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
Verified date | January 2017 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 600 |
Est. completion date | December 4, 2017 |
Est. primary completion date | December 4, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Month to 7 Years |
Eligibility |
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 an LMA 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. |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quality of Extubation. Defined as: Successful, Moderately Successful, or Failed. | Successful is defined as oxygen saturation >92% and requires continuous positive airway pressure with 100% oxygen < 1 minute. Moderately successful:continuous positive airway pressure for >1 minute with 100% oxygen, inspiratory stridor without sequelae, oxygen saturation <92% for > than 30 seconds, failed: patient required reintubation, laryngospasm, breath holding > 10 seconds, requires continuous positive airway pressure > 2 minutes with 100% oxygen. | This will be observed at the time of extubation. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06262360 -
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N/A |