Extubation in Pediatric Patients: Proactive or Passive?

Not Applicable

• Conditions: Cough; Tracheal Extubation
• Interventions: Behavioral: proactive extubation

• Registration Number: NCT04432701
• Lead Sponsor: Eye & ENT Hospital of Fudan University

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.

Study Timeline

• Study First Submitted: 2020-05-03
• Study First Submitted QC: 2020-06-13
• Study First Posted: 2020-06-16
• Study Start: 2020-07-10
• Primary Completion: 2020-12-14
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-28
• Last Update Posted: 2023-01-31
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A	proactive extubation	children were extubated in a light plane of anesthesia, when they are still asleep or have swallowing reflex.

Primary Outcome Measures

Name	Time	Method
Time to discharge from PACU	The time from patients arrived PACU to who was decided to discharge from PACU，an average of 1 hour	Time to discharge from PACU
Time to spontaneous eye opening	The time from PACU arrival to spontaneous eye opening, an average of 45 min	Time to spontaneous eye opening
Coughing	at the time of extubation within 1 minute	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.
Respiratory complications	During the time when patients stayed in PACU after extubation, an average of 45 min	the number of patients who had gagging, clenched teeth, gross purposeful movements, breath holding, laryngospasm, or desaturation to SpO2\<90%

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China