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Comparing a New Device for Submental Intubation in Patients with Midface Fractures Involving the Nose

Comparative Evaluation of Efficacy of a Novel Instrument for Submental Intubation with Nasal Speculum and Curved Artery Forcep in Midface Trauma involving the Nasal Bone- A Three Arm Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/10/096553
Enrollment
75
Registered
2025-10-29
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: Z768- Persons encountering health services in other specified circumstances

Interventions

Intervention1: submental intubation with artery forcep: a 1.5cm skin incision will be made in the paramedian region, approximately 1cm from the lower border of the mandible, taking care to avoid the f

Sponsors

Narsinhbhai Patel Dental College Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients indicated for open reduction and internal fixation for midface fractures having difficult nasal intubation. 2. Healthy patients falling under ASA I and ASA II classification 3. Subjects / guardian able and willing to provide written informed consent and compliant with study procedure

Exclusion criteria

Exclusion criteria: 1. Patients having maxillofacial trauma where nasal intubation can be done. 2. Patients who are already tracheostomized. 3. Patients where oral intubation is difficult and indicated for tracheostomy. 4. Patients with a history of coagulopathy. 5. Patient with laryngotracheal injuries. 6. Patient is a having active infection at the proposed site. 7. Gunshot wounds in that area. 8. Long-term airway management needs and 9. Patient with a history of keloid formation.

Design outcomes

Primary

MeasureTime frame
1. Procedure time 2. Intubation transition time 3. Apnea time 4. Hemodynamic changes 5. Surgeons’ satisfaction 6. Anesthetists satisfaction Timepoint: Day 0 that is baseline intraoperatively

Secondary

MeasureTime frame
• Scar assessment will be don on 7th day, 15th day and after one month. • Any other complication if it is happening during and after the procedure will be noted down. Timepoint: post operatively- 7th day , 15th day and one month

Countries

India

Contacts

Public ContactShallu Bansal

Narsinhbhai Patel Dental College and Hospital Visnagar Gujarat

amanagutti.fds@spu.ac.in09727756155

Outcome results

None listed

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