NCT05273294

Brief Summary

This study with children under 1 age of elective surgery as the research subjects, according to the cross diameter, compared with the traditional method of empirical catheter model, analyze the success rate, completion time of intubation, endotracheal intubation attempts and complications, explore the clinical value of pediatric endotracheal technology, to provide new ideas and methods for clinical practice.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 10, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

March 10, 2022

Status Verified

March 1, 2022

Enrollment Period

4 months

First QC Date

February 28, 2022

Last Update Submit

March 9, 2022

Conditions

Ultrasound Therapy; ComplicationsTransverse Diameter of Cricoid CartilageEndotracheal IntubationChildren

Outcome Measures

Primary Outcomes (2)

  • Success rate of endotracheal intubation

    The single success rate of endotracheal intubation between the two groups

    24 hours after surgery

  • The during time of tracheal intubation

    Time required for endotracheal intubation

    24 hours after surgery

Secondary Outcomes (1)

  • Complications of endotracheal intubation

    24 hours after surgery

Study Arms (2)

Ultrasound group

EXPERIMENTAL

Anesthesiologist will convenient color ultrasound high frequency 12MHZ array probe perpendicular to the neck, by the glottal down, until the thyroid isthmus, and ring cartilage level, ring cartilage level diameter by ultrasound, to avoid the effect of inspiration and breath on airway diameter, measurement timing should choose after anesthesia induction, mask pressure gas 1min, suspended pressure ventilation for 5s, ultrasonic measurement time is not more than 10s.Repeated measurements were averaged three times, and the maximum outer diameter of the catheter was selected, that is, the maximum outer diameter was selected closest to the measured value.

Device: Portable color Doppler ultrasound system

Control group

NO INTERVENTION

tracheal catheter models are usually selected through traditional experience, according to the age formula in Clinical Anesthesiology, People's Health Press (i. e., 2.5 for preterm infants, 3.5 at 1-6 months, 4.0 at 6-12 months).

Interventions

Portable color Doppler ultrasound systemDEVICE

In the ultrasound group, the catheter type was selected according to the results of ultrasonic measurement of transverse diameter of cricoid cartilage after induction of general anesthesia, and tracheal intubation was performed with ordinary laryngoscope after measurement

Ultrasound group

Eligibility Criteria

Age1 Month - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children under 1 year old who received selective general anesthesia for endotracheal intubation in Shengjing Hospital affiliated to China Medical University.

You may not qualify if:

  • Previous history of difficult intubation, or a history of anesthesia-related adverse events.
  • There are respiratory anatomical abnormalities, such as cleft lip and palate, throat stenosis, etc
  • There are temporomandibular joint lesions, maxillofacial scar contracture, small jaw, etc.
  • Limited head and neck activity, such as neck scar contracture, excessive obese neck shortening, cervical trauma or lesion, cervical huge tumor, congenital torticollis, etc.
  • There are acute and chronic respiratory diseases, such as respiratory tract infection and bronchial asthma.
  • There are diseases affecting laryngeal exposure, such as tonsil hypertrophy, tongue hypertrophy, vocal coral polyps, laryngeal edema.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Junchao Zhu

Shenyang, 110004, China

Location

Study Officials

  • Yanchao Yang, PHD

    Shengjing Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Junchao Zhu, PHD

CONTACT

+8618940257257zhujunchao1@hotmail.com

Yanchao Yang, PHD

CONTACT

+8618940252916yyc25714104@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 28, 2022

First Posted

March 10, 2022

Study Start

March 1, 2022

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

March 10, 2022

Record last verified: 2022-03

Locations

CN(1)