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“Clinical trial to compare gestation age- based, weight-based, and nasal-tragus length method for estimation of optimal insertion depth of endotracheal tube in neonates ?

“Comparison of gestation age- based, weight-based, and nasal-tragus length method for estimation of optimal insertion depth of endotracheal tube: An open label randomized controlled trial ? - ODEN

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/12/048221
Enrollment
150
Registered
2022-12-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

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

Conditions

Health Condition 1: J969- Respiratory failure, unspecified

Interventions

Intervention1: Estimation of insertion depth of endotracheal tube using gestation age-based method: Neonates who need mechanical ventilation will be intubated and insertion depth of endotracheal tube

Sponsors

abhishek yadav
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Neonates born in the hospital between 25+0 weeks and 41+6 weeks gestation age will be included if they are intubated for ventilation during the neonatal period(0-28 days)

Exclusion criteria

Exclusion criteria: 1.Major congenital malformation including craniofacial malformation 2.Neonates with any suspected chromosomal disorder 3.Intubation during neonatal resuscitation at birth 4.Intubation during emergency 5.Neonates 6.Chest radiograph not likely to be available within 6 hours of intubation 7.Re-intubation

Design outcomes

Primary

MeasureTime frame
Proportion of optimally placed endotracheal tube tip (between the upper border of T1 and lower border of T2 vertebra in chest radiograph)Timepoint: within 6 hours of intubation

Secondary

MeasureTime frame
1.Incidence of ETT tip being too high (above the upper border of the first thoracic vertebra) 2.Incidence of ETT tip being too low (below the lower border of the second thoracic vertebra) 3.Incidence of ETT tip at the level of the carina 4.Episodes of bradycardia (heart rate100 beats/min) within 30 minutes of intubation 5.New onset pneumothorax within 6 hours of intubation 6.Need for ETT repositioning after chest radiograph 7.New onset intraventricular hemorrhage (any grade) within 24 hours of intubation 8.Duration of invasive ventilation 9.Death before discharge Timepoint: After recruitment of 150 cases

Countries

India

Contacts

Public ContactDrSuksham Jain

Government Medical College and Hospital,32,Chandigarh

dr.sukshamj@gmail.com9988901596

Outcome results

None listed

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