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How balloon pressure in breathing tubes affects throat narrowing in babies: An observational study

Effect of endotracheal tube cuff pressure on change in subglottic diameter in infants: An observational study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/04/109049
Enrollment
100
Registered
2026-04-22
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: J955- Postprocedural subglottic stenosis

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil

Sponsors

Lady hardinge medical college
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Infants undergoing general anaesthesia requiring endotracheal intubation

Exclusion criteria

Exclusion criteria: Haemodynamically unstable patient Anticipated difficult airway Anatomical deformity of larynx / trachea (laryngomalacia/tracheomalacia/ tracheoesophageal fistula) Presence of mass, scar or ulcer in the neck Anticipated duration of surgery more than 3 hour. Infant with respiratory tract infection

Design outcomes

Primary

MeasureTime frame
Correlation between endotracheal tube cuff pressure and change in subglottic diameter measured in millimetres by ultrasonography preoperatively and at extubation in infants.Timepoint: Preoperatively at the time of intubation and at extubation

Secondary

MeasureTime frame
Mean cuff pressure required to achieve satisfactory ventilation Mean volume of air (in millilitres) required to inflate the cuff to achieve satisfactory ventilation Proportion of infants having associated complications viz hoarseness of voice, cough, stridor up to 24hours after extubationTimepoint: Endotracheal cuff pressure at 30min 1hour and every 30min till end of surgery Volume of air in the cuff at the time of cuff inflation Post operative stridor hoarseness or cough for 24 hours post operative period

Countries

India

Contacts

Public ContactAngel Maria Baby

Lady Hardinge Medical college

doc_1998@rediff.com9999353519

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026