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A study to compare two methods of inserting tube in the windpipe (oro-tracheal intubation) in children requiring ventilator support

Comparison Of Videolaryngoscopy And direct laRyngoscopy for pedIatric oro-trAcheal iNTubation in an oncology ICU (COVARIANT): A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/057898
Enrollment
150
Registered
2023-09-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

Health Condition 1: C00-D49- Neoplasms

Interventions

Intervention1: Videolaryngoscope (BPL): In VL, the scope incorporates an integrated camera and display monitor, which is used for indirect laryngoscopy to view the airway structures Since the view is

Sponsors

Tata Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children age between 1 to 12 years admitted in ICU who need oro-tracheal intubation

Exclusion criteria

Exclusion criteria: a) Age 12 years b) Unstable C-spine c) Cardiac arrest scenario d) Children on palliative care intent

Design outcomes

Primary

MeasureTime frame
First attempt success rate of orotracheal intubation in critically ill children with cancer.Timepoint: Immediately post intubation—

Secondary

MeasureTime frame
1. Time required for orotracheal intubation 2. Incidence of mild desaturation (92%) 3. Incidence of sever desaturation (to 85%) 4. Glottic view: POGO score & CL grade 5. Need for External laryngeal manipulation 6. Need for adjuncts to intubation 7. Adverse events such as Oral bleeding, Lip trauma, Dental trauma, Bronchospasm, Cardiac arrythmia, Hypotension, Esophageal intubation, Cuff rupture Sub-cutaneous emphysema, Pneumothorax will be noted Timepoint: Immediately post intubation—

Countries

India

Contacts

Public ContactDr Rohidas Mahale

Tata Memorial Hospital

kaivalyaak@yahoo.co.in9869077526

Outcome results

None listed

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