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Complication of Device RemovalNCT04711174

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

An observational study of Complication of Device Removal, run by Eye & ENT Hospital of Fudan University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 6 years, men only
Conditions the study is for
Complication of Device Removal
What is being tested?
LMA removal
How many people
3 participants
Where
1 siteChina
Study dates
31 Jul 2020to 28 Feb 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 6 years
  • Men only
  • No healthy volunteers
  • Child

Study population: children

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Eye and EENT hospital of Fudan University

    Shanghai, Shanghai Municipality, 021

Other trials in China

About this study

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.

Read the 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.

Being tested
LMA removal
Keywords
LMA removal, evaluation of transitional criteria from PACU

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LMA removalBehavioural

    Also called Aldrete score

    the timing when conducting LMA removal

Study groups in NCT04711174
Study groupRoleWhat they receive
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
Receives: 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
Receives: 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
Receives: 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
Receives: Behavioral: LMA removal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. baseline heart rate

    heart rate before induction

    Measured: before induction

  2. heart rate after induction

    heart rate after induction

    Measured: immediately after induction

  3. heart rate in procedure

    heart rate in procedure

    Measured: in procedure

  4. heart rate when transited into PACU

    heart rate into PACU

    Measured: immediately after transited into PACU (first measured data in PACU)

  5. heart rate when transited out PACU

    heart rate out PACU

    Measured: before transited out of PACU (last measured data in PACU)

  6. heart rate spontaneous respiratory

    heart rate when spontaneous respiratory recovers

    Measured: immediately after recovering spontaneous respiratory

  7. heart rate effective spontaneous respiratory

    heart rate when effective spontaneous respiratory recovers

    Measured: immediately after effective spontaneous respiratory recovers

  8. heart rate LMA removal

    heart rate when LMA removed

    Measured: immediately after LMA removed

  9. baseline mean blood pressure

    mean blood pressure before induction

    Measured: before induction

  10. mean blood pressure after induction

    mean blood pressure after induction

    Measured: immediately after induction

  11. mean blood pressure in procedure

    mean blood pressure in procedure

    Measured: in procedure

  12. mean blood pressure when transited into PACU

    mean blood pressure into PACU

    Measured: immediately after transited into PACU (first measured data in PACU)

  13. mean blood pressure when transited out PACU

    mean blood pressure out PACU

    Measured: before transited out of PACU (last measured data in PACU)

  14. mean blood pressure spontaneous respiratory

    mean blood pressure when spontaneous respiratory recovers

    Measured: immediately after recovering spontaneous respiratory

  15. mean blood pressure spontaneous respiratory

    mean blood pressure when effective spontaneous respiratory recovers

    Measured: immediately after effective spontaneous respiratory recovers

  16. mean blood pressure LMA removal

    mean blood pressure when effective spontaneous respiratory recovers

    Measured: immediately after LMA removed

  17. time length of LMA removal

    time length from the child transited into PACU to LMA removal

    Measured: from the time point of the child be transited into PACU until the time point of the LMA be removed

  18. dwell time length in PACU

    time length of the child staying in PACU

    Measured: from the time point of the child be transited into PACU until the time point of the child be transited out of PACU

  19. cough

    cough count and severity

    Measured: from the time point of the LMA be removed until the time point of the child be transited out of PACU

  20. desaturation

    desaturation count and severity

    Measured: from the time point of the LMA be removed until the time point of the child be transited out of PACU

  21. clenching

    clenching during LMA removal

    Measured: from the time point of the LMA be removed until the time point of the child be transited out of PACU

  22. gross body movement

    gross body movement during LMA removal

    Measured: from the time point of the LMA be removed until the time point of the child be transited out of PACU

  23. breath holding

    breath holding during LMA removal

    Measured: from the time point of the LMA be removed until the time point of the child be transited out of PACU

  24. airway obstruction

    airway obstruction

    Measured: from the time point of the LMA be removed until the time point of the child be transited out of PACU

Secondary outcomes (4)

  1. parents' satisfaction score

    questionnaire scored from 1-5 to assess the parents' satisfaction : score 1 for worst satisfied, score 5 for best satisfied

    Measured: up to 3 days after surgery

  2. 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

    Measured: up to 3 days after surgery

  3. 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

    Measured: up to 3 days after surgery

  4. anxiety score

    questionnaire scored from 1-5 to assess the parents' anxiety : score 1 for no anxiety, score 5 for worst anxiety

    Measured: up to 3 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2021
  2. Study start31 Jul 2020
  3. Primary completion31 Dec 2021
  4. Study completion28 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04711174
Sponsor's protocol ID
LMA removal strategy
Status last verified
Apr 2021
First submitted
4 Jan 2021
Last updated
5 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Tan F, Lu W, Li S, Chen J. Discharge Under Sedated Status can Decrease Postoperative Emergence Agitation in Pediatric Patients Undergoing Strabismus Surgery: A Prospective Randomized Controlled Trial. J Perianesth Nurs. 2024 Dec;39(6):985-989. doi: 10.1016/j.jopan.2024.01.014. Epub 2024 Jun 4.

    PubMed 38842951

Questions about this trial

What is this clinical trial studying?

An observational study of Complication of Device Removal, run by Eye & ENT Hospital of Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

baseline heart rate (time frame: before induction). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04711174, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.

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