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Extubation in Pediatric Patients: Proactive or Passive?

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04432701
Enrollment
60
Registered
2020-06-16
Start date
2020-07-10
Completion date
2024-04-30
Last updated
2023-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cough, Tracheal Extubation

Keywords

passive, proactive, extubation, respiratory complication

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.

Interventions

BEHAVIORALproactive extubation

when children is breathing spontaneously and adequately in PACU,endotracheal tube was removed directly

Sponsors

Eye & ENT Hospital of Fudan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 7 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Coughingat the time of extubation within 1 minute1 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 complicationsDuring the time when patients stayed in PACU after extubation, an average of 45 minthe number of patients who had gagging, clenched teeth, gross purposeful movements, breath holding, laryngospasm, or desaturation to SpO2\<90%
Time to spontaneous eye openingThe time from PACU arrival to spontaneous eye opening, an average of 45 minTime to spontaneous eye opening
Time to discharge from PACUThe time from patients arrived PACU to who was decided to discharge from PACU,an average of 1 hourTime to discharge from PACU

Secondary

MeasureTime frameDescription
Age6 hours before interventionIn years
Weight6 hours before interventionIn kilograms
Diastolic blood pressure5 minutes before extubationHemodynamic parameter
Systolic blood pressure5 minutes before extubationHemodynamic parameter
Height6 hours before interventionIn meters
Heart rate5 minutes before extubationhemodynamic parameter
Time to extubationThe time from PACU arrival to tracheal extubation, an average of 30 minThe time of extubation after surgery
End-tidal concentration of minimum effective alveolar anesthetic concentrationThe time before patients were decided to extubate, within 1 minuteIn percentage

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026