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Evaluation of Efficacy of Submental Intubation with Nasal Speculum in Midface Trauma- A Randomized Controlled Trial

A Clinical Evaluation of Nasal Speculum-Guided Submental Intubation in Midface Fracture Management: A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/087483
Enrollment
50
Registered
2025-05-23
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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: Nasal Speculum with artery forcep assisted Submental Intubation: Study Group 2 For submental intubation, a 1.5cm skin incision will be made in the paramedian region, approximately 1cm

Sponsors

Narsinhbhai Patel Dental College Hospital Visnagar Gujarat
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients between the ages of 18 to 70 years of both genders. 2. Patients indicated for open reduction and internal fixation for midface fractures who have difficult nasal intubation. 3. Healthy patients falling under ASA I and ASA II classification 4. Subjects/guardians are able and willing to provide written informed consent and are compliant with the study procedure.

Exclusion criteria

Exclusion criteria: 1. Patients having midface trauma where nasal intubation can be done. 2. Patients who are tracheostomized. 3. Patients for whom oral intubation is difficult and for whom tracheostomy is necessary. 4. Patients with a history of coagulopathy.

Design outcomes

Primary

MeasureTime frame
1) Procedure time in min: 2) Intubation Transition Time in min : 3) Hemodynamic changes: it includes measurement of BP, Pulse and Oxygen saturation and three intervals 1) before disconnection to circuit, after disconnection, and after reconnection to circuit) 4) Anesthetists Satisfaction: 5) Surgeons Satisfaction: Timepoint: Day 0

Secondary

MeasureTime frame
1) Scar Assessment: It will be done on the 7th, 15th, and after one month postoperatively, with scar assessment score given by Lieneke et al. 2) Any other complication that arises will be noticedTimepoint: 7th , 15th and one month post operatively

Countries

India

Contacts

Public ContactDr Shallu Bansal

Narsinhbhai Patel Dental College and Hospital Visnagar Gujarat

amanagutti.fds@spu.ac.in9727756155

Outcome results

None listed

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