Awake Endotracheal Intubation in Cervical Injury

NCT05619965 | Unknown

• 1 other identifier: 35636/8/22
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Trauma; Patient Satisfaction; Airway Morbidity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• heart rate

  immediately post endotracheal intubation

• mean arterial blood pressure

  immediately post endotracheal intubation

• patient satisfaction (score; excellent =1, good =2 and fair = 3).

  immediately post endotracheal intubation

Study Arms (2)

Awake Glidoscope Videolaryngoscope

ACTIVE COMPARATOR

Awake endotracheal intubation of cervical trauma patients by Glidoscope Videolaryngoscope

Drug: sedative; Device: Awake endotracheal intubation by Glidescope videolaryngoscope

Awake Fiberoptic bronchoscope

ACTIVE COMPARATOR

Awake endotracheal intubation of cervical trauma patients by Fiberoptic bronchoscope

Drug: sedative; Device: Awake endotracheal intubation by Fiberoptic bronchoscope

Interventions

sedative DRUG

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

Awake Fiberoptic bronchoscope; Awake Glidoscope Videolaryngoscope

Awake endotracheal intubation by Glidescope videolaryngoscope DEVICE

Awake endotracheal intubation by Glidescope videolaryngoscope of cervical trauma patient

Awake Glidoscope Videolaryngoscope

Awake endotracheal intubation by Fiberoptic bronchoscope DEVICE

Awake endotracheal intubation by Fiberoptic bronchoscope of cervical trauma patient

Awake Fiberoptic bronchoscope

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-II patients
• ages 26-44
• undergoing a selective cervical spine fixation.

You may not qualify if:

• body mass index (BMI) more than 35 kg/m2.
• Obstructive airway disease
• cardiovascular disease
• apparent airway difficulty
• patient refusal .

Sponsors & Collaborators

• Tanta University: lead

MeSH Terms

Conditions

Wounds and Injuries; Patient Satisfaction

Interventions

Hypnotics and Sedatives

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

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

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 17, 2022
• Study Start: December 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: December 2, 2022

Record last verified: 2022-11