Endotracheal IntubationNCT01628978
Verification of Appropriate Insertion Depth of Endotracheal Tube Placement
An observational study of Endotracheal Intubation and Infants or Young Children, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The investigators are trying to evaluate the efficacy of ultrasonographic determination of depth of endotracheal tube placement in infants and young children by using the pleural sliding sign. Read more about this study
- Who is it for?
- Ages 1 month to 10 years
- Conditions the study is for
- Endotracheal Intubation, Infants or Young Children
- What is being tested?
- determination by auscultation and determination by ultrasound
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2012to Jun 2015
- 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 1 month to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Infants or young children (less than body weight of 20 kg) undergoing elective surgery (general surgery, urology, plastic surgery, otolaryngologic surgery, cardiac surgery) under general anesthesia with endotracheal intubation
Who may be able to join
- Infants or young children (less than body weight of 20 kg) undergoing elective surgery (general surgery, urology, plastic surgery, cardiac surgery) under general anesthesia with endotracheal intubation
Who cannot join
- Patients with pneumothorax, pleural effusion, atelectasis, pneumonia
- hemodynamic unstable patients (inotropics use)
- History of difficult intubation
- Combined upper airway anomaly
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 135-710
Sangmin M. Lee, MD, PhD, 82-2-3410-0362, sangminm.lee@samsung.com
Won Ho Kim, MD, 82-2-3410-1994, bullet57@naver.com
About this study
Official title: Verification of Appropriate Insertion Depth of Endotracheal Tube Placement in Infants and Young Children by Ultrasonography
The investigators are trying to evaluate the efficacy of ultrasonographic determination of depth of endotracheal tube placement in infants and young children by using the pleural sliding sign.
Read the detailed description
It is difficult to determine the adequate depth of endotracheal tube placement in infants and young children. It is usually determined by an equation according to the patient's age (12 + age/2, cm) or auscultation method. The auscultation method is to intentionally place the tip of the endotracheal tube into the right main stem bronchus and then withdraw it until breath sounds are equal. The tube is fixed 1 or 2 cm proximal to the point where breath sounds become equal. However, in small children or infant, as the breadth sound in unilateral lung transmits the contralateral lung field and is often difficult to listen in a noisy operation room, it is often difficult to determine the depth by auscultation method. Pleural sliding sign, or sliding lung sign is a ultrasonographic finding that the visceral pleura moves against the parietal pleura. It is used to identify whether the lung is ventilated by ultrasound. The investigators are trying to use this pleural sliding sign to determine the depth of endotracheal tube, and compare this method with auscultation method.
- Conditions
- Endotracheal Intubation, Infants or Young Children
- Being tested
- determination by auscultation, determination by ultrasound
- Keywords
- depth of endotracheal tube placement, endotracheal intubation, endobronchial intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
determination by auscultationOther
Also called auscultation
determination of depth of endotracheal tube placement by auscultation
determination by ultrasoundOther
Also called H-Universal Stand (sonosite, Bothell, WA, USA)
determination of depth of endotracheal tube placement by ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Auscultation group | The depth of endotracheal tube placement is determined by auscultation. Receives: Other: determination by auscultation | |
| Ultrasonography group | The depth of placement of endotracheal tube placement is determined by ultrasonographic finding of pleural sliding sign. Receives: Other: determination by ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of inadequate depth of endotracheal tube placement by flexible brochoscopy after intubation
the incidence of inadequate depth of endotracheal tube placement by flexible bronchoscopy 3 minute after intubation
Measured: 3 minutes after intubation
Secondary outcomes (5)
incidence of repositioning of endotracheal tube placement
incidence of repositioning of endotracheal tube placement (when it is found that the depth of endotracheal tube placement was inadequate determined by saturation fall or airway pressure monitoring)
Measured: 10 min after anesthetic induction
time to verification of appropriate insertion depth of endotracheal tube placement
time to verification of appropriate insertion depth of endotracheal tube placement by a independent observer
Measured: 30 minutes after the end of surgery
blood pressure
systolic, diastolic, mean blood pressure before attempt of endotracheal intubation (5 min), during determining the depth of endotracheal tube placement (10 min), after determining the depth of endotracheal tube placement (20 min)
Measured: 5, 10, 20 min after anesthetic induction
heart rate
heart rate before attempt of endotracheal intubation (5 min), during determining the depth of endotracheal tube placement (10 min), after determining the depth of endotracheal tube placement (20 min)
Measured: 5, 10, 20 min after anesthetic induction
pulse oximetry
pulse oximetry before attempt of endotracheal intubation (5 min), during determining the depth of endotracheal tube placement (10 min), after determining the depth of endotracheal tube placement (20 min)
Measured: 5, 10, 20 min after anesthetic induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal IntubationStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sangmin M. Lee, Samsung Medical Center
- Investigators
- Sangmin M. Lee, MD, PhD, Principal investigator, Samsung Medical CenterWon Ho Kim, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628978
- Sponsor's protocol ID
- 2012-05-028-001
- Status last verified
- Nov 2014
- First submitted
- 24 Jun 2012
- Last updated
- 11 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verification of Appropriate Insertion Depth of Endotracheal Tube Placement in Infants and Young Children by Ultrasonography
- ClinicalTrials.gov ID
- NCT01628978
- Acronym / sponsor ID
- 2012-05-028-001
- Conditions
- Endotracheal Intubation, Infants or Young Children
- Keywords
- depth of endotracheal tube placement, endotracheal intubation, endobronchial intubation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 27 Jun 2012 (estimated)
- 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.
