ClinicalTrials.Veeva

Menu

Extubation in Pediatric Patients: Proactive or Passive?

E

Eye & ENT Hospital of Fudan University

Status

Invitation-only

Conditions

Tracheal Extubation
Cough

Treatments

Behavioral: proactive extubation

Study type

Interventional

Funder types

Other

Identifiers

NCT04432701
A/P extubation

Details and patient eligibility

About

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).

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

3 to 7 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups

group A
Active Comparator group
Description:
children were extubated in a light plane of anesthesia, when they are still asleep or have swallowing reflex.
Treatment:
Behavioral: proactive extubation
group B
No Intervention group
Description:
Tracheal extubation was performed when the patient regained consciousness, facial grimace, spontaneous eye opening, and purposeful arm movement.

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems