Optimization for Laryngeal Mask Removal Strategy and Evaluation of Transitional Criteria From PACU in Children

Study Overview
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Brief Summary
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Laryngeal mask airway(LMA) is now a widely accepted airway device in general anesthesia for children. LMA removal after operation is always practiced in post-anesthesia-care-unit(PACU). The removal timing depends on recovery of spontaneous respiration and wash-out of inhalation anesthetics. This study focuses on the optimization for LMA removal strategy. Moreover, this study also discusses the transitional criteria from PACU to the ward.

Detailed Description
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The study recruits 180 children aged under 6-year-old undergoing elective general anesthesia. Laryngeal mask is used in procedure. The children are carried into PACU to get monitored and removal the LMA. The children are randomized into 4 groups.

Official Title
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Optimization for Laryngeal Mask Removal Strategy and Evaluation of Transitional Criteria From PACU in Children

Conditions
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Complication of Device Removal

Intervention / Treatment
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* Behavioral: LMA removal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged under 6 years old undergoing selected eye surgery Scheduled for general anesthesia Exclusion Criteria: With systemic disease Respiratory system deformity Respiratory infection in 4 weeks

Ages Eligible for Study
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Maximum Age: 6 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| movement,high Aldrete score group (MH group)<br>LMA removal be conducted when the child's spontaneous respiratory recovers with body movement spontaneously, and the child be transited from PACU when Aldrete score reaches 9 | Behavioral: LMA removal<br>* the timing when conducting LMA removal<br>* Other names: Aldrete score;|
| movement,low Aldrete score group (ML group)<br>LMA removal be conducted when the child's spontaneous respiratory recovers with body movement spontaneously, and the child be transited from PACU when Aldrete score reaches 7 | Behavioral: LMA removal<br>* the timing when conducting LMA removal<br>* Other names: Aldrete score;|
| sedation,high Aldrete score group (SH group)<br>LMA removal be conducted when the child's spontaneous respiratory recovers but with no body movement, and the child be transited from PACU when Aldrete score reaches 9 | Behavioral: LMA removal<br>* the timing when conducting LMA removal<br>* Other names: Aldrete score;|
| sedation,low Aldrete score group (SL group)<br>LMA removal be conducted when the child's spontaneous respiratory recovers but with no body movement, and the child be transited from PACU when Aldrete score reaches 7 | Behavioral: LMA removal<br>* the timing when conducting LMA removal<br>* Other names: Aldrete score;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| baseline heart rate | heart rate before induction | before induction | 
| heart rate after induction | heart rate after induction | immediately after induction | 
| heart rate in procedure | heart rate in procedure | in procedure | 
| heart rate when transited into PACU | heart rate into PACU | immediately after transited into PACU (first measured data in PACU) | 
| heart rate when transited out PACU | heart rate out PACU | before transited out of PACU (last measured data in PACU) | 
| heart rate spontaneous respiratory | heart rate when spontaneous respiratory recovers | immediately after recovering spontaneous respiratory | 
| heart rate effective spontaneous respiratory | heart rate when effective spontaneous respiratory recovers | immediately after effective spontaneous respiratory recovers | 
| heart rate LMA removal | heart rate when LMA removed | immediately after LMA removed | 
| baseline mean blood pressure | mean blood pressure before induction | before induction | 
| mean blood pressure after induction | mean blood pressure after induction | immediately after induction | 
| mean blood pressure in procedure | mean blood pressure in procedure | in procedure | 
| mean blood pressure when transited into PACU | mean blood pressure into PACU | immediately after transited into PACU (first measured data in PACU) | 
| mean blood pressure when transited out PACU | mean blood pressure out PACU | before transited out of PACU (last measured data in PACU) | 
| mean blood pressure spontaneous respiratory | mean blood pressure when spontaneous respiratory recovers | immediately after recovering spontaneous respiratory | 
| mean blood pressure spontaneous respiratory | mean blood pressure when effective spontaneous respiratory recovers | immediately after effective spontaneous respiratory recovers | 
| mean blood pressure LMA removal | mean blood pressure when effective spontaneous respiratory recovers | immediately after LMA removed | 
| time length of LMA removal | time length from the child transited into PACU to LMA removal | from the time point of the child be transited into PACU until the time point of the LMA be removed | 
| dwell time length in PACU | time length of the child staying in PACU | from the time point of the child be transited into PACU until the time point of the child be transited out of PACU | 
| cough | cough count and severity | from the time point of the LMA be removed until the time point of the child be transited out of PACU | 
| desaturation | desaturation count and severity | from the time point of the LMA be removed until the time point of the child be transited out of PACU | 
| clenching | clenching during LMA removal | from the time point of the LMA be removed until the time point of the child be transited out of PACU | 
| gross body movement | gross body movement during LMA removal | from the time point of the LMA be removed until the time point of the child be transited out of PACU | 
| breath holding | breath holding during LMA removal | from the time point of the LMA be removed until the time point of the child be transited out of PACU | 
| airway obstruction | airway obstruction | from the time point of the LMA be removed until the time point of the child be transited out of PACU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| parents' satisfaction score | questionnaire scored from 1-5 to assess the parents' satisfaction : score 1 for worst satisfied, score 5 for best satisfied | up to 3 days after surgery | 
| sleep quality score | questionnaire scored from 1-5 to assess the children's sleep quality : score 1 for worst sleep quality, score 5 for best sleep quality | up to 3 days after surgery | 
| FLACC(face,legs,activity,cry,consolability) scale score | FLACC scale scored from 0-10 to assess the children's pain after surgery: score 0 for no pain, score 10 for worst pain | up to 3 days after surgery | 
| anxiety score | questionnaire scored from 1-5 to assess the parents' anxiety : score 1 for no anxiety, score 5 for worst anxiety | up to 3 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LMA removal, evaluation of transitional criteria from PACU