Complication of Device Removal
Conditions
Keywords
LMA removal, evaluation of transitional criteria from PACU
Brief summary
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
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.
Interventions
BEHAVIORALLMA removal
the timing when conducting LMA removal
Sponsors
Eye & ENT Hospital of Fudan University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
No minimum to 6 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| airway obstruction | from the time point of the LMA be removed until the time point of the child be transited out of PACU | airway obstruction |
| desaturation | from the time point of the LMA be removed until the time point of the child be transited out of PACU | desaturation count and severity |
| clenching | from the time point of the LMA be removed until the time point of the child be transited out of PACU | clenching during LMA removal |
| gross body movement | from the time point of the LMA be removed until the time point of the child be transited out of PACU | gross body movement during LMA removal |
| breath holding | from the time point of the LMA be removed until the time point of the child be transited out of PACU | breath holding during LMA removal |
| baseline heart rate | before induction | heart rate before induction |
| heart rate after induction | immediately after induction | heart rate after induction |
| heart rate in procedure | in procedure | heart rate in procedure |
| heart rate when transited into PACU | immediately after transited into PACU (first measured data in PACU) | heart rate into PACU |
| heart rate when transited out PACU | before transited out of PACU (last measured data in PACU) | heart rate out PACU |
| heart rate spontaneous respiratory | immediately after recovering spontaneous respiratory | heart rate when spontaneous respiratory recovers |
| heart rate effective spontaneous respiratory | immediately after effective spontaneous respiratory recovers | heart rate when effective spontaneous respiratory recovers |
| heart rate LMA removal | immediately after LMA removed | heart rate when LMA removed |
| baseline mean blood pressure | before induction | mean blood pressure before induction |
| mean blood pressure after induction | immediately after induction | mean blood pressure after induction |
| mean blood pressure in procedure | in procedure | mean blood pressure in procedure |
| mean blood pressure when transited into PACU | immediately after transited into PACU (first measured data in PACU) | mean blood pressure into PACU |
| mean blood pressure when transited out PACU | before transited out of PACU (last measured data in PACU) | mean blood pressure out PACU |
| mean blood pressure spontaneous respiratory | immediately after recovering spontaneous respiratory | mean blood pressure when spontaneous respiratory recovers |
| mean blood pressure LMA removal | immediately after LMA removed | mean blood pressure when effective spontaneous respiratory recovers |
| time length of LMA removal | from the time point of the child be transited into PACU until the time point of the LMA be removed | time length from the child transited into PACU to LMA removal |
| dwell time length 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 | time length of the child staying in PACU |
| cough | from the time point of the LMA be removed until the time point of the child be transited out of PACU | cough count and severity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| sleep quality score | up to 3 days after surgery | questionnaire scored from 1-5 to assess the children's sleep quality : score 1 for worst sleep quality, score 5 for best sleep quality |
| FLACC(face,legs,activity,cry,consolability) scale score | up to 3 days after surgery | FLACC scale scored from 0-10 to assess the children's pain after surgery: score 0 for no pain, score 10 for worst pain |
| anxiety score | up to 3 days after surgery | questionnaire scored from 1-5 to assess the parents' anxiety : score 1 for no anxiety, score 5 for worst anxiety |
| parents' satisfaction score | up to 3 days after surgery | questionnaire scored from 1-5 to assess the parents' satisfaction : score 1 for worst satisfied, score 5 for best satisfied |
Countries
China
Outcome results
None listed