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NCT02963532 · ClinicalTrials.gov registry record
Extubation in Pediatric Patients: An Observational Study
A clinical trial, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- 600
- Enrollment target
NCT02963532: Completed study, sponsored by Wake Forest University Health Sciences.
NCT02963532 is a clinical trial that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 600 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02963532 has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- 600 participants
- Enrollment target
Study Summary
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
Primary Outcome
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.
Interventions
- OTHER We are observing criteria present at extubation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2016-12 |
| Est. Completion | 2017-12-04 |
What the finished NCT02963532 record still lists
NCT02963532 is an observational study that tracks outcomes without assigning an intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which We are observing criteria present at extubation is the first listed.
NCT02963532 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02963532 about?
NCT02963532 is a clinical study titled "Extubation in Pediatric Patients: An 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 extu...
What is the current status of trial NCT02963532?
This trial is currently completed. The enrollment target is 600 participants. The study started on 2016-12. Estimated completion is 2017-12-04.
What interventions are being tested in trial NCT02963532?
The interventions under investigation include: We are observing criteria present at extubation (OTHER).
Who is sponsoring clinical trial NCT02963532?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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