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Comparing Two Breathing Methods to See Which Helps Premature Babies Recover Faster After Eye Surgery

A prospective Randomized Comparative analysis between LMA vs ETT for Recovery time in Preterm infants for ROP eye surgeries - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088013
Enrollment
40
Registered
2025-06-02
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Health Condition 1: H00-H59- Diseases of the eye and adnexa

Interventions

Intervention1: LMA: The preterm infants undergoing ROP eye surgeries under general anesthesia will undergo inhalation induction and no muscle relaxant will be given, LMA airway device will be inserted

Sponsors

AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Infants less than 1 year of age of either gender posted for any ROP intervention in the OT. 2) Patients belonging to the American Society of Anesthesiologists Physical Status Grade I, II, or III. 3) Guardians giving willful consent for the participation in the study

Exclusion criteria

Exclusion criteria: 1) Patients with restricted mouth opening. 2) Patients with airway obstruction. 3) Patients with distorted airway. 4) Patients with history of stiff lungs, recent pneumonia. 5) Patients with history of recent upper respiratory tract infections.

Design outcomes

Primary

MeasureTime frame
To observe postoperative recovery time between laryngeal mask airway and ETT that is being used in infants presenting for ROP procedures.Timepoint: Post extubation- 1 hrs, 2hrs, 3 hrs and 24 hrs post extubation

Secondary

MeasureTime frame
To study this population in terms of Patient demography- birth weight, birth week, gender First pass success rate Duration of insertion Ease of insertion Number of attempts Airway adjunct used Desaturation, bradycardia during insertion Time for extubation Perioperative complications Transfer to NICU for mechanical ventilation Timepoint: 1) post induction (5,10,15,20 minutes)- number of attempts, ease of insertion, time taken for insertion 2) intraoperative duration(1 to 2 hrs)- any events , desaturation 3) post extubation( 15, 30,45 minutes )- time taken for extubation, requirement of mechanical ventilation

Countries

India

Contacts

Public ContactDr Sushmita Bairagi

Department of anesthesia, AIIMS, Delhi

sushmita.bairagi91@gmail.com09953060597

Outcome results

None listed

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