Therapeutic Procedural ComplicationNCT05739318
the Diameter of Double-lumen Tube Measured by Different Methods
A study testing The cuff of endotracheal and endobronchial is collapsed and The cuff of endotracheal and endobronchial is inflated in people with Therapeutic Procedural Complication, run by The First Hospital of Qinhuangdao at 1 site in China.
Trial summary
The comparison of the diameter of double-lumen tube at the cuff of endotracheal and endobronchial during the cuff was collapse or inflated as a guide for the selection of the size of double-lumen tube. 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?
- The cuff of endotracheal and endobronchial is collapsed and The cuff of endotracheal and endobronchial is inflated
- 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
- 15 Feb 2023to 3 Aug 2023
- 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
- BMI less than 35 kg/m2 ASA classifications of I-III, Modified Mallampati classification 1 or 2 Under general anesthesia
Who cannot join
- Age younger than 18 yr or older than 70 yr
- ASA class IV or V
- Abnormalities of the heart, brain, liver, lung, kidney and coagulation function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Accuracy of the Diameter of Double-lumen Tube Measured by Different Methods as a Guide to the Size Selection of Double-lumen Tube
The comparison of the diameter of double-lumen tube at the cuff of endotracheal and endobronchial during the cuff was collapse or inflated as a guide for the selection of the size of double-lumen tube.
Read the detailed description
The comparison of the diameter of double-lumen tube at the cuff of endotracheal and endobronchial during the cuff was collapse or inflated as a guide for the selection of the size of double-lumen tube.
- Conditions
- Therapeutic Procedural Complication
- Being tested
- The cuff of endotracheal and endobronchial is collapsed, The cuff of endotracheal and endobronchial is inflated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The cuff of endotracheal and endobronchial is collapsedDevice
The diameter of double-lumen tube at the cuff of endotracheal and endobronchial when the cuff is collapsed as the diameter of double-lumen tube and select a double-lumen tube that matches the patient's trachea and bronchial innerdiameter based on this diameter
The cuff of endotracheal and endobronchial is inflatedDevice
The diameter of double-lumen tube at the cuff of endotracheal and endobronchial when the cuff is inflated as the diameter of double-lumen tube and select a double-lumen tube that matches the patient's trachea and bronchial innerdiameter based on this diameter
| Study group | Role | What they receive |
|---|---|---|
| The cuff of endotracheal and endobronchial is collapsed | Experimental | The diameter of double-lumen tube at the cuff of endotracheal and endobronchial during the cuff is collapsed Receives: Device: The cuff of endotracheal and endobronchial is collapsed |
| The cuff of endotracheal and endobronchial is inflated | Experimental | The diameter of double-lumen tube at the cuff of endotracheal and endobronchial during the cuff is inflated Receives: Device: The cuff of endotracheal and endobronchial is inflated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complications
Incidence of postoperative hoarseness and throat pain in patients
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start15 Feb 2023
- Primary completion30 Jul 2023
- Study completion3 Aug 2023
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
- Treatment
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739318
- Sponsor's protocol ID
- 2022A123
- Status last verified
- Feb 2023
- First submitted
- 9 Feb 2023
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cui G, Zhao L, Chi C, Liang S, Liu Z. The feasibility and accuracy of the method for selecting the optimal size of double-lumen tube in thoracic surgery: a prospective, randomized controlled trial. Sci Rep. 2024 Jul 30;14(1):17539. doi: 10.1038/s41598-024-68349-z.
PubMed 39080380
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of the Diameter of Double-lumen Tube Measured by Different Methods as a Guide to the Size Selection of Double-lumen Tube
- ClinicalTrials.gov ID
- NCT05739318
- Acronym / sponsor ID
- 2022A123
- Conditions
- Therapeutic Procedural Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The First Hospital of QinhuangdaoOther government
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 3 Aug 2023 (actual)
- First posted
- 22 Feb 2023 (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.
The comparison of the diameter of double-lumen tube at the cuff of endotracheal and endobronchial during the cuff was collapse or inflated as a guide for the selection of the size of double-lumen tube.
Detailed description
The comparison of the diameter of double-lumen tube at the cuff of endotracheal and endobronchial during the cuff was collapse or inflated as a guide for the selection of the size of double-lumen tube.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The cuff of endotracheal and endobronchial is collapsed | Experimental | Device: The cuff of endotracheal and endobronchial is collapsedThe diameter of double-lumen tube at the cuff of endotracheal and endobronchial during the cuff is collapsed |
| The cuff of endotracheal and endobronchial is inflated | Experimental | Device: The cuff of endotracheal and endobronchial is inflatedThe diameter of double-lumen tube at the cuff of endotracheal and endobronchial during the cuff is inflated |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI less than 35 kg/m2 ASA classifications of I-III, Modified Mallampati classification 1 or 2 Under general anesthesia
Key exclusion criteria (3 listed)
- Age younger than 18 yr or older than 70 yr
- ASA class IV or V
- Abnormalities of the heart, brain, liver, lung, kidney and coagulation function
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 |
|---|---|---|
| The cuff of endotracheal and endobronchial is collapsedThe diameter of double-lumen tube at the cuff of endotracheal and endobronchial when the cuff is collapsed as the diameter of double-lumen tube and select a double-lumen tube that matches the patient's trachea and bronchial innerdiameter based on this diameter | Device | The cuff of endotracheal and endobronchial is collapsed |
| The cuff of endotracheal and endobronchial is inflatedThe diameter of double-lumen tube at the cuff of endotracheal and endobronchial when the cuff is inflated as the diameter of double-lumen tube and select a double-lumen tube that matches the patient's trachea and bronchial innerdiameter based on this diameter | Device | The cuff of endotracheal and endobronchial is inflated |
Primary outcome
Incidence of complications
Time frame: 12 weeks
Incidence of postoperative hoarseness and throat pain in patients
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 1 May 2024.
- Derived from this study: PubMed 39080380Cui G, Zhao L, Chi C, Liang S, Liu Z. The feasibility and accuracy of the method for selecting the optimal size of double-lumen tube in thoracic surgery: a prospective, randomized controlled trial. Sci Rep. 2024 Jul 30;14(1):17539. doi: 10.1038/s41598-024-68349-z.
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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?
A study testing The cuff of endotracheal and endobronchial is collapsed and The cuff of endotracheal and endobronchial is inflated 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 3 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 1 May 2024. 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?
Incidence of complications (time frame: 12 weeks). 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 NCT05739318, 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 1 May 2024.