Extubation in Pediatric Patients: Proactive or Passive?

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cough, Tracheal Extubation

Intervention / Treatment
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* Behavioral: proactive extubation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 | 
| Age | In years | 6 hours before intervention | 
| Weight | In kilograms | 6 hours before intervention | 
| Height | In meters | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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passive, proactive, extubation, respiratory complication