Therapeutic Procedural ComplicationNCT03545737
Compare a New Method and Formula as a Guide for the Intubation of a Left-sided Double-lumen Tube
An observational study of Therapeutic Procedural Complication, run by The First Hospital of Qinhuangdao at 1 site in China.
Trial summary
One-lung ventilation (OLV) is required for the most of thoracic surgery to facilitate surgical visualization by collapsing the lung. The double-lumen tube (DLT) is the commonly used device for OLV. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Therapeutic Procedural Complication
- What is being tested?
- Measurement and Formula
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2018to 13 Dec 2018
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Age<18 or >70 years 2. ASA>III; BMI>35kg/m2 3. Without suspected tuberculosis or systemic infection 4. Without severe cardiopulmonary disease, preoperative hoarseness and anticipated difficult airway
Who may be able to join
- Adult patients undergoing elective left side thoracic surgery
- Requiring a Uniblocker or DLT for one-lung ventilation
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compare the Accuracy of the Distances Between the Midpoint of the Thyroid Cartilage to Suprasternal Notch Base on Body Surface Measurement Add the Distance Between Suprasternal Notch to Carina of Trachea According to Chest CT and Formula Base on Patient's Height as a Guide for the Intubation of a Left-sided Double-lumen Tube
One-lung ventilation (OLV) is required for the most of thoracic surgery to facilitate surgical visualization by collapsing the lung. The double-lumen tube (DLT) is the commonly used device for OLV. The objective of this study was to compare the accuracy of the distances between vocal cords to carina of trachea and formula base on patient's height as a guide for the intubation of a Left-sided Double-lumen tube
Read the detailed description
In previous study, investigators found that the distances between vocal cords to carina of trachea was a useful predictive method for the intubation of a Left-sided Double-lumen tube. However in some hospitals preoperative chest CT scans not contain the vocal cords slice. So in this study investigators will compare the accuracy of the distances between the midpoint of the thyroid cartilage to suprasternal notch base on body surface measurement add the distance between suprasternal notch to carina of trachea according to chest CT and formula base on patient's height as a guide for the intubation of a Left-sided Double-lumen tube.
- Conditions
- Therapeutic Procedural Complication
- Being tested
- Measurement, Formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeasurementOther
The distances between the midpoint of the thyroid cartilage to suprasternal notch base on body surface measurement add the distance between suprasternal notch to carina of trachea according to chest CT
FormulaOther
The formula base on patient's height as a guide for the intubation of a Left-sided Double-lumen tube
| Study group | Role | What they receive |
|---|---|---|
| Measurement | The distances between the midpoint of the thyroid cartilage to suprasternal notch base on body surface measurement add the distance between suprasternal notch to carina of trachea according to chest CT. Receives: Other: Measurement | |
| Formula | The formula base on patient's height as a guide for the intubation of a Left-sided Double-lumen tube.
The depth of intubation = 0.1977* height-4.2423 Receives: Other: Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of the injuries of bronchi and carina
The degree of bronchi and carina injuries: 1 clear; 2 a few petechiae; 3coalesced petechiae, hemorrhage, or ecchymosis; 4 erosion
Measured: 1-3days
Secondary outcomes (2)
The incidence of dislodgement
The incidence of dislodgement after repositioning
Measured: 1 day
The intubation time
The intubation time (IT) was defined as the time from the anesthesiologist inserted the video laryngoscope between the teeth of patients until the double lumen-tube at the optimal position checked by Fiberoptic bronchoscopy
Measured: 1-5min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start15 Jun 2018
- Primary completion21 Nov 2018
- Study completion13 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapeutic Procedural ComplicationStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Qinhuangdao
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545737
- Sponsor's protocol ID
- 98776
- Status last verified
- Feb 2023
- First submitted
- 15 May 2018
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Accuracy of the Distances Between the Midpoint of the Thyroid Cartilage to Suprasternal Notch Base on Body Surface Measurement Add the Distance Between Suprasternal Notch to Carina of Trachea According to Chest CT and Formula Base on Patient's Height as a Guide for the Intubation of a Left-sided Double-lumen Tube
- ClinicalTrials.gov ID
- NCT03545737
- Acronym / sponsor ID
- 98776
- Conditions
- Therapeutic Procedural Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The First Hospital of QinhuangdaoOther government
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 21 Nov 2018 (actual)
- Study completion
- 13 Dec 2018 (actual)
- First posted
- 4 Jun 2018 (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.
One-lung ventilation (OLV) is required for the most of thoracic surgery to facilitate surgical visualization by collapsing the lung. The double-lumen tube (DLT) is the commonly used device for OLV. The objective of this study was to compare the accuracy of the distances between vocal cords to carina of trachea and formula base on patient's height as a guide for the intubation of a Left-sided Double-lumen tube
Detailed description
In previous study, investigators found that the distances between vocal cords to carina of trachea was a useful predictive method for the intubation of a Left-sided Double-lumen tube. However in some hospitals preoperative chest CT scans not contain the vocal cords slice. So in this study investigators will compare the accuracy of the distances between the midpoint of the thyroid cartilage to suprasternal notch base on body surface measurement add the distance between suprasternal notch to carina of trachea according to chest CT and formula base on patient's height as a guide for the intubation of a Left-sided Double-lumen tube.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Measurement | – | Other: MeasurementThe distances between the midpoint of the thyroid cartilage to suprasternal notch base on body surface measurement add the distance between suprasternal notch to carina of trachea according to chest CT. |
| Formula | – | Other: FormulaThe formula base on patient's height as a guide for the intubation of a Left-sided Double-lumen tube. The depth of intubation = 0.1977* height-4.2423 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Age<18 or >70 years 2. ASA>III; BMI>35kg/m2 3. Without suspected tuberculosis or systemic infection 4. Without severe cardiopulmonary disease, preoperative hoarseness and anticipated difficult airway
Key inclusion criteria (2 listed)
- Adult patients undergoing elective left side thoracic surgery
- Requiring a Uniblocker or DLT for one-lung ventilation
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| MeasurementThe distances between the midpoint of the thyroid cartilage to suprasternal notch base on body surface measurement add the distance between suprasternal notch to carina of trachea according to chest CT | Other | Measurement |
| FormulaThe formula base on patient's height as a guide for the intubation of a Left-sided Double-lumen tube | Other | Formula |
Primary outcome
The incidence of the injuries of bronchi and carina
Time frame: 1-3days
The degree of bronchi and carina injuries: 1 clear; 2 a few petechiae; 3coalesced petechiae, hemorrhage, or ecchymosis; 4 erosion
2 secondary outcomes
The incidence of dislodgement
Time frame: 1 day
The intubation time
Time frame: 1-5min
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 15 Feb 2023.
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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 Therapeutic Procedural Complication, run by The First Hospital of Qinhuangdao 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 2 inclusion and 0 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 15 Feb 2023. 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 incidence of the injuries of bronchi and carina (time frame: 1-3days). 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 15 Feb 2023.