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Ultrasound Therapy; ComplicationsNCT05273294

Ultrasound Measurements of Circular Cartilage Transverse Diameter

A study testing Portable color Doppler ultrasound system in people with Ultrasound Therapy; Complications and Transverse Diameter of Cricoid Cartilage, run by Shengjing Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 1 month to 12 months
What is being tested?
Portable color Doppler ultrasound system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteChina
Study dates
1 Mar 2022to 1 Jul 2022
Phase
Interventional
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 1 month to 12 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Yanchao Yang, PHD contact

+8618940252916

yyc25714104@163.com

China1 site
  • Junchao Zhu

    Shenyang, 110004

Other trials in China

About this study

Official title: Ultrasound Measurements of Circular Cartilage Transverse Diameter Were Used for the Selection of Surgical Tracheal Catheter in Younger Children

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.

Read the detailed description

A total of 90 children younger than 1 year old who underwent endotracheal intubation under elective general anesthesia in Shengjing Hospital affiliated to China Medical University from January 2022 to June 2022.Ninety patients were randomized by placing the numbers of the experimental and control patients in opaque envelopes in patient order.After having the envelope sealed and scrambled, number it in the order of 1 to 2.When each new patient entered the study, an envelope was opened and entered according to the allocation protocol in the envelope.The procedure was repeated for the patients in each group.The Informed consent was signed by an uninformed anesthesia assistant, and all patients included in the experiment and their families were unaware of the grouping.Of these, 47 were male, 43 females, ASA grade I or II, age less than 1 year, height (63.6±9.13) cm, and weight (7.55±7.37) kg.

All children with routine preoperative fasting, postoperative monitoring monitoring electrocardiogram (ECG), blood pressure (BP) and blood oxygen saturation (SPO2), mask oxygen inhalation, maintain SPO298%, intravenous induction, intravenous sufentanil 2ug/kg, Etomidate 0.2mg/kg, rouronium 0.6mg/kg, manually assisted ventilation until muscle release completely started.Ultrasonic measurement group, the anesthesiologist, who was trained by professional physician and not know the study plan, will probe ultrasonic probe with coupling agent after long axis with the neck on the sternoclavicular articulation point 0.5 cm place to get the cricoOD cartilage parallel plane image, obtain patients expiratory pause at the end of the clearance of cricoOD cartilage ring diameter image, the average value was taken after obtaining repeated measurements 3 times. Select the tracheal duct model based on the measured transverse diameter of circular cartilage, That is, the largest tracheal tube with an outer diameter smaller than the transverse diameter of the circular cartilage, Perform tracheal intubation, Determine whether the catheter model is suitable according to the air leakage test.Air leakage test: the sleeve is not inflated, adjust the oxygen flow of the anesthesia machine by 3.0 L/min, adjust the pressure preset of the APL valve, if the pressure of the APL valve is set to 10cm H2O; if the pressure of the APL valve is set to 20cm H2O, the diameter is too large to be clinically suitable in between.Double lung ausculatory respiratory sound symmetry to determine intubation depth, adjust depth for post-fixation catheter, mechanical ventilation, pressure control ventilation mode, pressure of 10-20cm H2O, respiratory of 22-24 beats/min, adjusted to intraoperative PetCO2 levels to maintain it at 35-45mmHg.The measurement of circular cartilage transverse diameter, tracheal intubation operation and anesthesia management operation of the above children were completed by two skilled anesthesiologists, and the data were recorded.Radial and internal jugular vein puncture was performed, and immediate arterial pressure and central venous pressure were measured.

Selection of tracheal catheter type:

Ultrasound group: 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.The outer diameter of the endotracheal catheter used in Shengjing Hospital, China Medical University is shown in Table 4.

Control group: 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).

Observation and record index:

The success rate of complete intubation, the time required for endotracheal intubation, the number of tracheal intubation attempts, and the complications were recorded.Statistical analysis was conducted between the transverse diameter, age, height and weight and the outer diameter (The outer diameter, OD).The time of tracheal intubation in this study was calculated from the completion of oxygen inhalation immediately after the insertion into the laryngeal lens to the successful insertion of the appropriate tracheal catheter.

Being tested
Portable color Doppler ultrasound system

What participants receive

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

  • 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

Study groups in NCT05273294
Study groupRoleWhat they receive
Ultrasound groupExperimentalAnesthesiologist 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.
Receives: Device: Portable color Doppler ultrasound system
Control groupNo interventiontracheal 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).

What is being measured

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

  1. Success rate of endotracheal intubation

    The single success rate of endotracheal intubation between the two groups

    Measured: 24 hours after surgery

  2. The during time of tracheal intubation

    Time required for endotracheal intubation

    Measured: 24 hours after surgery

Secondary outcomes (1)
  1. Complications of endotracheal intubation

    Tracheal intubation-related complications were recorded within 24 hours after surgery

    Measured: 24 hours 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 posted10 Mar 2022
  2. Study start1 Mar 2022 (estimated)
  3. Primary completion1 Jul 2022 (estimated)
  4. Study completion1 Jul 2022 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05273294
Sponsor's protocol ID
Ultrasound measurements
Status last verified
Mar 2022
First submitted
28 Feb 2022
Last updated
10 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Portable color Doppler ultrasound system in people with Ultrasound Therapy; Complications and Transverse Diameter of Cricoid Cartilage, run by Shengjing Hospital 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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 10 Mar 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?

Results are not available in the source record.

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

Contact Junchao Zhu, PHD (+8618940257257, zhujunchao1@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success rate of endotracheal intubation (time frame: 24 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 10 Mar 2022.

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