Awake Endotracheal Intubation in Cervical Injury

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05619965
• Other study ID #: 35636/8/22
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: November 2022
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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%.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Airway Morbidity
• Patient Satisfaction
• Trauma

Intervention

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
• Awake endotracheal intubation by Fiberoptic bronchoscope
Awake endotracheal intubation by Fiberoptic bronchoscope of cervical trauma patient

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	intubating attempts	intubating attempts per each patient (will be recorded by dedicated technician).	immediately post endotracheal intubation
Secondary	heart rate		immediately post endotracheal intubation
Secondary	mean arterial blood pressure		immediately post endotracheal intubation
Secondary	patient satisfaction (score; excellent =1, good =2 and fair = 3).	(score; excellent =1, good =2 and fair = 3).	immediately post endotracheal intubation