Intubation; Difficult or FailedNCT05243758
Who is Rapid And Success? The Comparison Of Video Fiberscope And Video Laryngoscope
A study testing Group video fiberscope of experienced practitioner, Group video laryngoscope of experienced practitioner and Group video fiberscope of less experienced practitioner in people with Intubation; Difficult or Failed and Airway Responsiveness, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
Endotracheal intubation plays an important role in general anesthesia. Complications can be prevented by using alternative airway devices in predetermined difficult intubation cases. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation; Difficult or Failed, Airway Responsiveness
- What is being tested?
- Group video fiberscope of experienced practitioner, Group video laryngoscope of experienced practitioner and Group video fiberscope of less experienced practitioner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2018to 1 Mar 2019
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Operated in the operating room of our hospital,
- Aged 18-65,
- EGRI score>4,
- ASA (American Society of Anesthesiologists) score<4
Who cannot join
- Cerebrovascular disease (cerebral ischemia, hemorrhage or stroke), presence of carotid stenosis or history of coronary artery disease,
- Neurological disorders (history of chronic headache, epilepsy or head trauma), alcohol or psychoactive drug addiction,
- Serious heart and/or lung diseases, liver and/or kidney failure,
- Uncontrolled diabetes and/or hypertension,
- Dental abscess,
- Mouth opening <1.5 cm,
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- Known bleeding disorder,
- Pregnancy,
- Mental retardation,
- Contraindications to drugs, allergy to drugs used,
- Patient rejection
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayis University Faculty of Medicine
Samsun, Atakum, 55200
About this study
Official title: The Comparison Of Video Fiberscope And Video Laryngoscope,With Egri Score> 4
Endotracheal intubation plays an important role in general anesthesia. Complications can be prevented by using alternative airway devices in predetermined difficult intubation cases. In this study, the investigators aimed to compare the results of endotracheal intubation with video fiberscope and DCI video laryngoscope devices of two different experienced physicians (E and H).
Read the detailed description
In this randomized and prospective study, 60 patients with EGRI score> 4 and ASA score <4, operated between 1 October 2018 and 1 March 2019 in Ondokuz Mayıs University Medical Faculty Hospital were included. Endotracheal intubation was performed by two practitioners using two different devices. Intubation times, number of attempts, failed attempts, postoperative complications and hemodynamic responses were recorded.
- Being tested
- Group video fiberscope of experienced practitioner, Group video laryngoscope of experienced practitioner, Group video fiberscope of less experienced practitioner, Group video laryngoscope of less experienced practitioner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group video fiberscope of experienced practitionerDevice
One of the classical alternatives to laryngoscopy in difficult endotracheal intubation is video laryngoscopyvideo fiberscope( Karl Storz GmbH \&Co. KG, Tuttlingen, Germany). Reaching the image from the patient with pre- and from the cervical point of view, or from the cervical point of view, to be completed with a good view from a large screen to be completed with an image before and within intubation. It also facilitates learning in education.
Group video laryngoscope of experienced practitionerDevice
Intubation Pending Difficult as well as challenging . Fiberoptic (fiberscope) intubation is the gold standard in difficult airway. Lacking this supplement, it will be widely used for practice, as it is suitable for video laryngeal.
Group video fiberscope of less experienced practitionerDevice
One of the classical alternatives to laryngoscopy in difficult endotracheal intubation is video laryngoscopy video fiberscope( Karl Storz GmbH \&Co. KG, Tuttlingen, Germany). Reaching the image from the patient with pre- and from the cervical point of view, or from the cervical point of view, to be completed with a good view from a large screen to be completed with an image before and within intubation. It also facilitates learning in education.
