TraumaNCT05619965
Awake Endotracheal Intubation in Cervical Injury
A study testing sedative, Awake endotracheal intubation by Glidescope videolaryngoscope and Awake endotracheal intubation by Fiberoptic bronchoscope in people with Trauma and Patient Satisfaction, run by Tanta University.
Trial summary
The researcher will compare awake endotracheal intubation with glidescope video assisted laryngoscope vs fiberoptic bronchoscope in patients with traumatic cervical injury; Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Trauma, Patient Satisfaction, Airway Morbidity
- What is being tested?
- sedative, Awake endotracheal intubation by Glidescope videolaryngoscope and Awake endotracheal intubation by Fiberoptic bronchoscope
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 1 Apr 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II patients
- ages 26-44
- undergoing a selective cervical spine fixation.
Who cannot join
- body mass index (BMI) more than 35 kg/m2.
- Obstructive airway disease
- cardiovascular disease
- apparent airway difficulty
- patient refusal .
About this study
Official title: Awake Endotracheal Intubation With Glidescope Video Assisted Laryngoscope vs Fiberoptic Bronchoscope in Patients With Traumatic Cervical Injury; Randomized Controlled Trial
The researcher will compare awake endotracheal intubation with glidescope video assisted laryngoscope vs fiberoptic bronchoscope in patients with traumatic cervical injury;
Read the detailed description
One hundred patients undergoing post traumatic cervical spine fixation under general anesthesia will be randomly allocated to two groups in a prospective study. Between December 2022 and May 2023.
All patients will be premedicated before the procedure and after giving 500 ml of lactated ringer solution with glycopyrrolate 0.2 mg iv and dexmedetomidine 1 mic/kg IV over 10 minutes then 0.4 mic/kg/h continuous IV infusion. All patients will receive standard clinical care monitoring including three lead ECG, noninvasive arterial blood pressure measurement and pulse oximeter. Patient will be administered oxygen 6 L/min through nasal prong.
Patients will be allocated into two equal groups (50 patients per group) for awake intubation with either FOB (F group) or GVL (G group) according to computer generated randomization technique. Each patient will receive nebulization with 5 ml of lidocaine 1% for 5 min followed by topicalization of soft palate and fauces with 5 puffs of lidocaine spray (10 mg/spray) immediately before the technique of endotracheal intubation (ID 6.5 mm for female and 7 mm in male, armored tube. Before airway manipulation each patient will receive a bolus dose of fentanil 1 mic/kg.
During the procedure Philadelphia cervical collar will be removed and MILS of cervical spine will be carried out by trained assistant (senior registrar anesthetist, 5 years' experience). After successful intubation (by consultant anesthesia who had more than 100 times successful intubation with either FOB or GVL) and neurological assessment (by spinal surgeon), general anesthesia will be induced with propofol 1.5 mg/kg, cisatracurium 0.1 mg/kg and remifentanil 0.5 lg/kg. Hypotension (decreased in MAPP 20% of base line) will be treated with ephedrine bolus 5-10 mg and 250 ml of lactated ringer solution. Only three attempts will be permitted per each patient and if failed plan B was to carry out endotracheal intubation under inhalational induction with FOB without neuromuscular blockade and to exclude patients from the study. Attempt will be held if O2 saturation decreased below 90%.
- Conditions
- Trauma, Patient Satisfaction, Airway Morbidity
- Being tested
- sedative, Awake endotracheal intubation by Glidescope videolaryngoscope, Awake endotracheal intubation by Fiberoptic bronchoscope
- Medical subject headings
- Wounds and Injuries, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sedativeDrug
dexmedetomidine 1 mic/kg IV over 10 minutes then 0.4 mic/kg/h continuous IV infusion
Awake endotracheal intubation by Glidescope videolaryngoscopeDevice
Awake endotracheal intubation by Glidescope videolaryngoscope of cervical trauma patient
Awake endotracheal intubation by Fiberoptic bronchoscopeDevice
Awake endotracheal intubation by Fiberoptic bronchoscope of cervical trauma patient
| Study group | Role | What they receive |
|---|---|---|
| Awake Glidoscope Videolaryngoscope | Active comparator | Awake endotracheal intubation of cervical trauma patients by Glidoscope Videolaryngoscope Receives: Drug: sedative; Device: Awake endotracheal intubation by Glidescope videolaryngoscope |
| Awake Fiberoptic bronchoscope | Active comparator | Awake endotracheal intubation of cervical trauma patients by Fiberoptic bronchoscope Receives: Drug: sedative; Device: Awake endotracheal intubation by Fiberoptic bronchoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
intubating time
(defined as the time from introduction of the scope till confirmation of correct endotracheal tube placement with three waves endtidal capnography)
Measured: immediately post endotracheal intubation
intubating attempts
intubating attempts per each patient (will be recorded by dedicated technician).
Measured: immediately post endotracheal intubation
Secondary outcomes (3)
heart rate
Measured: immediately post endotracheal intubation
mean arterial blood pressure
Measured: immediately post endotracheal intubation
patient satisfaction (score; excellent =1, good =2 and fair = 3).
(score; excellent =1, good =2 and fair = 3).
