Intubation, IntratrachealNCT03759561
Tracheal Intubation Using Videolaryngoscope vs Fiberoptic Bronchoscope in Patients With Cervical Immobilization
A study testing intubation with videolaryngoscope vs fiberoptic bronchoscope in people with Intubation, Intratracheal, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
In patients with suspected cervical spine injury, cervical immobilization, such as manual in-line stabilization or cervical collar has been adopted to prevent further neurologic injury due to cervical motion. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Intubation, Intratracheal
- What is being tested?
- intubation with videolaryngoscope vs fiberoptic bronchoscope
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Dec 2018to 18 Jan 2022
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who require tracheal intubation
- Adult patients aged 20-80
- American Society of anesthesiologists physical status classification Ⅰ-Ⅲ
Who cannot join
- patient's refusal
- patients had a high risk of aspiration, history of gastroesophageal reflux disease, coagulopathy, previous history of radiation therapy on the neck and airway surgery, and upper airway lesions (i.e., tumor, polyp, inflammation, trauma, abscess, and foreign body)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Trial on Comparison of Tracheal Intubation Using Videolaryngoscope Versus Fiberoptic Bronchoscope in Patients Undergoing Cervical Spine Surgery
In patients with suspected cervical spine injury, cervical immobilization, such as manual in-line stabilization or cervical collar has been adopted to prevent further neurologic injury due to cervical motion. In these patients, tracheal intubation with direct laryngoscopy is often challenging due to limited mouth opening, neck flexion, and head extension. In this situation, videolaryngoscope and fiberoptic bronchoscope have been used for tracheal intubation in such patients. In this study, the initial success rate of tracheal intubation and intubation time between the videolaryngoscope and fiberoptic bronchoscope will be compared.
Read the detailed description
Patients entered the operating room without premedication. Airway-related parameters (modified Mallampati score, interincisior gap, thyromental distance, sternomental distance, and retrognathia) were evaluated in the sitting position. After changing to the supine position, thyromental height was measured and patients were monitored with electrocardiography, pulse oximetry, non-invasive blood pressure measurement, and processed electroencephalography. Cotton towels were placed below the patient's head for horizontal alignment of the external auditory meatus and the suprasternal notch. After sufficient preoxygenation for > 3 min, total intravenous anaesthesia was induced using a target-controlled infusion of propofol and remifentanil (effect site concentration: 4 µg/mL for propofol and 4 ng/mL for remifentanil). After confirming loss of consciousness, rocuronium (0.6-0.8 mg/kg) was administered to facilitate tracheal intubation, and mask ventilation was conducted. During mask ventilation, its difficulty was assessed and the use of the oropharyngeal airway was recorded. For invasive blood pressure measurement, a 20-gauge catheter was placed on the patient's radial artery. Thereafter, the patient's head was placed in the neutral position and an cervical collar was applied to minimise neck movement during intubation.
About 90 s after administrating rocuronium, tracheal intubation was attempted by one of five attending anaesthesiologists with a collective history of more than 30 successful videolaryngoscopic and fiberscopic intubations. A reinforced tracheal tube was used in both groups. Orotracheal intubation was performed using a videolaryngoscope with a disposable Macintosh-typed blade and a malleable stylet in the videolaryngoscope group, and using a flexible fiberscope with an eyepiece in the fiberscope group. A tracheal tube was mounted on the stylet and flexible fiberscope in the videolaryngoscope and fiberscope groups, respectively. The stylet was angulated about 60° at the proximal margin of the cuff. Tracheal intubation was initially attempted without any assistance, including airway manoeuvres and devices. If additional airway manoeuvres including external laryngeal manipulation (ELM), jaw thrust, and tongue traction were required during intubation attempts, they were performed by an assistant and noted. After confirming the glottis, the percentage of glottic opening (POGO) score was recorded just before inserting the tracheal tube into the trachea. The tracheal tube was inserted into the trachea after removing the stylet and confirming the carina in the videolaryngoscope and fiberscope groups, respectively. Successful intubation was confirmed by waveform capnography. The time from oral insertion of the intubation device to obtainment of the glottis view (glottis visualisation time), to placement of the tracheal tube (tube placement time), and to detection of the waveform capnograph (capnograph detection time) were also measured.
A maximum of three intubation attempts were allowed for the same anaesthesiologist, with a 180-s time limit for each attempt. If the peripheral oxygen saturation (SpO2) decreased to below 90% during the intubation attempt, the attempt was considered to have failed, and rescue mask ventilation was conducted until SpO2 reached 100%. Cases where tracheal intubation was unsuccessful on all three attempts were recorded as intubation failure.