Group video laryngoscope of less experienced practitionerDevice
Entubation pending difficult as well as challenging . Fiberoptic (fiberscope) intubation is the gold standard in difficult airway. Lacking this supplement, it will be widely used for practice, as it is suitable for video laryngeal.Storz DCI Video Laryngoscope (Karl Storz GmbH \&Co. KG, Tuttlingen, Germany)
| Study group | Role | What they receive |
|---|---|---|
| Group video fiberscope of experienced practitioner | Active comparator | More experienced physician: endotracheal intubation with video fiberscope Assoc. Dr. The group in which Ersin Köksal performed endotracheal intubation using a video fiberscope( Karl Storz GmbH \&Co. KG, Tuttlingen, Germany) consisted of 15 patients.Endotracheal intubation was performed by two practitioners using two different devices. Intubation times, number of attempts, failed attempts, postoperative complications and hemodynamic responses were recorded. Receives: Device: Group video fiberscope of experienced practitioner; Device: Group video fiberscope of less experienced practitioner |
| Group video laryngoscope of experienced practitioner | Active comparator | More experienced physician: Endotracheal intubation with DCI video laryngoscopeThe group in which Assoc. Dr. Ersin Köksal performed endotracheal intubation using a DCI video laryngoscope(Storz DCI Video Laryngoscope (Karl Storz GmbH \&Co. KG, Tuttlingen, Germany) consisted of 15 patients.Endotracheal intubation was performed by two practitioners using two different devices. Intubation times, number of attempts, failed attempts, postoperative complications and hemodynamic responses were recorded. Receives: Device: Group video laryngoscope of experienced practitioner; Device: Group video laryngoscope of less experienced practitioner |
| Group video fiberscope of less experienced practitioner | Active comparator | Endotracheal intubation with video fiberscope: The group in which DrHalil Cebeci applied endotracheal intubation using a video fiberscope( Karl Storz GmbH \&Co. KG, Tuttlingen, Germany) consisted of 15 patients. Endotracheal intubation was performed by two practitioners using two different devices. Intubation times, number of attempts, failed attempts, postoperative complications and hemodynamic responses were recorded. Receives: Device: Group video fiberscope of experienced practitioner; Device: Group video fiberscope of less experienced practitioner |
| Group video laryngoscope of less experienced practitioner | Active comparator | Endotracheal intubation with DCI video laryngoscope:The group in which Dr.Halil Cebeci applied endotracheal intubation using a DCI video laryngoscope(Karl Storz GmbH \&Co. KG, Tuttlingen, Germany) consisted of 15 patients.Endotracheal intubation was performed by two practitioners using two different devices. Intubation times, number of attempts, failed attempts, postoperative complications and hemodynamic responses were recorded. Receives: Device: Group video laryngoscope of experienced practitioner; Device: Group video laryngoscope of less experienced practitioner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation times,
The moment when the endotracheal intubation tube was passed between the vocal cords following the vocal cord image obtained with the device was recorded in seconds. In endotracheal intubation performed with a video fiberscope, the end of the fiberscope with a camera passing through the vocal cords, and in endotracheal intubation performed with a DCI video laryngoscope, the intubation tube passing between the vocal cords was counted as successful intubation time.
Measured: during intubation
Number of attempts
The procedure will be considered unsuccessful if intubation is unsuccessful in three attempts, if the intubation process exceeds three minutes, or if the peripheral oxygen saturation (SpO2) is <90% during this period. If this situation was encountered, it was planned to ventilate the patient with an anesthesia mask until the oxygen saturation approached 100% and to use alternative airway devices.
Measured: during intubation for patients,
Time to find the glottis:
The time from the moment the device entered between the patient's anterior incisors until the vocal cords were seen was recorded in seconds.
Measured: during intubation for patients
Blood pressure
Hemodynamic parameters; heart rate (/min), systolic blood pressure (mmHg), diastolic blood pressure (mmHg), mean arterial pressure (mmHg), and SpO2 were recorded before induction (baseline), during intubation, at 1st, 2nd and 5th minutes after intubation
Measured: During intubation, at 1st, 2nd and 5th minutes after intubation
Pulse oximeter
Oximetry is a convenient and painless alternative to needlesticks, is simple to use, and provides immediate data. These advantages make oximetry an invaluable tool for determination the client's need for oxygen therapy and assessing effectiveness of therapy. The oximeter registers arterial oxygen saturation (SaO2). An SaO2 greater than 95% is considered normal, whereas values lower than 93% usually indicate the need for oxygen therapy and further assessment.
