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

NCT ID: NCT04711174

Last Updated: 2022-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-31

Study Completion Date

2022-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Complication of Device Removal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

LMA removal

Intervention Type BEHAVIORAL

the timing when conducting 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

LMA removal

Intervention Type BEHAVIORAL

the timing when conducting 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

LMA removal

Intervention Type BEHAVIORAL

the timing when conducting 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

LMA removal

Intervention Type BEHAVIORAL

the timing when conducting LMA removal

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LMA removal

the timing when conducting LMA removal

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Aldrete score

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Maximum Eligible Age

6 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eye & ENT Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Wenxian Li

Role: PRINCIPAL_INVESTIGATOR

Eye and ENT Hospital of Fudan University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Eye and EENT hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LMA removal strategy

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.