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Completed No phase listed Observational

Extubation in Pediatric Patients: An Observational Study

ClinicalTrials.gov ID: NCT02963532

Public ClinicalTrials.gov record NCT02963532. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 7, 2026, 7:45 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Direct Comparison of Predictors for Extubation in Children Less Than 7 Years Old Undergoing Anesthesia: A Prospective Observational Study

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02963532
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Enrollment
600 participants

Conditions and interventions

Eligibility (public fields only)

Age range
1 Month to 7 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 30, 2016
Primary completion
Dec 3, 2017
Completion
Dec 3, 2017
Last update posted
Jan 7, 2018

2016 – 2017

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Wake Forest University Health Sciences Winston-Salem North Carolina 27157

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02963532, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 7, 2018 · Synced Sep 7, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02963532 live on ClinicalTrials.gov.

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