Endotracheal IntubationNCT03878797
The Depth of Endotracheal Tube Insertion
An observational study of Endotracheal Intubation, run by Gao Mei at 1 site in China.
Trial summary
Virtual experiment : comparing the new method with conventional method of determining the depth of endotracheal intubation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Endotracheal Intubation
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2019to 26 Dec 2019
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: adult patients who are scheduled for elective surgery under general anesthesia
Who may be able to join
- Patients who are scheduled for elective surgery under general anesthesia
Who cannot join
- Patients with anatomical defects of the face, neck, or upper airway
- Patients at risk for pulmonary aspiration of gastric content
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
Official title: An Observational Study of The Depth of Endotracheal Tube Insertion
Virtual experiment : comparing the new method with conventional method of determining the depth of endotracheal intubation.
Read the detailed description
Effective airway management is the primary concern of the anesthesiologist. The conventional method of determining the insertion length of the endotracheal tube, 21 cm for women and 23 cm for men, shows a high incidence of endobronchial intubations in the analyzed population.The aim of this study is form a new and safe practice habit by passing the endotracheal tube with the balloon just 2 cm below the vocal cords during intubation.
- Conditions
- Endotracheal Intubation
- Keywords
- Endotracheal tube, Endobronchial intubation, Vocal cords, Bronchoscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
the depth of primary insertion of tracheal tube
Measured: in a minute after intubation
Secondary outcomes (3)
the distance from the corner of mouth to the carina
Measured: in a minute after intubation
the distance from the vocal cords to the carina
Measured: in a minute after intubation
the distance from the corner of mouth to the vocal cords
Measured: in a minute after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start20 May 2019
- Primary completion26 Dec 2019
- Study completion26 Dec 2019
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.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gao Mei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gao Mei, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878797
- Sponsor's protocol ID
- 2019-SR-041
- Status last verified
- Jan 2020
- First submitted
- 15 Mar 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of The Depth of Endotracheal Tube Insertion
- ClinicalTrials.gov ID
- NCT03878797
- Acronym / sponsor ID
- 2019-SR-041
- Conditions
- Endotracheal Intubation
- Keywords
- Endotracheal tube, Endobronchial intubation, Vocal cords, Bronchoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Gao MeiUniversity, hospital or other
- Study start
- 20 May 2019 (actual)
- Primary completion
- 26 Dec 2019 (actual)
- Study completion
- 26 Dec 2019 (actual)
- First posted
- 18 Mar 2019 (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.
Virtual experiment : comparing the new method with conventional method of determining the depth of endotracheal intubation.
Detailed description
Effective airway management is the primary concern of the anesthesiologist. The conventional method of determining the insertion length of the endotracheal tube, 21 cm for women and 23 cm for men, shows a high incidence of endobronchial intubations in the analyzed population.The aim of this study is form a new and safe practice habit by passing the endotracheal tube with the balloon just 2 cm below the vocal cords during intubation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- adult patients who are scheduled for elective surgery under general anesthesia
Key inclusion criteria (1 listed)
- Patients who are scheduled for elective surgery under general anesthesia
Key exclusion criteria (2 listed)
- Patients with anatomical defects of the face, neck, or upper airway
- Patients at risk for pulmonary aspiration of gastric content
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the depth of primary insertion of tracheal tube
Time frame: in a minute after intubation
3 secondary outcomes
the distance from the corner of mouth to the carina
Time frame: in a minute after intubation
the distance from the vocal cords to the carina
Time frame: in a minute after intubation
the distance from the corner of mouth to the vocal cords
Time frame: in a minute after intubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Gao Mei 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 2 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: finished, as of the sponsor's last update on 18 Jan 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the depth of primary insertion of tracheal tube (time frame: in a minute 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 18 Jan 2020.