Clinical trial NCT04711174: Optimization for Laryngeal Mask Removal Strategy and Evaluation of Transitional Criteria From PACU in Children
Official title: Optimization for Laryngeal Mask Removal Strategy and Evaluation of Transitional Criteria From PACU in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complication of Device Removal
Keywords: LMA removal
evaluation of transitional criteria from PACU
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 3
Sex: MALE
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children

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.

Eligibility criteria: 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

Primary outcomes:
measure: baseline heart rate
timeFrame: before induction
measure: heart rate after induction
timeFrame: immediately after induction
measure: heart rate in procedure
timeFrame: in procedure
measure: heart rate when transited into PACU
timeFrame: immediately after transited into PACU (first measured data in PACU)
measure: heart rate when transited out PACU
timeFrame: before transited out of PACU (last measured data in PACU)
measure: heart rate spontaneous respiratory
timeFrame: immediately after recovering spontaneous respiratory
measure: heart rate effective spontaneous respiratory
timeFrame: immediately after effective spontaneous respiratory recovers
measure: heart rate LMA removal
timeFrame: immediately after LMA removed
measure: baseline mean blood pressure
timeFrame: before induction
measure: mean blood pressure after induction
timeFrame: immediately after induction
measure: mean blood pressure in procedure
timeFrame: in procedure
measure: mean blood pressure when transited into PACU
timeFrame: immediately after transited into PACU (first measured data in PACU)
measure: mean blood pressure when transited out PACU
timeFrame: before transited out of PACU (last measured data in PACU)
measure: mean blood pressure spontaneous respiratory
timeFrame: immediately after recovering spontaneous respiratory
measure: mean blood pressure spontaneous respiratory
timeFrame: immediately after effective spontaneous respiratory recovers
measure: mean blood pressure LMA removal
timeFrame: immediately after LMA removed
measure: time length of LMA removal
timeFrame: from the time point of the child be transited into PACU until the time point of the LMA be removed
measure: dwell time length in PACU
timeFrame: from the time point of the child be transited into PACU until the time point of the child be transited out of PACU
measure: cough
timeFrame: from the time point of the LMA be removed until the time point of the child be transited out of PACU
measure: desaturation
timeFrame: from the time point of the LMA be removed until the time point of the child be transited out of PACU
measure: clenching
timeFrame: from the time point of the LMA be removed until the time point of the child be transited out of PACU
measure: gross body movement
timeFrame: from the time point of the LMA be removed until the time point of the child be transited out of PACU
measure: breath holding
timeFrame: from the time point of the LMA be removed until the time point of the child be transited out of PACU
measure: airway obstruction
timeFrame: from the time point of the LMA be removed until the time point of the child be transited out of PACU
Secondary outcomes:
measure: parents' satisfaction score
timeFrame: up to 3 days after surgery
measure: sleep quality score
timeFrame: up to 3 days after surgery
measure: FLACC(face,legs,activity,cry,consolability) scale score
timeFrame: up to 3 days after surgery
measure: anxiety score
timeFrame: up to 3 days after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eye and EENT hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Eye and ENT Hospital of Fudan University
name: Wenxian Li
role: PRINCIPAL_INVESTIGATOR
References: