NCT04711174

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 31, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

April 5, 2022

Status Verified

April 1, 2021

Enrollment Period

1.4 years

First QC Date

January 4, 2021

Last Update Submit

March 25, 2022

Conditions

Complication of Device Removal

Keywords

LMA removalevaluation of transitional criteria from PACU

Outcome Measures

Primary Outcomes (24)

  • 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 Outcomes (4)

  • parents' satisfaction score

    up to 3 days after surgery

  • sleep quality score

    up to 3 days after surgery

  • FLACC(face,legs,activity,cry,consolability) scale score

    up to 3 days after surgery

  • anxiety score

    up to 3 days after surgery

Study Arms (4)

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

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

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

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

Interventions

LMA removalBEHAVIORAL

the timing when conducting LMA removal

Also known as: Aldrete score
movement,high Aldrete score group (MH group)movement,low Aldrete score group (ML group)sedation,high Aldrete score group (SH group)sedation,low Aldrete score group (SL group)

Eligibility Criteria

AgeUp to 6 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

children

You may qualify if:

  • Children aged under 6 years old undergoing selected eye surgery
  • Scheduled for general anesthesia

You may not qualify if:

  • With systemic disease
  • Respiratory system deformity
  • Respiratory infection in 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye and EENT hospital of Fudan University

Shanghai, Shanghai Municipality, 021, China

Location

Study Officials

  • Wenxian Li

    Eye and ENT Hospital of Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2021

First Posted

January 15, 2021

Study Start

July 31, 2020

Primary Completion

December 31, 2021

Study Completion

February 28, 2022

Last Updated

April 5, 2022

Record last verified: 2021-04

Locations

CN(1)