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Intubation in neonates with two different type of tubes

Comparison of Microcuffed Vs Uncuffed Endotracheal Tubes for Airway Management in Neonates During General Anaesthesia: A Randomized Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/041906
Enrollment
50
Registered
2022-04-19
Start date
Unknown
Completion date
Unknown
Last updated
2022-05-02

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Group MC: The airway will be secured with micro cuffed ETT in neonates scheduled for surgeries expected to last for less than one hour duration under GA Control Intervention1: Group UC

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All neonates of either sex, (0 to 28 days), weight >=2.5 kg, gestation age >37wks with COPUR score between 5-10, ASA grade I and II, scheduled for surgeries expected to last for less than one-hour duration under general anaesthesia in the supine position

Exclusion criteria

Exclusion criteria: The neonates whose parents refused to be a part of the study. Any neonate with abnormal or distorted anatomy of the airway or with obstruction of the airway beyond the larynx like a foreign body, mass(cancer), strictures, congenital obstruction, vocal cord scarring, inflammatory conditions like laryngitis, bronchitis, laryngeal papillomatosis. Neonates with any history of seizures, prematurity, or weight If we face difficulty in ventilating a neonate then that neonate will not be a part of the study. Those neonates who are already on mechanical ventilation or oxygen therapy or were on ventilatory support in the past 15 days will be excluded from the study. Neonates who are in sepsis, MODS, having any electrolyte abnormalities, on vasopressor support or haemodynamic support.

Design outcomes

Primary

MeasureTime frame
To determine and compare air leak around micro cuffed vs uncuffed endotracheal tubes by analyzing inspiratory and expiratory tidal volumes under controlled ventilation in neonates during general anesthesia.Timepoint: 2 HRS

Secondary

MeasureTime frame
1.Intubation time 2.Perioperative manipulations required (changing of tube cuffed/uncuffed, repositioning of tube, throat pack insertion, need to increase the inspiratory pressure to reach acceptable tidal volume). 3. Number of attempts to insert and correctly size the tracheal tube. 4.Any difference in hemodynamic changes during intubation between two groups 5.Post operative complicationsTimepoint: 2 HRS

Countries

India

Contacts

Public ContactDr Geeta Singariya

Dr. S.N. medical collage, Jodhpur

123joshi.kritika@gmail.com9414869641

Outcome results

None listed

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