Measured: Before induction (baseline), during intubation, at 1st, 2nd and 5th minutes after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start1 Nov 2018
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation; Difficult or FailedStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 60 patients aged between 18-65 years, who were operated in the operating room of our hospital, with an EGRI score of \>4 and an ASA (American Society of Anesthesiologists) score of \<4 were included.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halil CEBECI, Ondokuz Mayıs University
- Investigators
- ERSIN KOKSAL, PROFFOSOR, Study director, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243758
- Sponsor's protocol ID
- B.30.2.ODM.0.20.08/1822
- Status last verified
- Nov 2018
- First submitted
- 5 Dec 2021
- Last updated
- 17 Feb 2022
- 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 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison Of Video Fiberscope And Video Laryngoscope,With Egri Score> 4
- ClinicalTrials.gov ID
- NCT05243758
- Acronym / sponsor ID
- B.30.2.ODM.0.20.08/1822
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 17 Feb 2022 (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.
Endotracheal intubation plays an important role in general anesthesia. Complications can be prevented by using alternative airway devices in predetermined difficult intubation cases. In this study, the investigators aimed to compare the results of endotracheal intubation with video fiberscope and DCI video laryngoscope devices of two different experienced physicians (E and H).
Detailed description
In this randomized and prospective study, 60 patients with EGRI score> 4 and ASA score <4, operated between 1 October 2018 and 1 March 2019 in Ondokuz Mayıs University Medical Faculty Hospital were included. Endotracheal intubation was performed by two practitioners using two different devices. Intubation times, number of attempts, failed attempts, postoperative complications and hemodynamic responses were recorded.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- 60 patients aged between 18-65 years, who were operated in the operating room of our hospital, with an EGRI score of >4 and an ASA (American Society of Anesthesiologists) score of <4 were included.
| Arm | Type | Receives |
|---|---|---|
| Group video fiberscope of experienced practitioner | Active comparator | Device: Group video fiberscope of experienced practitioner, Device: Group video fiberscope of less experienced practitionerMore experienced physician: endotracheal intubation with video fiberscope Assoc. Dr. The group in which Ersin Köksal performed endotracheal intubation using a video fiberscope( Karl Storz GmbH \&Co. KG, Tuttlingen, Germany) consisted of 15 patients.Endotracheal intubation was performed by two practitioners using two different devices. Intubation times, number of attempts, failed attempts, postoperative complications and hemodynamic responses were recorded. |
| Group video laryngoscope of experienced practitioner | Active comparator | Device: Group video laryngoscope of experienced practitioner, Device: Group video laryngoscope of less experienced practitionerMore experienced physician: Endotracheal intubation with DCI video laryngoscopeThe group in which Assoc. Dr. Ersin Köksal performed endotracheal intubation using a DCI video laryngoscope(Storz DCI Video Laryngoscope (Karl Storz GmbH \&Co. KG, Tuttlingen, Germany) consisted of 15 patients.Endotracheal intubation was performed by two practitioners using two different devices. Intubation times, number of attempts, failed attempts, postoperative complications and hemodynamic responses were recorded. |
| Group video fiberscope of less experienced practitioner | Active comparator | Device: Group video fiberscope of experienced practitioner, Device: Group video fiberscope of less experienced practitionerEndotracheal intubation with video fiberscope: The group in which DrHalil Cebeci applied endotracheal intubation using a video fiberscope( Karl Storz GmbH \&Co. KG, Tuttlingen, Germany) consisted of 15 patients. Endotracheal intubation was performed by two practitioners using two different devices. Intubation times, number of attempts, failed attempts, postoperative complications and hemodynamic responses were recorded. |
| Group video laryngoscope of less experienced practitioner | Active comparator | Device: Group video laryngoscope of experienced practitioner, Device: Group video laryngoscope of less experienced practitionerEndotracheal intubation with DCI video laryngoscope:The group in which Dr.Halil Cebeci applied endotracheal intubation using a DCI video laryngoscope(Karl Storz GmbH \&Co. KG, Tuttlingen, Germany) consisted of 15 patients.Endotracheal intubation was performed by two practitioners using two different devices. Intubation times, number of attempts, failed attempts, postoperative complications and hemodynamic responses were recorded. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Operated in the operating room of our hospital,
- Aged 18-65,
- EGRI score>4,
- ASA (American Society of Anesthesiologists) score<4
Key exclusion criteria (11 listed)
