Therapeutic Procedural ComplicationNCT03392922
A Comparison the Intubation of a Left Sided Double Lumen Tube and Uniblocker
A study testing Uniblocker and Left-sided Double-lumen Tube in people with 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 thoracic surgery to facilitate surgical visualization by collapsing the lung. The double-lumen tube (DLT) and Uniblocker are the commonly used device for OLV.The objective of our study was to comparison the safety and effectiveness of the intubation of the Left-sided… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Therapeutic Procedural Complication
- What is being tested?
- Uniblocker and Left-sided Double-lumen Tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2018to 25 Jun 2018
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients undergoing left side thoracic surgery
Who cannot join
- 1.Age>70 or <18 years 2.ASA classifications >III 3.BMI >35kg/m2 4.Modified Mallampati classification ≥III 5.Thoracic surgery within the last one month 6.Severe cardiopulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison the Intubation of a Left Sided Double Lumen Tube and the Uniblocker Under the Guidence of Chest Computed Tomography Image
One-lung ventilation (OLV) is required for the most thoracic surgery to facilitate surgical visualization by collapsing the lung. The double-lumen tube (DLT) and Uniblocker are the commonly used device for OLV.The objective of our study was to comparison the safety and effectiveness of the intubation of the Left-sided Double-lumen Tube and the Uniblocker under the guidence of chest computed tomography (CT) image.
Read the detailed description
One-lung ventilation (OLV) is required for the most thoracic surgery to facilitate surgical visualization by collapsing the lung. The double-lumen tube (DLT) and Bronchial blockers (BBs) are the commonly used device for OLV.The objective of this study is to comparison the safety and effectiveness of the intubation of the Left-sided Double-lumen Tube and the Uniblocker under the guidence of chest computed tomography (CT) image(the operator count the number of CT slices (slice thickness is 5mm) from vocal cord slice to carina slice to calculate the distance between vocal cord and carina) then measure a distance on the DLT or Uniblocker from the upper edge of the cuff to the mouth side and made a marker on the DLT or Uniblocker.During the intubation the operator insert the DLT or Uniblocker into the trachea via video laryngoscope, after passing the glottis the DLT or Uniblocker are advanced toward the left main-stem bronchus, once the anesthesiologist see the marker on the DLT or the Uniblocker just above the vocal cord stop the insertion.
- Conditions
- Therapeutic Procedural Complication
- Being tested
- Uniblocker, Left-sided Double-lumen Tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UniblockerDevice
The BBs have more advantages than DLT: easier insertion especially in patients with difficult airway18 and no need to exchange the tube when mechanical ventilation is required after surgery.
Left-sided Double-lumen TubeDevice
the double-lumen tube (DLT) is the most commonly used device for OLV
| Study group | Role | What they receive |
|---|---|---|
| Uniblocker | Experimental | The BBs have more advantages than DLT: easier insertion especially in patients with difficult airway18 and no need to exchange the tube when mechanical ventilation is required after surgery Receives: Device: Uniblocker |
| Left-sided Double-lumen Tube | Experimental | the double-lumen tube (DLT) is the most commonly used device for OLV Receives: Device: Left-sided Double-lumen Tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of the optimal position on the first attempt
Measured: 1 year
The incidence of the injuries of bronchi and carina.
Measured: 1 year
Secondary outcomes (4)
The time for the intubation of Uniblocker or Left-sided Double-lumen Tube
Measured: 1 year
The incidence of lung adequacy collapse
Measured: 1 year
The incidence of Uniblocker displacement
Measured: 1 year
The incidence of sore throat and hoarseness postoperative
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start6 Jan 2018
- Primary completion12 May 2018
- Study completion25 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Qinhuangdao
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ximing Qi, Study director, The First Hospital of Qinhuangdao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392922
- Sponsor's protocol ID
- 966168
- Status last verified
- Dec 2017
- First submitted
- 16 Dec 2017
- Last updated
- 8 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu Z, Zhao L, Zhu Y, Bao L, Jia QQ, Yang XC, Liang SJ. The efficacy and adverse effects of the Uniblocker and left-side double-lumen tube for one-lung ventilation under the guidance of chest CT. Exp Ther Med. 2020 Apr;19(4):2751-2756. doi: 10.3892/etm.2020.8492. Epub 2020 Feb 5.
