Optimization for Laryngeal Mask Removal Strategy and Evaluation of Transitional Criteria From PACU in Children
- Conditions
- Complication of Device Removal
- Interventions
- Behavioral: LMA removal
- Registration Number
- NCT04711174
- Lead Sponsor
- Eye & ENT Hospital of Fudan University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 3
- Children aged under 6 years old undergoing selected eye surgery
- Scheduled for general anesthesia
- With systemic disease
- Respiratory system deformity
- Respiratory infection in 4 weeks
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description movement,low Aldrete score group (ML group) LMA removal 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 movement,high Aldrete score group (MH group) LMA removal 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 sedation,low Aldrete score group (SL group) LMA removal 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 sedation,high Aldrete score group (SH group) LMA removal 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
- Primary Outcome Measures
Name Time Method 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
heart rate LMA removal immediately after LMA removed heart rate when LMA removed
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
baseline mean blood pressure before induction mean blood pressure before induction
mean blood pressure after induction immediately after induction mean blood pressure after induction
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 effective spontaneous respiratory immediately after effective spontaneous respiratory recovers heart rate when effective spontaneous respiratory recovers
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 effective spontaneous respiratory recovers mean blood pressure when effective 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
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
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
- Secondary Outcome Measures
Name Time Method 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
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
Trial Locations
- Locations (1)
Eye and EENT hospital of Fudan University
🇨🇳Shanghai, Shanghai, China