Cervical DisorderTCAFAVLTICSNCT03734965
The Comparison of Awake Fiberoptic And Awake Video Laryngoscopy Tracheal Intubation in Cervical Surgery
A study testing AWAKEN INTUBATION in people with Cervical Disorder, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
Intubation processes of patients under general anesthesia are important in terms of patient morbidity and mortality. The cervical region has also anatomical and physiologic speciality in which stability of the general condition of the patient during this intubation process. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cervical Disorder
- What is being tested?
- AWAKEN INTUBATION
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2018to 15 Oct 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years who planning cervical surgery
Who cannot join
- Patients with motor and sensory loss,
- Congenital neurological deficits, those with fiberoptic intubation inconveniences (with cerebrovascular case and hypertension),
- Patients with awake intubation (neuropsychiatric patients with orientation and cooperativeness impairment),
- Cardiovascular patients with local anesthetic allergy,
- Patients with difficult intubation history,
- Cervical surgery,
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- Body mass index> 30 kg / m2,
- Mallampati score III-IV,
- Thyromental distance> 6 cm,
- Risk of gastric aspiration and pregnancies will be excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Trakya University
Edirne, Centrum, 22030
Fatih Sağ, resident, +90-284-235-76-41, sag.fatih@gmail.com
Sevtap Hekimoğlu Şahin, Professor, sevtaphekimoglu@mynet.com
About this study
Official title: The Comparison of Awake Fiberoptic And Awake Video Laryngoscopy Tracheal
Intubation processes of patients under general anesthesia are important in terms of patient morbidity and mortality. The cervical region has also anatomical and physiologic speciality in which stability of the general condition of the patient during this intubation process. The cervical region needs to be manipulated very carefully due to respiratory center, cardiovascular balance and neurological integrity. During general anesthesia, the patient will be under the effect of muscle relaxant and especially the cervical region becomes vulnerable to trauma. The intubations made by affecting the cervical region as little as possible change the morbidity and mortality. Intubation with fiberoptic bronchoscopy and videolaryngoscopy has reduced the complications that other methods can cause. Awake intubation with fiberoptic bronchoscopy and videolaryngoscopy is important for neurological evaluation during the procedure. In this study, we aimed to compare awake intubation by videolaringoscopy and fiberotic bronchoscopy in patients with intubation difficulties due to restriction of neck movements in cervical surgery.
Read the detailed description
INTRODUCTION: Intubation processes of patients under general anesthesia are important in terms of patient morbidity and mortality. The cervical region has also anatomical and physiologic speciality in which stability of the general condition of the patient during this intubation process. The cervical region needs to be manipulated very carefully due to respiratory center, cardiovascular balance and neurological integrity. During general anesthesia, the patient will be under the effect of muscle relaxant and especially the cervical region becomes vulnerable to trauma. The intubations made by affecting the cervical region as little as possible change the morbidity and mortality. Intubation with fiberoptic bronchoscopy and videolaryngoscopy has reduced the complications that other methods can cause. Awake intubation with fiberoptic bronchoscopy and videolaryngoscopy is important for neurological evaluation during the procedure. In this study, we aimed to compare awake intubation by videolaringoscopy and fiberotic bronchoscopy in patients with intubation difficulties due to restriction of neck movements in cervical surgery.
METHODS: Patients in the ASA I-II-III risk group, aged 18-80 years, who will undergo cervical surgery operation between 01.04.2018 and 01.04.2020 by the Brain and Neurosurgeon at Trakya University Medical Faculty Hospital will be included. Patients will be prospectively randomized into 2 groups; Group F (intubation with fiberoptic in awake patients), Group V (intubation with videolaringoscopy in awake patients). In successful intubations the time between the time of access to the criterion laryngoscope and the appearance of the vocal cord will be assumed to be 60 seconds. Complications during intubation (mucosal injury, tooth trauma, lip injury, hypoxia (SpO2 <95%) and esophageal intubation) will be recorded. After intubation, the presence of blood in the Endotracheal Tube (ETT) or sore throat, which is expressed by the patient after recovery, will also be recorded.
STATISTICAL METHODS: Student-T test or Mann Whitney U test will be applied among the groups. Ki-Kara test will be used to compare categorical data.
CONCLUSION: Evaluation of mortality and morbidity of the patients awake intubation with fiberoptic bronchoscopy and videolaryngoscopy for cervical trauma surgery.
- Conditions
- Cervical Disorder
- Being tested
- AWAKEN INTUBATION
- Keywords
- aweken intubation, fiberoptic, videolaryngoscopy
- Medical subject headings
- Uterine Cervical Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AWAKEN INTUBATIONDevice
Intubation
| Study group | Role | What they receive |
|---|---|---|
| AWAKEN INTUBATION FIBEROPTIC | Active comparator | awaken intubation Receives: Device: AWAKEN INTUBATION |
| AWAKEN INTUBATION VIDEOLARYNGOSCOPY | Experimental | awaken intubation Receives: Device: AWAKEN INTUBATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
awaken intubation
succesful intubation
Measured: It is 60 seconds for succesfully intubation on procedure from it is starting to completed tracheal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start1 Aug 2018
- Primary completion12 Aug 2021
- Study completion15 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical DisorderStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Sag, Trakya University
- Investigators
- Sevtap Hekimoglu Sahin, Proffesor, Principal investigator, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734965
- Sponsor's protocol ID
- TÜTF-BAEK 2018/90
- Acronym
- TCAFAVLTICS
- Status last verified
- Oct 2021
- First submitted
- 19 Oct 2018
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Awake Fiberoptic And Awake Video Laryngoscopy Tracheal
- ClinicalTrials.gov ID
- NCT03734965
- Acronym / sponsor ID
- TCAFAVLTICS / TÜTF-BAEK 2018/90
- Conditions
- Cervical Disorder
- Keywords
- aweken intubation, fiberoptic, videolaryngoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 12 Aug 2021 (actual)
- Study completion
- 15 Oct 2021 (estimated)
- First posted
- 8 Nov 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.
