Intubation TimesNCT06709118
The Effect of Different Fiberoptic Outer Diameters on Fiberoptic Intubation
An observational study of Intubation Times, run by Qinye Shi.
Trial summary
Fiberoptic intubation is an important method for anesthesiologists to deal with difficult airways, but its operation is difficult and requires repeated practice. Fiberoptic intubation is performed in two steps. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation Times
- What is being tested?
- fiberoptic
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2024to 31 Oct 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult
Study population: Patients in need of oral tube intubation and general anesthesia in our hospital for elective surgery
Who may be able to join
- 1.American Society of Anesthesiologists 1~2
- 2.18-60 year
- 3.Adult patients requiring general anesthesia for orotracheal intubation
Who cannot join
- Limited mouth opening
- limited movement of temporomandibular joint
- abnormal glottic anatomy
- polyps of vocal cords
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Fiberoptic intubation is an important method for anesthesiologists to deal with difficult airways, but its operation is difficult and requires repeated practice. Fiberoptic intubation is performed in two steps. First, the anesthesiologist holds the bronchoscope and exposes the base of the tongue, the epiglottis, and the glottis successively according to the front camera of the bronchoscope. Through the glottis, the main trachea is exposed to the carina. This process is visual and the anesthesiologist can see the main tissue structure directly. Then, the endotracheal catheter enters the endotracheal along the bronchoscope, and the process of endotracheal catheter entry is not visual.
In clinical work, it was found that the tracheal catheter was easily blocked when it passed through the glottis, and it was necessary to adjust the position of the tracheal catheter for several times before the tracheal catheter could be sent into the tracheal tube, which was easy to cause throat injury in the process. At present, relevant studies are mainly focused on the first step of bronchoscopic intubation, how to quickly expose the glottis and complete the bronchoscopic guidance process. However, there is no clear mention of the situation of catatoning in the process of endotracheal catheter and how to solve the problem of catatoning.
Read the detailed description
According to the inclusion and exclusion criteria，collecting the data of participants who undergone fiberoptic intubation. The observer analysis the safety and efficiency of fiberoptic intubation.
- Conditions
- Intubation Times
- Being tested
- fiberoptic
- Keywords
- Intubation, Ffiberoptic, Perioperative, Sore throat, Success rate
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fiberopticDevice
Tracheal intubation was performed with different outer diameters of fiberoptic.
| Study group | Role | What they receive |
|---|---|---|
| 3.8mm Group | Orotracheal intubation was performed with a 3.8 millimeter outer diameter fiberoptic Receives: Device: fiberoptic | |
| 2.8 mm group | Orotracheal intubation was performed with a 2.8 millimeter outer diameter fiberoptic Receives: Device: fiberoptic | |
| 4.8mm group | Orotracheal intubation was performed with a 4.8 millimeter outer diameter fiberoptic Receives: Device: fiberoptic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fiberoptic intubation attempts
This is used to observe the passage of the tracheal tube through the glottis
Measured: during the procedure
First intubation success rate
The incidence of tracheal tube through the vocal cords
Measured: during the procedure
Fiberoptic intubation time
The duration of the intubation process
Measured: during the procedure
Time of passage of tracheal intubation through glottis
The time the tracheal tube enters the trachea
Measured: during the procedure
Secondary outcomes (2)
Hoarseness after surgery
Patients were asked about voice changes 24 hours after surgery
Measured: 24 hours after surgery
Sore throat
Patients were asked about throat pain 24 hours after surgery
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start10 Dec 2024 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intubation TimesStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Qinye Shi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qinye Shi, The Fourth Affiliated Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709118
- Sponsor's protocol ID
- KY-2024-172
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Piegeler T, Clausen NG, Weiss M. Effectiveness of tip rotation in fibreoptic bronchoscopy under different experimental conditions: an in vitro crossover study. Br J Anaesth. 2017 Dec 1;119(6):1206-1212. doi: 10.1093/bja/aex322.
PubMed 29028928Karmali S, Rose P. Tracheal tube size in adults undergoing elective surgery - a narrative review. Anaesthesia. 2020 Nov;75(11):1529-1539. doi: 10.1111/anae.15041. Epub 2020 May 16.
PubMed 32415788Teulieres M, Berard E, Marot V, Reina N, Ferre F, Minville V, Cavaignac E. A quadruple peripheral nerve block outside the OR for anterior cruciate ligament reconstruction reduces the OR occupancy time. Knee Surg Sports Traumatol Arthrosc. 2023 Jul;31(7):2917-2926. doi: 10.1007/s00167-022-07246-2. Epub 2022 Dec 5.
