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.
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
- Conditions the study is for
- Ultrasound Therapy; Complications, Transverse Diameter of Cricoid Cartilage, Endotracheal Intubation
- 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.
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.
- Conditions
- Ultrasound Therapy; Complications, Transverse Diameter of Cricoid Cartilage, Endotracheal Intubation, Children
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of endotracheal intubation
The single success rate of endotracheal intubation between the two groups
Measured: 24 hours after surgery
The during time of tracheal intubation
Time required for endotracheal intubation
Measured: 24 hours after surgery
Secondary outcomes (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.
- First posted10 Mar 2022
- Study start1 Mar 2022 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound Therapy; ComplicationsStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanchao Yang, Shengjing Hospital
- Investigators
- Yanchao Yang, PHD, Principal investigator, Shengjing Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Measurements of Circular Cartilage Transverse Diameter Were Used for the Selection of Surgical Tracheal Catheter in Younger Children
- ClinicalTrials.gov ID
- NCT05273294
- Acronym / sponsor ID
- Ultrasound measurements
- Conditions
- Ultrasound Therapy; Complications, Transverse Diameter of Cricoid Cartilage, Endotracheal Intubation, Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound group | Experimental | Device: Portable color Doppler ultrasound systemAnesthesiologist 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. |
| 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). |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children under 1 year old who received selective general anesthesia for endotracheal intubation in Shengjing Hospital affiliated to China Medical University.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portable color Doppler ultrasound systemIn 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 | Device | Ultrasound group |
Primary outcome
Success rate of endotracheal intubation
Time frame: 24 hours after surgery
The single success rate of endotracheal intubation between the two groups
The during time of tracheal intubation
Time frame: 24 hours after surgery
Time required for endotracheal intubation
1 secondary outcome
Complications of endotracheal intubation
Time frame: 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanchao Yang, PHD principal investigator
Shengjing Hospital
1 site in 1 country: see every site and its status.
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.