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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05619965
Enrollment
100
Registered
2022-11-17
Start date
2022-12-01
Completion date
2023-04-01
Last updated
2022-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trauma, Patient Satisfaction, Airway Morbidity

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%.

Interventions

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

DEVICEAwake endotracheal intubation by Glidescope videolaryngoscope

Awake endotracheal intubation by Glidescope videolaryngoscope of cervical trauma patient

DEVICEAwake endotracheal intubation by Fiberoptic bronchoscope

Awake endotracheal intubation by Fiberoptic bronchoscope of cervical trauma patient

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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 .

Design outcomes

Primary

MeasureTime frameDescription
intubating timeimmediately 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 attemptsimmediately post endotracheal intubationintubating attempts per each patient (will be recorded by dedicated technician).

Secondary

MeasureTime frameDescription
heart rateimmediately post endotracheal intubation
mean arterial blood pressureimmediately post endotracheal intubation
patient satisfaction (score; excellent =1, good =2 and fair = 3).immediately post endotracheal intubation(score; excellent =1, good =2 and fair = 3).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026