PubMed 36469051
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Fiberoptic Outer Diameters on Fiberoptic Intubation
- ClinicalTrials.gov ID
- NCT06709118
- Acronym / sponsor ID
- KY-2024-172
- Conditions
- Intubation Times
- Keywords
- Intubation, Ffiberoptic, Perioperative, Sore throat, Success rate
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Qinye ShiUniversity, hospital or other
- Study start
- 10 Dec 2024 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 29 Nov 2024 (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.
Fiberoptic intubation is an important method for anesthesiologists to deal with difficult airways, but its operation is difficult and requires repeated practice. Fiberoptic intubation is performed in two steps. First, the anesthesiologist holds the bronchoscope and exposes the base of the tongue, the epiglottis, and the glottis successively according to the front camera of the bronchoscope. Through the glottis, the main trachea is exposed to the carina. This process is visual and the anesthesiologist can see the main tissue structure directly. Then, the endotracheal catheter enters the endotracheal along the bronchoscope, and the process of endotracheal catheter entry is not visual.
In clinical work, it was found that the tracheal catheter was easily blocked when it passed through the glottis, and it was necessary to adjust the position of the tracheal catheter for several times before the tracheal catheter could be sent into the tracheal tube, which was easy to cause throat injury in the process. At present, relevant studies are mainly focused on the first step of bronchoscopic intubation, how to quickly expose the glottis and complete the bronchoscopic guidance process. However, there is no clear mention of the situation of catatoning in the process of endotracheal catheter and how to solve the problem of catatoning.
Detailed description
According to the inclusion and exclusion criteria，collecting the data of participants who undergone fiberoptic intubation. The observer analysis the safety and efficiency of fiberoptic intubation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3.8mm Group | – | Device: fiberopticOrotracheal intubation was performed with a 3.8 millimeter outer diameter fiberoptic |
| 2.8 mm group | – | Device: fiberopticOrotracheal intubation was performed with a 2.8 millimeter outer diameter fiberoptic |
| 4.8mm group | – | Device: fiberopticOrotracheal intubation was performed with a 4.8 millimeter outer diameter fiberoptic |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients in need of oral tube intubation and general anesthesia in our hospital for elective surgery
Key inclusion criteria (3 listed)
- 1.American Society of Anesthesiologists 1~2
- 2.18-60 year
- 3.Adult patients requiring general anesthesia for orotracheal intubation
Key exclusion criteria (4 listed)
- Limited mouth opening
- limited movement of temporomandibular joint
- abnormal glottic anatomy
- polyps of vocal cords
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 |
|---|---|---|
| fiberopticTracheal intubation was performed with different outer diameters of fiberoptic. | Device | 2.8 mm group, 3.8mm Group, 4.8mm group |
Primary outcome
Fiberoptic intubation attempts
Time frame: during the procedure
This is used to observe the passage of the tracheal tube through the glottis
First intubation success rate
Time frame: during the procedure
The incidence of tracheal tube through the vocal cords
Fiberoptic intubation time
Time frame: during the procedure
The duration of the intubation process
Time of passage of tracheal intubation through glottis
Time frame: during the procedure
The time the tracheal tube enters the trachea
2 secondary outcomes
Hoarseness after surgery
Time frame: 24 hours after surgery
Sore throat
Time frame: 24 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Background: PubMed 29028928Piegeler T, Clausen NG, Weiss M. Effectiveness of tip rotation in fibreoptic bronchoscopy under different experimental conditions: an in vitro crossover study. Br J Anaesth. 2017 Dec 1;119(6):1206-1212. doi: 10.1093/bja/aex322.
- Background: PubMed 32415788Karmali S, Rose P. Tracheal tube size in adults undergoing elective surgery - a narrative review. Anaesthesia. 2020 Nov;75(11):1529-1539. doi: 10.1111/anae.15041. Epub 2020 May 16.
- Background: PubMed 36469051Teulieres M, Berard E, Marot V, Reina N, Ferre F, Minville V, Cavaignac E. A quadruple peripheral nerve block outside the OR for anterior cruciate ligament reconstruction reduces the OR occupancy time. Knee Surg Sports Traumatol Arthrosc. 2023 Jul;31(7):2917-2926. doi: 10.1007/s00167-022-07246-2. Epub 2022 Dec 5.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Intubation Times, run by Qinye Shi.
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 3 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: opening soon, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact qinye shi doctor, MD (8618367915826, 980276903@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fiberoptic intubation attempts (time frame: during the procedure). The study lists 4 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 NCT06709118, which also lists 3 linked publications.
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 29 Nov 2024.