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A study comparing two aids(dental putty vs gauze roll) for easier and safer intubation in children with cleft lip and palate.

A Prospective Randomised Clinical Trial For Comparison of Dental Putty-Aided Endotracheal Intubation Versus Gauze Roll-Aided Endotracheal Intubation in Children with Left-Sided Complete Cleft Lip, Alveolus, and Palate. - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/098476
Enrollment
60
Registered
2025-12-04
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Health Condition 1: Q371- Cleft hard palate with unilateralcleft lip

Interventions

Intervention1: Dental Putty aided endotracheal intubation: Dental Putty aided endotracheal intubation Control Intervention1: Gauze Roll aided endotracheal intubation: Gauze Roll aided endotracheal int

Sponsors

Pavan Dhulkhed
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children aged less than 5 years 2. ASA physical status 1 or 2 3. Diagnosed with uncorrected left sided complete cleft lip, alveolus and palate

Exclusion criteria

Exclusion criteria: 1. Children with anticipated difficult airway unrelated to cleft 2. ASA physical status greater than 2

Design outcomes

Primary

MeasureTime frame
Primary Outcome is the Time required for successful endotracheal intubation. (Intubation time)Timepoint: Study parameters are recorded at the end of endotracheal intubation in both groups.

Secondary

MeasureTime frame
1. Number of attempts of endotracheal intubation 2. To compare Cormack-Lehane grades of glottic visualisation 3. To assess the need for external laryngeal manipulation 4. To grade the ease of intubation 5. To document complications like failed intubation, desaturation & mucosal injury.Timepoint: The secondary outcome parameters are recorded at the end of endotracheal intubation.

Countries

India

Contacts

Public ContactPavan Dhulkhed

SDM College of Medical Sciences and Hospital, Dharwad.

pavandhulkhed1984@gmail.com8150885678

Outcome results

None listed

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