An observational study in Complication of Device Removal, sponsored by Eye & ENT Hospital of Fudan University. Completed at 1 site in China. Open to male participants aged Up to 6 Years. Per ClinicalTrials.gov, last updated 2022-04-05.
Sponsored by Eye & ENT Hospital of Fudan University · Observational
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.
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.
Eye & ENT Hospital of Fudan University is the lead sponsor of 121 studies on the registry; 67 are open to participants now.
Counted across the registry records on this site, refreshed daily.
children
Exclusion Criteria:
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
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
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
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
Also known as: Aldrete score
baseline heart rate
heart rate before induction
Time frame: before induction
heart rate after induction
heart rate after induction
Time frame: immediately after induction
heart rate in procedure
heart rate in procedure
Time frame: in procedure
heart rate when transited into PACU
heart rate into PACU
Time frame: immediately after transited into PACU (first measured data in PACU)
heart rate when transited out PACU
heart rate out PACU
Time frame: before transited out of PACU (last measured data in PACU)
heart rate spontaneous respiratory
heart rate when spontaneous respiratory recovers
Time frame: immediately after recovering spontaneous respiratory
heart rate effective spontaneous respiratory
heart rate when effective spontaneous respiratory recovers
Time frame: immediately after effective spontaneous respiratory recovers
heart rate LMA removal
heart rate when LMA removed
Time frame: immediately after LMA removed
baseline mean blood pressure
mean blood pressure before induction
Time frame: before induction
mean blood pressure after induction
mean blood pressure after induction
Time frame: immediately after induction
mean blood pressure in procedure
mean blood pressure in procedure
Time frame: in procedure
mean blood pressure when transited into PACU
mean blood pressure into PACU
Time frame: immediately after transited into PACU (first measured data in PACU)
mean blood pressure when transited out PACU
mean blood pressure out PACU
Time frame: before transited out of PACU (last measured data in PACU)
mean blood pressure spontaneous respiratory
mean blood pressure when spontaneous respiratory recovers
Time frame: immediately after recovering spontaneous respiratory
mean blood pressure spontaneous respiratory
mean blood pressure when effective spontaneous respiratory recovers
Time frame: immediately after effective spontaneous respiratory recovers
mean blood pressure LMA removal
mean blood pressure when effective spontaneous respiratory recovers
Time frame: immediately after LMA removed
time length of LMA removal
time length from the child transited into PACU to LMA removal
Time frame: 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
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
cough
cough count and severity
Time frame: 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
Time frame: 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
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
gross body movement during LMA removal
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
breath holding during LMA removal
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
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
parents' satisfaction score
questionnaire scored from 1-5 to assess the parents' satisfaction : score 1 for worst satisfied, score 5 for best satisfied
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: up to 3 days after surgery
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Eye & ENT Hospital of Fudan University