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a study to find whether a modified device for supplying oxygen to children while an inserting a tube into the windpipe (trachea) through either the mouth or nose to help someone breathe during full mouth rehabilation

Evaluation of a Novel Endotracheal Tube Connector with an Auxiliary Oxygenation Port for Apneic Oxygenation During Nasal Intubation in Children Aged 2 6 Years Undergoing Full Mouth Rehabilitation Under General Anesthesia- A Randomised Control Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089401
Enrollment
60
Registered
2025-06-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Health Condition 1: K049- Other and unspecified diseases ofpulp and periapical tissues

Interventions

Intervention1: Modified Endo Tracheal Tube Connector: Use of a modified pediatric endotracheal tube connector featuring an additional lateral oxygenation port (equipped with a unidirectional valve or

Sponsors

Ashish Suresh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.children aged 2 to 6 years 2.ASA physical status I or II 3.Scheduled for full-mouth dental rehabilitation under general anesthesia 4.Undergoing nasal endotracheal intubation with a standard pediatric ET tube (ID 3.0 5.5 mm) 5.Written informed consent obtained from parents or legal guardians 6.Cases requiring or benefitting from apneic or supplemental oxygenation during intubation

Exclusion criteria

Exclusion criteria: 1.Children with upper airway anomalies or craniofacial syndromes (e.g., Pierre Robin, Treacher Collins) 2.ASA physical status III or higher 3.Anticipated or documented difficult airway 4.Emergency procedures requiring rapid sequence intubation 5.Refusal of consent by parent or guardian 6.Known hypersensitivity to materials used in the connector (polycarbonate, polypropylene)

Design outcomes

Primary

MeasureTime frame
rate of oxygen desaturation during intubationTimepoint: at baseline and post general anesthesia—

Secondary

MeasureTime frame
patient heart rate and blood pressureTimepoint: at baseline and post general anesthesia—

Countries

India

Contacts

Public ContactSubramanian E M G

Saveetha Dental College and Hospitals

subramanian@saveetha.com9884125380

Outcome results

None listed

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