Intubation processes of patients under general anesthesia are important in terms of patient morbidity and mortality. The cervical region has also anatomical and physiologic speciality in which stability of the general condition of the patient during this intubation process. The cervical region needs to be manipulated very carefully due to respiratory center, cardiovascular balance and neurological integrity. During general anesthesia, the patient will be under the effect of muscle relaxant and especially the cervical region becomes vulnerable to trauma. The intubations made by affecting the cervical region as little as possible change the morbidity and mortality. Intubation with fiberoptic bronchoscopy and videolaryngoscopy has reduced the complications that other methods can cause. Awake intubation with fiberoptic bronchoscopy and videolaryngoscopy is important for neurological evaluation during the procedure. In this study, we aimed to compare awake intubation by videolaringoscopy and fiberotic bronchoscopy in patients with intubation difficulties due to restriction of neck movements in cervical surgery.
Detailed description
INTRODUCTION: Intubation processes of patients under general anesthesia are important in terms of patient morbidity and mortality. The cervical region has also anatomical and physiologic speciality in which stability of the general condition of the patient during this intubation process. The cervical region needs to be manipulated very carefully due to respiratory center, cardiovascular balance and neurological integrity. During general anesthesia, the patient will be under the effect of muscle relaxant and especially the cervical region becomes vulnerable to trauma. The intubations made by affecting the cervical region as little as possible change the morbidity and mortality. Intubation with fiberoptic bronchoscopy and videolaryngoscopy has reduced the complications that other methods can cause. Awake intubation with fiberoptic bronchoscopy and videolaryngoscopy is important for neurological evaluation during the procedure. In this study, we aimed to compare awake intubation by videolaringoscopy and fiberotic bronchoscopy in patients with intubation difficulties due to restriction of neck movements in cervical surgery.
METHODS: Patients in the ASA I-II-III risk group, aged 18-80 years, who will undergo cervical surgery operation between 01.04.2018 and 01.04.2020 by the Brain and Neurosurgeon at Trakya University Medical Faculty Hospital will be included. Patients will be prospectively randomized into 2 groups; Group F (intubation with fiberoptic in awake patients), Group V (intubation with videolaringoscopy in awake patients). In successful intubations the time between the time of access to the criterion laryngoscope and the appearance of the vocal cord will be assumed to be 60 seconds. Complications during intubation (mucosal injury, tooth trauma, lip injury, hypoxia (SpO2 <95%) and esophageal intubation) will be recorded. After intubation, the presence of blood in the Endotracheal Tube (ETT) or sore throat, which is expressed by the patient after recovery, will also be recorded.
STATISTICAL METHODS: Student-T test or Mann Whitney U test will be applied among the groups. Ki-Kara test will be used to compare categorical data.
CONCLUSION: Evaluation of mortality and morbidity of the patients awake intubation with fiberoptic bronchoscopy and videolaryngoscopy for cervical trauma surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AWAKEN INTUBATION FIBEROPTIC | Active comparator | Device: AWAKEN INTUBATIONawaken intubation |
| AWAKEN INTUBATION VIDEOLARYNGOSCOPY | Experimental | Device: AWAKEN INTUBATIONawaken intubation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-80 years who planning cervical surgery
Key exclusion criteria (10 listed)
- Patients with motor and sensory loss,
- Congenital neurological deficits, those with fiberoptic intubation inconveniences (with cerebrovascular case and hypertension),
- Patients with awake intubation (neuropsychiatric patients with orientation and cooperativeness impairment),
- Cardiovascular patients with local anesthetic allergy,
- Patients with difficult intubation history,
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 |
|---|---|---|
| AWAKEN INTUBATIONIntubation | Device | AWAKEN INTUBATION FIBEROPTIC, AWAKEN INTUBATION VIDEOLARYNGOSCOPY |
Primary outcome
awaken intubation
Time frame: It is 60 seconds for succesfully intubation on procedure from it is starting to completed tracheal intubation
succesful intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- 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. This study is not recruiting at the moment.
Sevtap Hekimoglu Sahin, Proffesor principal investigator
Trakya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AWAKEN INTUBATION in people with Cervical Disorder, run by Trakya University at 1 site in Turkey (Türkiye).
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 10 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: status not confirmed, as of the sponsor's last update on 15 Oct 2021. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatih Sağ, resident (+90-284-235-76-41, sag.fatih@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
awaken intubation (time frame: It is 60 seconds for succesfully intubation on procedure from it is starting to completed tracheal 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 15 Oct 2021.