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

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.

Study Overview

• Status: Completed
• Conditions: Complication of Device Removal
• Intervention / Treatment: Behavioral: LMA removal

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.

• Study Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 021
      • Eye and EENT hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

children

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
movement,high Aldrete score group (MH group); 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; the timing when conducting LMA removal; Other Names: Aldrete score
movement,low Aldrete score group (ML group); 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; the timing when conducting LMA removal; Other Names: Aldrete score
sedation,high Aldrete score group (SH group); 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; the timing when conducting LMA removal; Other Names: Aldrete score
sedation,low Aldrete score group (SL group); 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; the timing when conducting LMA removal; Other Names: Aldrete score

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Eye & ENT Hospital of Fudan University
• Investigators: Principal Investigator: Wenxian Li, Eye and ENT Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 31, 2020
• Primary Completion (ACTUAL): December 31, 2021
• Study Completion (ACTUAL): February 28, 2022

Study Registration Dates

• First Submitted: January 4, 2021
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (ACTUAL): January 15, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2022
• Last Update Submitted That Met QC Criteria: March 25, 2022
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: LMA removal; evaluation of transitional criteria from PACU
• Other Study ID Numbers: LMA removal strategy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No