Eye and EENT hospital of Fudan University
Shanghai, Shanghai Municipality, 021, China
Completed
NCT Number: NCT04711174
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.
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Conditions
Age range
Up to 6 year
Sex eligibility
Male
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
LMA removal
Behavioralthe timing when conducting LMA removal
Other names: Aldrete score
Primary outcomes
-
baseline heart rate
Time frame: before induction
heart rate before induction
-
heart rate after induction
Time frame: immediately after induction
heart rate after induction
-
heart rate in procedure
Time frame: in procedure
heart rate in procedure
-
heart rate when transited into PACU
Time frame: immediately after transited into PACU (first measured data in PACU)
heart rate into PACU
-
heart rate when transited out PACU
Time frame: before transited out of PACU (last measured data in PACU)
heart rate out PACU
-
heart rate spontaneous respiratory
Time frame: immediately after recovering spontaneous respiratory
heart rate when spontaneous respiratory recovers
-
heart rate effective spontaneous respiratory
Time frame: immediately after effective spontaneous respiratory recovers
heart rate when effective spontaneous respiratory recovers
-
heart rate LMA removal
Time frame: immediately after LMA removed
heart rate when LMA removed
-
baseline mean blood pressure
Time frame: before induction
mean blood pressure before induction
-
mean blood pressure after induction
Time frame: immediately after induction
mean blood pressure after induction
-
mean blood pressure in procedure
Time frame: in procedure
mean blood pressure in procedure
-
mean blood pressure when transited into PACU
Time frame: immediately after transited into PACU (first measured data in PACU)
mean blood pressure into PACU
-
mean blood pressure when transited out PACU
Time frame: before transited out of PACU (last measured data in PACU)
mean blood pressure out PACU
-
mean blood pressure spontaneous respiratory
Time frame: immediately after recovering spontaneous respiratory
mean blood pressure when spontaneous respiratory recovers
-
mean blood pressure spontaneous respiratory
Time frame: immediately after effective spontaneous respiratory recovers
mean blood pressure when effective spontaneous respiratory recovers
-
mean blood pressure LMA removal
Time frame: immediately after LMA removed
mean blood pressure when effective spontaneous respiratory recovers
-
time length of LMA removal
Time frame: 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
Time frame: 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
Time frame: 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
-
desaturation
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: from the time point of the LMA be removed until the time point of the child be transited out of PACU
airway obstruction
Secondary outcomes
-
parents' satisfaction score
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Sponsors and collaborators
Lead sponsor
Eye & ENT Hospital of Fudan University
Other
Registry information
Important dates
- Study start
- 2020
- Primary completion
- 2021
- Study completion
- 2022
- First posted
- Jan 15, 2021
- Registry last updated
- Apr 5, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.