Awake Endotracheal Intubation in Cervical Injury

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;

Study Overview

• Status: Not yet recruiting
• Conditions: Trauma; Patient Satisfaction; Airway Morbidity
• Intervention / Treatment: Drug: sedative; Device: Awake endotracheal intubation by Glidescope videolaryngoscope; Device: Awake endotracheal intubation by Fiberoptic bronchoscope

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: November 9, 2022
• First Submitted That Met QC Criteria: November 9, 2022
• First Posted (Actual): November 17, 2022

Study Record Updates

• Last Update Posted (Actual): December 2, 2022
• Last Update Submitted That Met QC Criteria: November 30, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Hypnotics and Sedatives
• Other Study ID Numbers: 35636/8/22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No