Clinical trial NCT05619965: Awake Endotracheal Intubation in Cervical Injury
Official title: Awake Endotracheal Intubation With Glidescope Video Assisted Laryngoscope vs Fiberoptic Bronchoscope in Patients With Traumatic Cervical Injury; Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trauma
Patient Satisfaction
Airway Morbidity
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-11-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will compare awake endotracheal intubation with glidescope video assisted laryngoscope vs fiberoptic bronchoscope in patients with traumatic cervical injury
Primary purpose: OTHER

Brief summary: 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%.

Eligibility criteria: 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 .

Primary outcomes:
measure: intubating time
timeFrame: immediately post endotracheal intubation
measure: intubating attempts
timeFrame: immediately post endotracheal intubation
Secondary outcomes:
measure: heart rate
timeFrame: immediately post endotracheal intubation
measure: mean arterial blood pressure
timeFrame: immediately post endotracheal intubation
measure: patient satisfaction (score; excellent =1, good =2 and fair = 3).
timeFrame: immediately post endotracheal intubation
Other outcomes:
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