Awake Endotracheal Intubation in Cervical Injury

NCT ID: NCT05619965

Last Updated: 2022-12-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2023-04-01

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%.

Conditions

Trauma; Patient Satisfaction; Airway Morbidity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Awake Glidoscope Videolaryngoscope

Awake endotracheal intubation of cervical trauma patients by Glidoscope Videolaryngoscope

Group Type: ACTIVE_COMPARATOR

sedative

Intervention Type: DRUG

dexmedetomidine 1 mic/kg IV over 10 minutes then 0.4 mic/kg/h continuous IV infusion

Awake endotracheal intubation by Glidescope videolaryngoscope

Intervention Type: DEVICE

Awake endotracheal intubation by Glidescope videolaryngoscope of cervical trauma patient

Awake Fiberoptic bronchoscope

Awake endotracheal intubation of cervical trauma patients by Fiberoptic bronchoscope

Group Type: ACTIVE_COMPARATOR

sedative

Intervention Type: DRUG

dexmedetomidine 1 mic/kg IV over 10 minutes then 0.4 mic/kg/h continuous IV infusion

Awake endotracheal intubation by Fiberoptic bronchoscope

Intervention Type: DEVICE

Awake endotracheal intubation by Fiberoptic bronchoscope of cervical trauma patient

Interventions

sedative

dexmedetomidine 1 mic/kg IV over 10 minutes then 0.4 mic/kg/h continuous IV infusion

Intervention Type: DRUG

Awake endotracheal intubation by Glidescope videolaryngoscope

Awake endotracheal intubation by Glidescope videolaryngoscope of cervical trauma patient

Intervention Type: DEVICE

Awake endotracheal intubation by Fiberoptic bronchoscope

Awake endotracheal intubation by Fiberoptic bronchoscope of cervical trauma patient

Intervention Type: DEVICE

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 .

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Mona Mohamed Mogahed

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

35636/8/22

Identifier Type: -

Identifier Source: org_study_id