Extubation in Pediatric Patients: Proactive or Passive?

Which is the Better Choice for Extubation in Pediatric Patients: Proactive or Passive?

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Cough; Tracheal Extubation
• Intervention / Treatment: Behavioral: proactive 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200031
      • Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group A; children were extubated in a light plane of anesthesia, when they are still asleep or have swallowing reflex.	Behavioral: proactive extubation; when children is breathing spontaneously and adequately in PACU,endotracheal tube was removed directly
No Intervention: group B; Tracheal extubation was performed when the patient regained consciousness, facial grimace, spontaneous eye opening, and purposeful arm movement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coughing	1 if a single cough occurred and saturation by pulse oximetry (SpO2) ≥95%; 2 if multiple coughs occurred and SpO2 ≥95%; 3 if multiple coughs occurred and SpO2 <95%; and 4 if multiple coughs occurred, SpO2 <95%, and coughing required administration of i.v . medication.	at the time of extubation within 1 minute
Respiratory complications	the number of patients who had gagging, clenched teeth, gross purposeful movements, breath holding, laryngospasm, or desaturation to SpO2<90%	During the time when patients stayed in PACU after extubation, an average of 45 min
Time to spontaneous eye opening	Time to spontaneous eye opening	The time from PACU arrival to spontaneous eye opening, an average of 45 min
Time to discharge from PACU	Time to discharge from PACU	The time from patients arrived PACU to who was decided to discharge from PACU，an average of 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	In years	6 hours before intervention
Height	In meters	6 hours before intervention
Time to extubation	The time of extubation after surgery	The time from PACU arrival to tracheal extubation, an average of 30 min
End-tidal concentration of minimum effective alveolar anesthetic concentration	In percentage	The time before patients were decided to extubate, within 1 minute
Weight	In kilograms	6 hours before intervention
Systolic blood pressure	Hemodynamic parameter	5 minutes before extubation
Systolic blood pressure	Hemodynamic parameter	1 minute after extubation
Systolic blood pressure	Hemodynamic parameter	5 minutes after extubation
Diastolic blood pressure	Hemodynamic parameter	5 minutes before extubation
Diastolic blood pressure	Hemodynamic parameter	1 minute after extubation
Diastolic blood pressure	Hemodynamic parameter	5 minutes after extubation
Heart rate	hemodynamic parameter	5 minutes before extubation
Heart rate	hemodynamic parameter	1 minute after extubation
Heart rate	hemodynamic parameter	5 minutes after extubation

Collaborators and Investigators

• Sponsor: Eye & ENT Hospital of Fudan University

Publications and helpful links

General Publications

• 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.
• Bidwai AV, Bidwai VA, Rogers CR, Stanley TH. Blood-pressure and pulse-rate responses to endotracheal extubation with and without prior injection of lidocaine. Anesthesiology. 1979 Aug;51(2):171-3. doi: 10.1097/00000542-197908000-00020. No abstract available.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2020
• Primary Completion (Actual): December 14, 2020
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: May 3, 2020
• First Submitted That Met QC Criteria: June 13, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): January 31, 2023
• Last Update Submitted That Met QC Criteria: January 28, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: extubation; respiratory complication; proactive; passive
• Other Study ID Numbers: A/P extubation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No