Awake Endotracheal Intubation in Cervical Injury

Not Applicable

Not yet recruiting

• Conditions: Trauma; Airway Morbidity; Patient Satisfaction
• Interventions: Drug: sedative; Device: Awake endotracheal intubation by Glidescope videolaryngoscope; Device: Awake endotracheal intubation by Fiberoptic bronchoscope

• Registration Number: NCT05619965
• Lead Sponsor: Tanta University

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%.

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-09
• Study First Submitted QC: 2022-11-09
• Study First Posted: 2022-11-17
• Last Update Submitted: 2022-11-30
• Study Start: 2022-12-01
• Last Update Posted: 2022-12-02
• Primary Completion: 2023-04-01
• Study Completion: 2023-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Awake Glidoscope Videolaryngoscope	Awake endotracheal intubation by Glidescope videolaryngoscope	Awake endotracheal intubation of cervical trauma patients by Glidoscope Videolaryngoscope
Awake Fiberoptic bronchoscope	sedative	Awake endotracheal intubation of cervical trauma patients by Fiberoptic bronchoscope
Awake Glidoscope Videolaryngoscope	sedative	Awake endotracheal intubation of cervical trauma patients by Glidoscope Videolaryngoscope
Awake Fiberoptic bronchoscope	Awake endotracheal intubation by Fiberoptic bronchoscope	Awake endotracheal intubation of cervical trauma patients by Fiberoptic bronchoscope

Primary Outcome Measures

Name	Time	Method
intubating time	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	immediately post endotracheal intubation	intubating attempts per each patient (will be recorded by dedicated technician).

Secondary Outcome Measures

Name	Time	Method
patient satisfaction (score; excellent =1, good =2 and fair = 3).	immediately post endotracheal intubation	(score; excellent =1, good =2 and fair = 3).
heart rate	immediately post endotracheal intubation
mean arterial blood pressure	immediately post endotracheal intubation