Extubation in Pediatric Patients: Proactive or Passive?

January 28, 2023 updated by: Eye & ENT Hospital of Fudan University

Which is the Better Choice for Extubation in Pediatric Patients: Proactive or Passive?

Smooth extubation process can reduce the complications in recovery time. This study aimed to investigate what is the better time to extubation when children is breathing spontaneously and adequately: waiting until children have movements or wakefulness (passive extubation）or removing endotracheal tube directly (proactive tracheal extubation).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

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

This is a randomized, controlled cross-over trial. The hypothesis of this study is that the different extubation protocol can impact recovery quality in children in post-anaesthesia care unit (PACU). Patients aged 3-7 years were randomized into two equal groups: proactive extubation (Group A) and passive extubation. At the end of surgery, sevoflurane was turned off and patients all delivered into PACU for recovery. Patient was positioned on his or her lateral side. The ventilation was switched to positive airway pressure (CPAP) mode once the patients regained spontaneous respiration. After spontaneous breathing turn to regular and sufficient（tidal volume >6-8 ml/kg, respiratory rate >10 times per minutes , end tidal carbon dioxide concentration >7.19 mmHg）, the trachea tube could be removed. In Group A, patients were extubated in a light plane of anesthesia, when they are still asleep or have swallowing reflex. In Group B, tracheal extubation was performed when the patient regained consciousness, facial grimace, spontaneous eye opening, and purposeful arm movement. After extubation, 2 L/min oxygen was administered with Venturi face mask for 10 min in both groups. Patients were transported to the ward until they breathed air with a patent airway. The extubation time, recovery characteristics and respiratory complication were recorded.

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.
Interventional

Enrollment (Anticipated)

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.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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, 200031
        • Anesthesiology Department of Affiliated Eye and ENT Hospital, 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

3 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • American Society of Anesthesiologists physical status aged 3-7 years

Exclusion Criteria:

  • a suspected difficult airway reactive airway disease, recent upper respiratory tract infection gastrointestinal reflux obesity (body mass index>30 kg/m2

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Active Comparator: group A
children were extubated in a light plane of anesthesia, when they are still asleep or have swallowing reflex.
Behavioral: proactive extubation
when children is breathing spontaneously and adequately in PACU,endotracheal tube was removed directly
No Intervention: group B
Tracheal extubation was performed when the patient regained consciousness, facial grimace, spontaneous eye opening, and purposeful arm movement.

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
Coughing
Time Frame: at the time of extubation within 1 minute
1 if a single cough occurred and saturation by pulse oximetry (SpO2) ≥95%; 2 if multiple coughs occurred and SpO2 ≥95%; 3 if multiple coughs occurred and SpO2 <95%; and 4 if multiple coughs occurred, SpO2 <95%, and coughing required administration of i.v . medication.
at the time of extubation within 1 minute
Respiratory complications
Time Frame: During the time when patients stayed in PACU after extubation, an average of 45 min
the number of patients who had gagging, clenched teeth, gross purposeful movements, breath holding, laryngospasm, or desaturation to SpO2<90%
During the time when patients stayed in PACU after extubation, an average of 45 min
Time to spontaneous eye opening
Time Frame: The time from PACU arrival to spontaneous eye opening, an average of 45 min
Time to spontaneous eye opening
The time from PACU arrival to spontaneous eye opening, an average of 45 min
Time to discharge from PACU
Time Frame: The time from patients arrived PACU to who was decided to discharge from PACU，an average of 1 hour
Time to discharge from PACU
The time from patients arrived PACU to who was decided to discharge from PACU，an average of 1 hour

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
Age
Time Frame: 6 hours before intervention
In years
6 hours before intervention
Height
Time Frame: 6 hours before intervention
In meters
6 hours before intervention
Time to extubation
Time Frame: The time from PACU arrival to tracheal extubation, an average of 30 min
The time of extubation after surgery
The time from PACU arrival to tracheal extubation, an average of 30 min
End-tidal concentration of minimum effective alveolar anesthetic concentration
Time Frame: The time before patients were decided to extubate, within 1 minute
In percentage
The time before patients were decided to extubate, within 1 minute
Weight
Time Frame: 6 hours before intervention
In kilograms
6 hours before intervention
Systolic blood pressure
Time Frame: 5 minutes before extubation
Hemodynamic parameter
5 minutes before extubation
Systolic blood pressure
Time Frame: 1 minute after extubation
Hemodynamic parameter
1 minute after extubation
Systolic blood pressure
Time Frame: 5 minutes after extubation
Hemodynamic parameter
5 minutes after extubation
Diastolic blood pressure
Time Frame: 5 minutes before extubation
Hemodynamic parameter
5 minutes before extubation
Diastolic blood pressure
Time Frame: 1 minute after extubation
Hemodynamic parameter
1 minute after extubation
Diastolic blood pressure
Time Frame: 5 minutes after extubation
Hemodynamic parameter
5 minutes after extubation
Heart rate
Time Frame: 5 minutes before extubation
hemodynamic parameter
5 minutes before extubation
Heart rate
Time Frame: 1 minute after extubation
hemodynamic parameter
1 minute after extubation
Heart rate
Time Frame: 5 minutes after extubation
hemodynamic parameter
5 minutes after extubation

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 10, 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 14, 2020

Study Completion (Anticipated)

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.
April 1, 2024

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).
May 3, 2020

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.
June 13, 2020

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.
June 16, 2020

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.
January 31, 2023

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.
January 28, 2023

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.
January 1, 2023

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.
  • A/P extubation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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