Measured: immediately post endotracheal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators will compare awake endotracheal intubation with glidescope video assisted laryngoscope vs fiberoptic bronchoscope in patients with traumatic cervical injury
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Mohamed Mogahed, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619965
- Sponsor's protocol ID
- 35636/8/22
- Status last verified
- Nov 2022
- First submitted
- 9 Nov 2022
- Last updated
- 2 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Awake Endotracheal Intubation With Glidescope Video Assisted Laryngoscope vs Fiberoptic Bronchoscope in Patients With Traumatic Cervical Injury; Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05619965
- Acronym / sponsor ID
- 35636/8/22
- Conditions
- Trauma, Patient Satisfaction, Airway Morbidity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 17 Nov 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.
The researcher will compare awake endotracheal intubation with glidescope video assisted laryngoscope vs fiberoptic bronchoscope in patients with traumatic cervical injury;
Detailed description
One hundred patients undergoing post traumatic cervical spine fixation under general anesthesia will be randomly allocated to two groups in a prospective study. Between December 2022 and May 2023.
All patients will be premedicated before the procedure and after giving 500 ml of lactated ringer solution with glycopyrrolate 0.2 mg iv and dexmedetomidine 1 mic/kg IV over 10 minutes then 0.4 mic/kg/h continuous IV infusion. All patients will receive standard clinical care monitoring including three lead ECG, noninvasive arterial blood pressure measurement and pulse oximeter. Patient will be administered oxygen 6 L/min through nasal prong.
Patients will be allocated into two equal groups (50 patients per group) for awake intubation with either FOB (F group) or GVL (G group) according to computer generated randomization technique. Each patient will receive nebulization with 5 ml of lidocaine 1% for 5 min followed by topicalization of soft palate and fauces with 5 puffs of lidocaine spray (10 mg/spray) immediately before the technique of endotracheal intubation (ID 6.5 mm for female and 7 mm in male, armored tube. Before airway manipulation each patient will receive a bolus dose of fentanil 1 mic/kg.
During the procedure Philadelphia cervical collar will be removed and MILS of cervical spine will be carried out by trained assistant (senior registrar anesthetist, 5 years' experience). After successful intubation (by consultant anesthesia who had more than 100 times successful intubation with either FOB or GVL) and neurological assessment (by spinal surgeon), general anesthesia will be induced with propofol 1.5 mg/kg, cisatracurium 0.1 mg/kg and remifentanil 0.5 lg/kg. Hypotension (decreased in MAPP 20% of base line) will be treated with ephedrine bolus 5-10 mg and 250 ml of lactated ringer solution. Only three attempts will be permitted per each patient and if failed plan B was to carry out endotracheal intubation under inhalational induction with FOB without neuromuscular blockade and to exclude patients from the study. Attempt will be held if O2 saturation decreased below 90%.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators will compare awake endotracheal intubation with glidescope video assisted laryngoscope vs fiberoptic bronchoscope in patients with traumatic cervical injury
| Arm | Type | Receives |
|---|---|---|
| Awake Glidoscope Videolaryngoscope | Active comparator | Drug: sedative, Device: Awake endotracheal intubation by Glidescope videolaryngoscopeAwake endotracheal intubation of cervical trauma patients by Glidoscope Videolaryngoscope |
| Awake Fiberoptic bronchoscope | Active comparator | Drug: sedative, Device: Awake endotracheal intubation by Fiberoptic bronchoscopeAwake endotracheal intubation of cervical trauma patients by Fiberoptic bronchoscope |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I-II patients
- ages 26-44
- undergoing a selective cervical spine fixation.
Key exclusion criteria (5 listed)
- body mass index (BMI) more than 35 kg/m2.
- Obstructive airway disease
- cardiovascular disease
- apparent airway difficulty
- patient refusal .
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 |
|---|---|---|
| sedativedexmedetomidine 1 mic/kg IV over 10 minutes then 0.4 mic/kg/h continuous IV infusion | Drug | Awake Fiberoptic bronchoscope, Awake Glidoscope Videolaryngoscope |
| Awake endotracheal intubation by Glidescope videolaryngoscopeAwake endotracheal intubation by Glidescope videolaryngoscope of cervical trauma patient | Device | Awake Glidoscope Videolaryngoscope |
| Awake endotracheal intubation by Fiberoptic bronchoscopeAwake endotracheal intubation by Fiberoptic bronchoscope of cervical trauma patient | Device | Awake Fiberoptic bronchoscope |
Primary outcome
intubating time
Time frame: immediately post endotracheal intubation
(defined as the time from introduction of the scope till confirmation of correct endotracheal tube placement with three waves endtidal capnography)
intubating attempts
Time frame: immediately post endotracheal intubation
intubating attempts per each patient (will be recorded by dedicated technician).
3 secondary outcomes
heart rate
Time frame: immediately post endotracheal intubation
mean arterial blood pressure
Time frame: immediately post endotracheal intubation
patient satisfaction (score; excellent =1, good =2 and fair = 3).
Time frame: immediately post endotracheal intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing sedative, Awake endotracheal intubation by Glidescope videolaryngoscope and Awake endotracheal intubation by Fiberoptic bronchoscope in people with Trauma and Patient Satisfaction, run by Tanta University.
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 5 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 2 Dec 2022. 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?
Results are not available in the source record.
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?
intubating time (time frame: immediately post endotracheal intubation). The study lists 2 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 2 Dec 2022.