Awake Endotracheal Intubation in Cervical Injury

Study Overview
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Brief Summary
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The researcher will compare awake endotracheal intubation with glidescope video assisted laryngoscope vs fiberoptic bronchoscope in patients with traumatic cervical injury;

Detailed Description
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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%.

Official Title
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Awake Endotracheal Intubation With Glidescope Video Assisted Laryngoscope vs Fiberoptic Bronchoscope in Patients With Traumatic Cervical Injury; Randomized Controlled Trial

Conditions
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Trauma, Patient Satisfaction, Airway Morbidity

Intervention / Treatment
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* Drug: sedative
* Device: Awake endotracheal intubation by Glidescope videolaryngoscope
* Device: Awake endotracheal intubation by Fiberoptic bronchoscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I-II patients ages 26-44 undergoing a selective cervical spine fixation. Exclusion Criteria: body mass index (BMI) more than 35 kg/m2. Obstructive airway disease cardiovascular disease apparent airway difficulty patient refusal .

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Awake Glidoscope Videolaryngoscope<br>Awake endotracheal intubation of cervical trauma patients by Glidoscope Videolaryngoscope | Drug: sedative<br>* dexmedetomidine 1 mic/kg IV over 10 minutes then 0.4 mic/kg/h continuous IV infusion<br>Device: Awake endotracheal intubation by Glidescope videolaryngoscope<br>* Awake endotracheal intubation by Glidescope videolaryngoscope of cervical trauma patient<br>|
| Active Comparator: Awake Fiberoptic bronchoscope<br>Awake endotracheal intubation of cervical trauma patients by Fiberoptic bronchoscope | Drug: sedative<br>* dexmedetomidine 1 mic/kg IV over 10 minutes then 0.4 mic/kg/h continuous IV infusion<br>Device: Awake endotracheal intubation by Fiberoptic bronchoscope<br>* Awake endotracheal intubation by Fiberoptic bronchoscope of cervical trauma patient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intubating time | (defined as the time from introduction of the scope till confirmation of correct endotracheal tube placement with three waves endtidal capnography) | immediately post endotracheal intubation | 
| intubating attempts | intubating attempts per each patient (will be recorded by dedicated technician). | immediately post endotracheal intubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate |  | immediately post endotracheal intubation | 
| mean arterial blood pressure |  | immediately post endotracheal intubation | 
| patient satisfaction (score; excellent =1, good =2 and fair = 3). | (score; excellent =1, good =2 and fair = 3). | immediately post endotracheal intubation |