Extubation in Pediatric Patients: An Observational Study

NCT02963532 | Completed

• 1 other identifier: 00039203
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Anesthesia, Pediatric

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

We are observing criteria present at extubation OTHER

We will not be performing any intervention. We will only be observing what clinical data is present at the time of extubation and how predictive are different pieces of clinical data.

Eligibility Criteria

• Age: 1 Month - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Pediatric Patients \< 7 years of age.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Study Officials

• Thomas Templeton, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2016
• First Posted: November 15, 2016
• Study Start: December 1, 2016
• Primary Completion: December 4, 2017
• Study Completion: December 4, 2017
• Last Updated: January 8, 2018

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)