- Cerebrovascular disease (cerebral ischemia, hemorrhage or stroke), presence of carotid stenosis or history of coronary artery 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 |
|---|---|---|
| Group video fiberscope of experienced practitionerOne of the classical alternatives to laryngoscopy in difficult endotracheal intubation is video laryngoscopyvideo fiberscope( Karl Storz GmbH \&Co. KG, Tuttlingen, Germany). Reaching the image from the patient with pre- and from the cervical point of view, or from the cervical point of view, to be completed with a good view from a large screen to be completed with an image before and within intubation. It also facilitates learning in education. | Device | Group video fiberscope of experienced practitioner, Group video fiberscope of less experienced practitioner |
| Group video laryngoscope of experienced practitionerIntubation Pending Difficult as well as challenging . Fiberoptic (fiberscope) intubation is the gold standard in difficult airway. Lacking this supplement, it will be widely used for practice, as it is suitable for video laryngeal. | Device | Group video laryngoscope of experienced practitioner, Group video laryngoscope of less experienced practitioner |
| Group video fiberscope of less experienced practitionerOne of the classical alternatives to laryngoscopy in difficult endotracheal intubation is video laryngoscopy video fiberscope( Karl Storz GmbH \&Co. KG, Tuttlingen, Germany). Reaching the image from the patient with pre- and from the cervical point of view, or from the cervical point of view, to be completed with a good view from a large screen to be completed with an image before and within intubation. It also facilitates learning in education. | Device | Group video fiberscope of experienced practitioner, Group video fiberscope of less experienced practitioner |
| Group video laryngoscope of less experienced practitionerEntubation pending difficult as well as challenging . Fiberoptic (fiberscope) intubation is the gold standard in difficult airway. Lacking this supplement, it will be widely used for practice, as it is suitable for video laryngeal.Storz DCI Video Laryngoscope (Karl Storz GmbH \&Co. KG, Tuttlingen, Germany) | Device | Group video laryngoscope of experienced practitioner, Group video laryngoscope of less experienced practitioner |
Primary outcome
Intubation times,
Time frame: during intubation
The moment when the endotracheal intubation tube was passed between the vocal cords following the vocal cord image obtained with the device was recorded in seconds. In endotracheal intubation performed with a video fiberscope, the end of the fiberscope with a camera passing through the vocal cords, and in endotracheal intubation performed with a DCI video laryngoscope, the intubation tube passing between the vocal cords was counted as successful intubation time.
Number of attempts
Time frame: during intubation for patients,
The procedure will be considered unsuccessful if intubation is unsuccessful in three attempts, if the intubation process exceeds three minutes, or if the peripheral oxygen saturation (SpO2) is <90% during this period. If this situation was encountered, it was planned to ventilate the patient with an anesthesia mask until the oxygen saturation approached 100% and to use alternative airway devices.
Time to find the glottis:
Time frame: during intubation for patients
The time from the moment the device entered between the patient's anterior incisors until the vocal cords were seen was recorded in seconds.
Blood pressure
Time frame: During intubation, at 1st, 2nd and 5th minutes after intubation
Hemodynamic parameters; heart rate (/min), systolic blood pressure (mmHg), diastolic blood pressure (mmHg), mean arterial pressure (mmHg), and SpO2 were recorded before induction (baseline), during intubation, at 1st, 2nd and 5th minutes after intubation
Pulse oximeter
Time frame: Before induction (baseline), during intubation, at 1st, 2nd and 5th minutes after intubation
Oximetry is a convenient and painless alternative to needlesticks, is simple to use, and provides immediate data. These advantages make oximetry an invaluable tool for determination the client's need for oxygen therapy and assessing effectiveness of therapy. The oximeter registers arterial oxygen saturation (SaO2). An SaO2 greater than 95% is considered normal, whereas values lower than 93% usually indicate the need for oxygen therapy and further assessment.
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 17 Feb 2022.
- 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.
ERSIN KOKSAL, PROFFOSOR study director
Ondokuz Mayıs 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 Group video fiberscope of experienced practitioner, Group video laryngoscope of experienced practitioner and Group video fiberscope of less experienced practitioner in people with Intubation; Difficult or Failed and Airway Responsiveness, run by Ondokuz Mayıs 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 4 inclusion and 11 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 17 Feb 2022. 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?
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?
Intubation times, (time frame: during intubation). The study lists 5 primary outcomes in all. 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 17 Feb 2022.