PubMed 32256757
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison the Intubation of a Left Sided Double Lumen Tube and the Uniblocker Under the Guidence of Chest Computed Tomography Image
- ClinicalTrials.gov ID
- NCT03392922
- Acronym / sponsor ID
- 966168
- Conditions
- Therapeutic Procedural Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The First Hospital of QinhuangdaoOther government
- Study start
- 6 Jan 2018 (actual)
- Primary completion
- 12 May 2018 (actual)
- Study completion
- 25 Jun 2018 (actual)
- First posted
- 8 Jan 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 thoracic surgery to facilitate surgical visualization by collapsing the lung. The double-lumen tube (DLT) and Uniblocker are the commonly used device for OLV.The objective of our study was to comparison the safety and effectiveness of the intubation of the Left-sided Double-lumen Tube and the Uniblocker under the guidence of chest computed tomography (CT) image.
Detailed description
One-lung ventilation (OLV) is required for the most thoracic surgery to facilitate surgical visualization by collapsing the lung. The double-lumen tube (DLT) and Bronchial blockers (BBs) are the commonly used device for OLV.The objective of this study is to comparison the safety and effectiveness of the intubation of the Left-sided Double-lumen Tube and the Uniblocker under the guidence of chest computed tomography (CT) image(the operator count the number of CT slices (slice thickness is 5mm) from vocal cord slice to carina slice to calculate the distance between vocal cord and carina) then measure a distance on the DLT or Uniblocker from the upper edge of the cuff to the mouth side and made a marker on the DLT or Uniblocker.During the intubation the operator insert the DLT or Uniblocker into the trachea via video laryngoscope, after passing the glottis the DLT or Uniblocker are advanced toward the left main-stem bronchus, once the anesthesiologist see the marker on the DLT or the Uniblocker just above the vocal cord stop the insertion.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uniblocker | Experimental | Device: UniblockerThe BBs have more advantages than DLT: easier insertion especially in patients with difficult airway18 and no need to exchange the tube when mechanical ventilation is required after surgery |
| Left-sided Double-lumen Tube | Experimental | Device: Left-sided Double-lumen Tubethe double-lumen tube (DLT) is the most commonly used device for OLV |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients undergoing left side thoracic surgery
Key exclusion criteria (1 listed)
- 1.Age>70 or <18 years 2.ASA classifications >III 3.BMI >35kg/m2 4.Modified Mallampati classification ≥III 5.Thoracic surgery within the last one month 6.Severe cardiopulmonary disease
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 |
|---|---|---|
| UniblockerThe BBs have more advantages than DLT: easier insertion especially in patients with difficult airway18 and no need to exchange the tube when mechanical ventilation is required after surgery. | Device | Uniblocker |
| Left-sided Double-lumen Tubethe double-lumen tube (DLT) is the most commonly used device for OLV | Device | Left-sided Double-lumen Tube |
Primary outcome
The incidence of the optimal position on the first attempt
Time frame: 1 year
The incidence of the injuries of bronchi and carina.
Time frame: 1 year
4 secondary outcomes
The time for the intubation of Uniblocker or Left-sided Double-lumen Tube
Time frame: 1 year
The incidence of lung adequacy collapse
Time frame: 1 year
The incidence of Uniblocker displacement
Time frame: 1 year
The incidence of sore throat and hoarseness postoperative
Time frame: 1 year
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 8 Jan 2019.
- Derived from this study: PubMed 32256757Liu Z, Zhao L, Zhu Y, Bao L, Jia QQ, Yang XC, Liang SJ. The efficacy and adverse effects of the Uniblocker and left-side double-lumen tube for one-lung ventilation under the guidance of chest CT. Exp Ther Med. 2020 Apr;19(4):2751-2756. doi: 10.3892/etm.2020.8492. Epub 2020 Feb 5.
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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.
Ximing Qi study director
The First Hospital of Qinhuangdao
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uniblocker and Left-sided Double-lumen Tube in people with 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 1 inclusion and 1 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 8 Jan 2019. 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 optimal position on the first attempt (time frame: 1 year). 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?
On the ClinicalTrials.gov record for NCT03392922, which also lists 1 linked publication.
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 8 Jan 2019.