After surgery, intubation-related airway complications were investigated. Airway injuries (blood in the oral cavity, blood staining on the tracheal tube, gum bleeding, and dental trauma) were assessed at the end of surgery. In addition, hoarseness and sore throat were evaluated at 1 h and 24 h after surgery. The severity of sore throat was measured using a numeric rating scale (NRS; 0: no pain, 10: worst pain imaginable).
Mean blood pressure (MBP), heart rate (HR), SpO2, and bispectral index (BIS) were recorded just before the intubation attempt and at 1 min after successful intubation. Other perioperative data (demographic, anaesthetic, and surgical data) were collected from electronic medical records.
- Conditions
- Intubation, Intratracheal
- Being tested
- intubation with videolaryngoscope vs fiberoptic bronchoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intubation with videolaryngoscope vs fiberoptic bronchoscopeProcedure or surgery
Tracheal intubation was performed using either videolaryngoscope or fiberoptic bronchoscope under cervical collar application according to the group allocations
| Study group | Role | What they receive |
|---|---|---|
| Videolaryngoscope group | Active comparator | In the videolaryngoscope group, tracheal intubation was performed using videolaryngoscope under cervical collar application. Receives: Procedure: intubation with videolaryngoscope vs fiberoptic bronchoscope |
| Fiberoptic bronchoscope group | Active comparator | In the fiberoptic bronchoscope group, tracheal intubation was performed using fiberoptic bronchoscope via oral cavity under cervical collar application. Receives: Procedure: intubation with videolaryngoscope vs fiberoptic bronchoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
The initial success rate
The first-pass success was defined as successful tracheal intubation on a single attempt in all stages of tracheal intubation
Measured: intraoperatively
Secondary outcomes (2)
intubation time
Intubation time was defined as time interval between insertion of the device into the oral cavity and withdrawal of the device from the oral cavity.
Measured: intraoperatively
the incidence of complication
The complications after the procedure included blood in the oral cavity, blood staining on the endotracheal tube, sore throat, and hoarseness. Blood in the oral cavity and blood staining on the endotracheal tube will be evaluated intraoperatively. Sore throat and hoarseness will be evaluated at 1 hour and 24 hours after the surgery
Measured: intraoperatively to 1hour and 24 hours after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start14 Dec 2018
- Primary completion17 Jan 2022
- Study completion18 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation, IntratrachealStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hee-pyoung Park, MD,PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03759561
- Sponsor's protocol ID
- VL_FOB
- Status last verified
- Oct 2022
- First submitted
- 29 Nov 2018
- Last updated
- 20 Oct 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 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial on Comparison of Tracheal Intubation Using Videolaryngoscope Versus Fiberoptic Bronchoscope in Patients Undergoing Cervical Spine Surgery
- ClinicalTrials.gov ID
- NCT03759561
- Acronym / sponsor ID
- VL_FOB
- Conditions
- Intubation, Intratracheal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 14 Dec 2018 (actual)
- Primary completion
- 17 Jan 2022 (actual)
- Study completion
- 18 Jan 2022 (actual)
- First posted
- 30 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.
In patients with suspected cervical spine injury, cervical immobilization, such as manual in-line stabilization or cervical collar has been adopted to prevent further neurologic injury due to cervical motion. In these patients, tracheal intubation with direct laryngoscopy is often challenging due to limited mouth opening, neck flexion, and head extension. In this situation, videolaryngoscope and fiberoptic bronchoscope have been used for tracheal intubation in such patients. In this study, the initial success rate of tracheal intubation and intubation time between the videolaryngoscope and fiberoptic bronchoscope will be compared.
Detailed description
Patients entered the operating room without premedication. Airway-related parameters (modified Mallampati score, interincisior gap, thyromental distance, sternomental distance, and retrognathia) were evaluated in the sitting position. After changing to the supine position, thyromental height was measured and patients were monitored with electrocardiography, pulse oximetry, non-invasive blood pressure measurement, and processed electroencephalography. Cotton towels were placed below the patient's head for horizontal alignment of the external auditory meatus and the suprasternal notch. After sufficient preoxygenation for > 3 min, total intravenous anaesthesia was induced using a target-controlled infusion of propofol and remifentanil (effect site concentration: 4 µg/mL for propofol and 4 ng/mL for remifentanil). After confirming loss of consciousness, rocuronium (0.6-0.8 mg/kg) was administered to facilitate tracheal intubation, and mask ventilation was conducted. During mask ventilation, its difficulty was assessed and the use of the oropharyngeal airway was recorded. For invasive blood pressure measurement, a 20-gauge catheter was placed on the patient's radial artery. Thereafter, the patient's head was placed in the neutral position and an cervical collar was applied to minimise neck movement during intubation.