The investigators are trying to evaluate the efficacy of ultrasonographic determination of depth of endotracheal tube placement in infants and young children by using the pleural sliding sign.
Detailed description
It is difficult to determine the adequate depth of endotracheal tube placement in infants and young children. It is usually determined by an equation according to the patient's age (12 + age/2, cm) or auscultation method. The auscultation method is to intentionally place the tip of the endotracheal tube into the right main stem bronchus and then withdraw it until breath sounds are equal. The tube is fixed 1 or 2 cm proximal to the point where breath sounds become equal. However, in small children or infant, as the breadth sound in unilateral lung transmits the contralateral lung field and is often difficult to listen in a noisy operation room, it is often difficult to determine the depth by auscultation method. Pleural sliding sign, or sliding lung sign is a ultrasonographic finding that the visceral pleura moves against the parietal pleura. It is used to identify whether the lung is ventilated by ultrasound. The investigators are trying to use this pleural sliding sign to determine the depth of endotracheal tube, and compare this method with auscultation method.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auscultation group | – | Other: determination by auscultationThe depth of endotracheal tube placement is determined by auscultation. |
| Ultrasonography group | – | Other: determination by ultrasoundThe depth of placement of endotracheal tube placement is determined by ultrasonographic finding of pleural sliding sign. |
Who may qualify
- Ages
- 1 month to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants or young children (less than body weight of 20 kg) undergoing elective surgery (general surgery, urology, plastic surgery, otolaryngologic surgery, cardiac surgery) under general anesthesia with endotracheal intubation
Key inclusion criteria (1 listed)
- Infants or young children (less than body weight of 20 kg) undergoing elective surgery (general surgery, urology, plastic surgery, cardiac surgery) under general anesthesia with endotracheal intubation
Key exclusion criteria (4 listed)
- Patients with pneumothorax, pleural effusion, atelectasis, pneumonia
- hemodynamic unstable patients (inotropics use)
- History of difficult intubation
- Combined upper airway anomaly
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 |
|---|---|---|
| determination by auscultationAlso: auscultationdetermination of depth of endotracheal tube placement by auscultation | Other | Auscultation group |
| determination by ultrasoundAlso: H-Universal Stand (sonosite, Bothell, WA, USA)determination of depth of endotracheal tube placement by ultrasound | Other | Ultrasonography group |
Primary outcome
the incidence of inadequate depth of endotracheal tube placement by flexible brochoscopy after intubation
Time frame: 3 minutes after intubation
the incidence of inadequate depth of endotracheal tube placement by flexible bronchoscopy 3 minute after intubation
5 secondary outcomes
incidence of repositioning of endotracheal tube placement
Time frame: 10 min after anesthetic induction
time to verification of appropriate insertion depth of endotracheal tube placement
Time frame: 30 minutes after the end of surgery
blood pressure
Time frame: 5, 10, 20 min after anesthetic induction
heart rate
Time frame: 5, 10, 20 min after anesthetic induction
pulse oximetry
Time frame: 5, 10, 20 min after anesthetic induction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2014.
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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.
Sangmin M. Lee, MD, PhD principal investigator
Samsung Medical Center
Won Ho Kim, MD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endotracheal Intubation and Infants or Young Children, run by Samsung Medical Center at 1 site in South Korea.
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 4 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 11 Nov 2014. 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 South Korea. 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 Sangmin M. Lee, MD, PhD (82-2-3410-0362, sangminm.lee@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of inadequate depth of endotracheal tube placement by flexible brochoscopy after intubation (time frame: 3 minutes after intubation). 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 11 Nov 2014.