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

March 25, 2022 updated by: Eye & ENT Hospital of Fudan University
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
baseline heart rate
Time Frame: before induction
heart rate before induction
before induction
heart rate after induction
Time Frame: immediately after induction
heart rate after induction
immediately after induction
heart rate in procedure
Time Frame: in procedure
heart rate in procedure
in procedure
heart rate when transited into PACU
Time Frame: immediately after transited into PACU (first measured data in PACU)
heart rate into PACU
immediately after transited into PACU (first measured data in PACU)
heart rate when transited out PACU
Time Frame: before transited out of PACU (last measured data in PACU)
heart rate out PACU
before transited out of PACU (last measured data in PACU)
heart rate spontaneous respiratory
Time Frame: immediately after recovering spontaneous respiratory
heart rate when spontaneous respiratory recovers
immediately after recovering spontaneous respiratory
heart rate effective spontaneous respiratory
Time Frame: immediately after effective spontaneous respiratory recovers
heart rate when effective spontaneous respiratory recovers
immediately after effective spontaneous respiratory recovers
heart rate LMA removal
Time Frame: immediately after LMA removed
heart rate when LMA removed
immediately after LMA removed
baseline mean blood pressure
Time Frame: before induction
mean blood pressure before induction
before induction
mean blood pressure after induction
Time Frame: immediately after induction
mean blood pressure after induction
immediately after induction
mean blood pressure in procedure
Time Frame: in procedure
mean blood pressure in procedure
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
immediately after transited into PACU (first measured data in 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
before transited out of PACU (last measured data in PACU)
mean blood pressure spontaneous respiratory
Time Frame: immediately after recovering spontaneous respiratory
mean blood pressure when spontaneous respiratory recovers
immediately after recovering spontaneous respiratory
mean blood pressure spontaneous respiratory
Time Frame: immediately after effective spontaneous respiratory recovers
mean blood pressure when effective spontaneous respiratory recovers
immediately after effective spontaneous respiratory recovers
mean blood pressure LMA removal
Time Frame: immediately after LMA removed
mean blood pressure when effective spontaneous respiratory recovers
immediately after LMA removed
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
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 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
from the time point of the child be transited into PACU until the time point of the child be transited out of 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
from the time point of the LMA be removed until the time point of the child be transited out of PACU
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
from the time point of the LMA be removed until the time point of the child be transited out of PACU
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
from the time point of the LMA be removed until the time point of the child be transited out of PACU
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
from the time point of the LMA be removed until the time point of the child be transited out of PACU
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
from the time point of the LMA be removed until the time point of the child be transited out of PACU
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
from the time point of the LMA be removed until the time point of the child be transited out of PACU

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
up to 3 days after surgery
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
up to 3 days after surgery
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
up to 3 days after surgery
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
up to 3 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eye & ENT Hospital of Fudan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wenxian Li, Eye and ENT Hospital of Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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