A clinical trial to study the difference between fibre optic bronchoscope intubation and C Mac video laryngoscopic intubation in cervical spine injury patient under awake condition

Comparison between C-MAC video laryngoscope versus fibreoptic bronchoscope for awake intubation under ketofol-ketamine plus propofol sedation in cervical spine injury: immobilised with cervical collar: Prospective Randomized Controlled trial ? - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/065456

Enrollment

Registered

2024-04-09

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Health Condition 1: S129- Fracture of neck, unspecified Health Condition 2: O- Medical and Surgical Health Condition 3: S131- Subluxation and dislocation of cervical vertebrae Health Condition 4: S130- Traumatic rupture of cervical intervertebral disc

Interventions

Intervention1: Intubation using C-MAC video laryngoscope: C-MAC videolaryngoscope will be passed into the patients mouth over tongue in midline, distal end of C-MAC laryngoscope is positioned in valle

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA 1 and 2 patients 2. Patients above 18 years and less than 70 years 3. Patients with BMI less than 30 4. Patients undergoing elective surgeries 5. Patients with traumatic cervical spine injury with neck collar

Exclusion criteria

Exclusion criteria: 1. Patient who do not consent for study 2. Patients at risk of aspiration 3. Emergency surgeries 4. Patients with high risk for surgery like cardiac condition 5. Patients with local anaesthetic allergy 6. Patients with delirious symptoms, cognitive dysfunction 7. Patients with other cervical spine diseases

Design outcomes

Primary

Measure	Time frame
To compare the success of intubation in first attempt with C-MAC video laryngoscope versus fibreoptic bronchoscope for awake intubation under ketofol sedation in cervical spine injury: immobilised with cervical collarTimepoint: Time for successful intubation(T1+T2) T1- time for visualisation of glottis T2- from visualisation of glottis to confirmation of intubation by capnography	—

Secondary

Measure	Time frame
Ease of intubation by Likert scaleTimepoint: 1- extremely easy 2- easy 3- somewhat easy 4- not very easy 5- most difficult;Haemodynamic changesTimepoint: Heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, saturation at baseline, 5 minutes, 10 minutes before intubation, 0 minutes, 5 minutes, 10 minutes, 15 minutes after intubation;Ramsay sedation scoreTimepoint: 1- anxious and agitated or restless or both 2- cooperative, oriented and tranquil 3- responding to commands only 4- brisk response to loght glabellar tap or loud auditory stimulus 5- sluggish response to light glabellar tap or loud auditory stimulus 6- no response to stimulus	—

Measure

Time frame

Ease of intubation by Likert scaleTimepoint: 1- extremely easy 2- easy 3- somewhat easy 4- not very easy 5- most difficult;Haemodynamic changesTimepoint: Heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, saturation at baseline, 5 minutes, 10 minutes before intubation, 0 minutes, 5 minutes, 10 minutes, 15 minutes after intubation;Ramsay sedation scoreTimepoint: 1- anxious and agitated or restless or both 2- cooperative, oriented and tranquil 3- responding to commands only 4- brisk response to loght glabellar tap or loud auditory stimulus 5- sluggish response to light glabellar tap or loud auditory stimulus 6- no response to stimulus

—

Countries

India

Contacts

Public ContactDr Thalishetti Yugala

Nizams institute of medical sciences

sapnanikhar@gmail.com9030460262

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026