous ventilation,
and end tidal agent concentration. At this time there is no published data on the predictive
ability of individual extubation criteria for young patients undergoing anesthesia for
surgery so most practice is based solely on experience and anecdotal teaching. In some cases
if the timing is misjudged and the patient is extubated too early negative airway reflexes
such as breath holding and laryngospasm may take over creating a critical situation in which
the patient forgoes gas exchange and rapidly desaturates with the potential for bradycardia
and further cardiovascular collapse.
Routine criteria used to determine fitness for extubation have been primarily described in
the intensive care unit literature and may be less relevant in the operating room in the
setting of routine general anesthetics. Most predictors including adequate tidal volume,
presence of conjugate gaze, eye opening, patient movement purposeful or otherwise, low end
tidal anesthetic agent concentration, response to physical or verbal stimulation and the
laryngeal stimulation test have not previously been evaluated to determine their individual
predictive value in deciding if the presently anesthetized patient now emerging is ready to
be extubated.
In order to perform a laryngeal stimulation test the patient must be breathing spontaneously
and practitioner will gently move the endotracheal tube up and down stimulating the larynx.
In patients in stage 2 of anesthesia, the clinician will typically observe a cough or series
of coughs followed by a respiratory pause of greater than 5 seconds. In this situation the
patient has not adequately passed through stage 2 and remains at increased risk for apnea,
breath holding, or laryngospasm. If the patient is in stage 1 of anesthesia the clinician
will observe a cough followed by a brief pause (less than 5 seconds) or almost immediate
return to spontaneous ventilation.
In conclusion, their exist no quantitative data on the predictive value of these various
criteria for extubation and the goal of our study is determine the indivdual predictive value
of different criteria in determing fitness for extubaion in young pediatric patients by
recording the presence or absence of various criteria in pediatric patients at the time of
extubation during routine anesthetic care.
Objectives
The objective of this study is to prospectively observe the frequency and predictive value of
specific signs and criteria and correlate those with successful extubation in young children
to determine which are present with the greatest frequency and which signs are most
predictive of successful extubation.
Methods and Measures
Design
A trained observer will prospectively observe emergence and extubation in pediatric patients
between the ages of less than 7 years of age in which potent inhalational agents were used
for anesthetic maintenance. They will record the presence or absence of certain accepted
signs that a young child is ready for extubation such as eye opening, postive larygneal
stimulation test, purposeful movement, end tidal agent concentration, and several others (see
Appendix 1 for complete list). We will also record the use of nondepolarizing neuromuscular
blocking drugs, use and presence of train of four monitoring, and end tidal carbon dioxide
concentration at the time of extubation. Timing of extubation will be at the discretion of
the attending anesthesiologist caring for the patient according to their usual practice.
Following extubation we will observe the patient and a second checklist will be filled out
detailing any events such as the need for continuous positive pressure with 100% oxygen,
reintubation. The quality of extubation will be scored as either "successful," "moderately
successful," or "failed," according to predefined criteria; see appendix 1.The investigators
will record the oxygen saturation, respiratory rate, and presence or absence of additional
oxygen supplementation such as "blow by," "mask oxygen" or "nasal cannula" on arrival to the
Post anesthesia care unit, at 5, 10, and 30 minutes after arrival in the post anesthesia care
unit. The investigators will also record the post anesthesia care unit length of stay as
defined as the time at arrival until the time the nurse deems that the patient has recovered
sufficiently to leave the post anesthesia care unit either for home or for their inhouse bed.
Investigators will record age, height, weight, gender, American society of anesthesiologist
status, type of surgery, and presence or absence of any upper respiratory infection symptoms
in the previous 2 weeks, and any premedication, type of inhalational agent used.
Investigators will observe patients less than 7 years old based on the operating room
schedule.
The study will be performed at Wake Forest Baptist Medical Center a tertiary academic medical
center.
Subjects selection criteria
Pediatric patients under the age of 7 scheduled for surgery and anesthesia with an
endotracheal tube will be observed at the time of extubation.
• Inclusion Criteria
Patients less than 7 years of age scheduled for surgery and anesthesia in which an
endotracheal tube is placed for airway management and potent inhalational agents are used for
anesthetic maintenance for which a trained study observer can be present for extubation will
be included.
• Exclusion Criteria
Patients using a laryngeal mask airway or other supralaryngeal device for airway management
during an elective procedure.
Patients with a tracheostomy in place. Any case in which total intravenous anesthesia is
used. Patient in which a mask alone is used for airway management.
• Sample Size
Using an a priori sample size calculator for multiple regression analysis based on effect
size f2 of 0.05 in a model with 7 predictors, a probablility level of 0.05, and a statistical
power of 80% we estimate a sample size of 293 patients. The calculator can be found at the
following internet address: http://www.danielsoper.com/statcalc/calculator.aspx?id=1 Given
the number of 293 patients we will observe 300 extubations.
Interventions and Interactions:
Interventions and interactions for the patient should be minimal since this is an
observational study. Study personnel will monitor the pediatric operating room schedule
during the day to look for cases where an endotracheal tube is being used for airway
management in children less than 7 years of age. Study personnel will consult with the
responsible anesthesia team and will prospectively record data at the time of emergence and
extubation. They will also intermittently observe the patient in the post anesthesia care
unit but may delegate the recording of respiratory data in the post anesthesia care unit at
arrival, 5, 10, and 30 minutes. They will also record post anesthesia care unit length of
stay.
Outcome Measure(s)
Outcome measures will be successful, moderately successful or failed extubation and the
correlation, frequency, and predictive value of individual subjective and objective criteria
for extubation.
Analytical Plan
Results will be analyzed initially using descriptive statistics and multivariate logistic
regression analysis to determine the predictive value of different criteria for successful
extubation and further to determine if one criteria is more predictive than another.
Human Subjects Protection
Subject Recruitment Methods
Study participants will be identified by looking at the pediatric operating room schedule and
consulting with the anesthesia team responsible for the patient to determine if they used an
endotracheal tube for airway management and then further if they plan to extubate the patient
at the end of the procedure. If the aforementioned is acceptable and the patient meets the
age inclusion criteria and a member of the study is available they will observe the emergence
and record data based on what is occurring during the emergence and extubation.
Informed Consent
Informed consent will not be sought as this is an observational study designed to observe
criteria used in the routine practice of pediatric anesthesia to determine the timing of
extubation. All clinical care will be administered at the discretion of the attending
anesthesiologist according to their routine standard practice.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06262360 -
Changes in Pulmonary Ventilation Distribution Assessed by Electrical Impedance Tomography in Healthy Children Under General Anesthesia
|
N/A |