Clinical trial NCT04432701: Extubation in Pediatric Patients: Proactive or Passive?
Official title: Which is the Better Choice for Extubation in Pediatric Patients: Proactive or Passive?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cough
Tracheal Extubation
Keywords: passive
proactive
extubation
respiratory complication
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Smooth extubation process can reduce the complications in recovery time. This study aimed to investigate what is the better time to extubation when children is breathing spontaneously and adequately: waiting until children have movements or wakefulness (passive extubation）or removing endotracheal tube directly (proactive tracheal extubation).

Detailed description: This is a randomized, controlled cross-over trial. The hypothesis of this study is that the different extubation protocol can impact recovery quality in children in post-anaesthesia care unit (PACU). Patients aged 3-7 years were randomized into two equal groups: proactive extubation (Group A) and passive extubation. At the end of surgery, sevoflurane was turned off and patients all delivered into PACU for recovery. Patient was positioned on his or her lateral side. The ventilation was switched to positive airway pressure (CPAP) mode once the patients regained spontaneous respiration. After spontaneous breathing turn to regular and sufficient（tidal volume \>6-8 ml/kg, respiratory rate \>10 times per minutes , end tidal carbon dioxide concentration \>7.19 mmHg）, the trachea tube could be removed. In Group A, patients were extubated in a light plane of anesthesia, when they are still asleep or have swallowing reflex. In Group B, tracheal extubation was performed when the patient regained consciousness, facial grimace, spontaneous eye opening, and purposeful arm movement. After extubation, 2 L/min oxygen was administered with Venturi face mask for 10 min in both groups. Patients were transported to the ward until they breathed air with a patent airway. The extubation time, recovery characteristics and respiratory complication were recorded.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status aged 3-7 years

Exclusion Criteria:

* a suspected difficult airway reactive airway disease, recent upper respiratory tract infection gastrointestinal reflux obesity (body mass index\>30 kg/m2

Primary outcomes:
measure: Coughing
timeFrame: at the time of extubation within 1 minute
measure: Respiratory complications
timeFrame: During the time when patients stayed in PACU after extubation, an average of 45 min
measure: Time to spontaneous eye opening
timeFrame: The time from PACU arrival to spontaneous eye opening, an average of 45 min
measure: Time to discharge from PACU
timeFrame: The time from patients arrived PACU to who was decided to discharge from PACU，an average of 1 hour
Secondary outcomes:
measure: Time to extubation
timeFrame: The time from PACU arrival to tracheal extubation, an average of 30 min
measure: End-tidal concentration of minimum effective alveolar anesthetic concentration
timeFrame: The time before patients were decided to extubate, within 1 minute
measure: Age
timeFrame: 6 hours before intervention
measure: Weight
timeFrame: 6 hours before intervention
measure: Height
timeFrame: 6 hours before intervention
measure: Systolic blood pressure
timeFrame: 5 minutes before extubation
measure: Systolic blood pressure
timeFrame: 1 minute after extubation
measure: Systolic blood pressure
timeFrame: 5 minutes after extubation
measure: Diastolic blood pressure
timeFrame: 5 minutes before extubation
measure: Diastolic blood pressure
timeFrame: 1 minute after extubation
measure: Diastolic blood pressure
timeFrame: 5 minutes after extubation
measure: Heart rate
timeFrame: 5 minutes before extubation
measure: Heart rate
timeFrame: 1 minute after extubation
measure: Heart rate
timeFrame: 5 minutes after extubation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University
state: Shanghai
Study officials:
References:
citation: Tsukamoto M, Hitosugi T, Yokoyama T. Comparison of recovery in pediatric patients: a retrospective study. Clin Oral Investig. 2019 Sep;23(9):3653-3656. doi: 10.1007/s00784-019-02993-y. Epub 2019 Jul 4.
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citation: Valley RD, Freid EB, Bailey AG, Kopp VJ, Georges LS, Fletcher J, Keifer A. Tracheal extubation of deeply anesthetized pediatric patients: a comparison of desflurane and sevoflurane. Anesth Analg. 2003 May;96(5):1320-1324. doi: 10.1213/01.ANE.0000058844.77403.16.
citation: Gonzalez RM, Bjerke RJ, Drobycki T, Stapelfeldt WH, Green JM, Janowitz MJ, Clark M. Prevention of endotracheal tube-induced coughing during emergence from general anesthesia. Anesth Analg. 1994 Oct;79(4):792-5. doi: 10.1213/00000539-199410000-00030. No abstract available.
citation: Fan Q, Hu C, Ye M, Shen X. Dexmedetomidine for tracheal extubation in deeply anesthetized adult patients after otologic surgery: a comparison with remifentanil. BMC Anesthesiol. 2015 Jul 23;15:106. doi: 10.1186/s12871-015-0088-7.
citation: Inomata S, Yaguchi Y, Taguchi M, Toyooka H. End-tidal sevoflurane concentration for tracheal extubation (MACEX) in adults: comparison with isoflurane. Br J Anaesth. 1999 Jun;82(6):852-6. doi: 10.1093/bja/82.6.852.