Skip to main content
Clinical Trials/CTRI/2025/03/083178
CTRI/2025/03/083178
Not yet recruiting
Phase 2

A randomised controlled study for effectiveness of ultrasound guided regular alveolar recruitment upon pre-extubation lung atelectasis in pediatric population below 2 years ofage, undergoing posterior sagittal anorectoplasty surgery.

SMS medical college jaipur1 site in 1 country60 target enrollmentStarted: April 15, 2025Last updated:

Overview

Phase
Phase 2
Status
Not yet recruiting
Sponsor
SMS medical college jaipur
Enrollment
60
Locations
1
Primary Endpoint
1. Mean consolidation score of various lung regions.

Overview

Brief Summary

Atelectasis is a common complication in paediatric patients undergoing general anaesthesia, particularly in those under three years old, due to their reduced functional residual capacity and increased airway collapsibility. This randomised controlled interventional study aims to evaluate the effectiveness of regular alveolar recruitment using ultrasound in preventing intraoperative lung atelectasis in paediatric patients undergoing PSARP surgery in the prone position.

The study will compare two groups, one receiving a single alveolar recruitment manoeuvre at the start of the surgery and the other undergoing hourly alveolar recruitment. Lung ultrasound will be used to assess lung consolidation and B- line scores before extubation, The primary objective is to determine whether alveolar recruitment significantly reduces the incidence of pre- extubation atelectasis.

The null hypothesis states that there is no significant difference in occurrence of atelectasis between the two groups, and the alternative hypothesis proposes that regular recruitment reduces atelectasis. The study’s findings could provide valuable insights into optimizing intraoperative ventilation strategies to improve respiratory outcomes in paediatric anaesthesia.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant Blinded

Eligibility Criteria

Ages
1.00 Day(s) to 24.00 Month(s) (—)
Sex
All

Inclusion Criteria

  • Consenting parents or guardians.
  • patient posted for elective Posterior Sagittal Anorectoplasty.
  • surgery duration more than 1 hour.
  • ASA grade 1 and 2.

Exclusion Criteria

  • Patient who is a part of any other study.
  • Non-consenting parent/guardian.
  • Patients with previous thoracic surgery.
  • History of lung disease, airway anomalies, or airway infection.

Outcomes

Primary Outcomes

1. Mean consolidation score of various lung regions.

Time Frame: 1. baseline supine scan- after induction of general anaesthesia. (0 min) | 2. baseline prone scan - after prone positioning of the patient. (5min) | 3. At 1hr, 2hr till surgery is complete.

2. Mean B-line score of various lung regions.

Time Frame: 1. baseline supine scan- after induction of general anaesthesia. (0 min) | 2. baseline prone scan - after prone positioning of the patient. (5min) | 3. At 1hr, 2hr till surgery is complete.

Secondary Outcomes

  • 1. Mean number of episodes of Desaturation (SpO2 less than 95%) during mechanical ventilation, emergence from general anaesthesia, and the postoperative period (upto 12 hours).(2. Mean episodes of hypotension during alveolar recruitment.)

Investigators

Sponsor
SMS medical college jaipur
Sponsor Class
Government medical college

Study Sites (1)

Loading locations...

Similar Trials