About 90 s after administrating rocuronium, tracheal intubation was attempted by one of five attending anaesthesiologists with a collective history of more than 30 successful videolaryngoscopic and fiberscopic intubations. A reinforced tracheal tube was used in both groups. Orotracheal intubation was performed using a videolaryngoscope with a disposable Macintosh-typed blade and a malleable stylet in the videolaryngoscope group, and using a flexible fiberscope with an eyepiece in the fiberscope group. A tracheal tube was mounted on the stylet and flexible fiberscope in the videolaryngoscope and fiberscope groups, respectively. The stylet was angulated about 60° at the proximal margin of the cuff. Tracheal intubation was initially attempted without any assistance, including airway manoeuvres and devices. If additional airway manoeuvres including external laryngeal manipulation (ELM), jaw thrust, and tongue traction were required during intubation attempts, they were performed by an assistant and noted. After confirming the glottis, the percentage of glottic opening (POGO) score was recorded just before inserting the tracheal tube into the trachea. The tracheal tube was inserted into the trachea after removing the stylet and confirming the carina in the videolaryngoscope and fiberscope groups, respectively. Successful intubation was confirmed by waveform capnography. The time from oral insertion of the intubation device to obtainment of the glottis view (glottis visualisation time), to placement of the tracheal tube (tube placement time), and to detection of the waveform capnograph (capnograph detection time) were also measured.
A maximum of three intubation attempts were allowed for the same anaesthesiologist, with a 180-s time limit for each attempt. If the peripheral oxygen saturation (SpO2) decreased to below 90% during the intubation attempt, the attempt was considered to have failed, and rescue mask ventilation was conducted until SpO2 reached 100%. Cases where tracheal intubation was unsuccessful on all three attempts were recorded as intubation failure.
After surgery, intubation-related airway complications were investigated. Airway injuries (blood in the oral cavity, blood staining on the tracheal tube, gum bleeding, and dental trauma) were assessed at the end of surgery. In addition, hoarseness and sore throat were evaluated at 1 h and 24 h after surgery. The severity of sore throat was measured using a numeric rating scale (NRS; 0: no pain, 10: worst pain imaginable).
Mean blood pressure (MBP), heart rate (HR), SpO2, and bispectral index (BIS) were recorded just before the intubation attempt and at 1 min after successful intubation. Other perioperative data (demographic, anaesthetic, and surgical data) were collected from electronic medical records.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Videolaryngoscope group | Active comparator | Procedure: intubation with videolaryngoscope vs fiberoptic bronchoscopeIn the videolaryngoscope group, tracheal intubation was performed using videolaryngoscope under cervical collar application. |
| Fiberoptic bronchoscope group | Active comparator | Procedure: intubation with videolaryngoscope vs fiberoptic bronchoscopeIn the fiberoptic bronchoscope group, tracheal intubation was performed using fiberoptic bronchoscope via oral cavity under cervical collar application. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who require tracheal intubation
- Adult patients aged 20-80
- American Society of anesthesiologists physical status classification Ⅰ-Ⅲ
Key exclusion criteria (2 listed)
- patient's refusal
- patients had a high risk of aspiration, history of gastroesophageal reflux disease, coagulopathy, previous history of radiation therapy on the neck and airway surgery, and upper airway lesions (i.e., tumor, polyp, inflammation, trauma, abscess, and foreign body)
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 |
|---|---|---|
| intubation with videolaryngoscope vs fiberoptic bronchoscopeTracheal intubation was performed using either videolaryngoscope or fiberoptic bronchoscope under cervical collar application according to the group allocations | Procedure or surgery | Fiberoptic bronchoscope group, Videolaryngoscope group |
Primary outcome
The initial success rate
Time frame: intraoperatively
The first-pass success was defined as successful tracheal intubation on a single attempt in all stages of tracheal intubation
2 secondary outcomes
intubation time
Time frame: intraoperatively
the incidence of complication
Time frame: intraoperatively to 1hour and 24 hours after the surgery
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 20 Oct 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.
Hee-pyoung Park, MD,PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intubation with videolaryngoscope vs fiberoptic bronchoscope in people with Intubation, Intratracheal, run by Seoul National University Hospital at 1 site in South Korea.
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 2 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 20 Oct 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 South Korea. 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 initial success rate (time frame: intraoperatively). 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 20 Oct 2022.