a study to understand the changes in lung after corona virus infection in children undergoing heart surgery, using ultrasound examination.

Completed

• Conditions: Coronavirus as the cause of diseases classified elsewhere, (2) ICD-10 Condition: I519||Heart disease, unspecified,

• Registration Number: CTRI/2022/07/043846
• Lead Sponsor: SCTIMST

Brief Summary

This prospective, non- randomized observational pilot study will be conducted in Pediatric cardiac surgery Operation Theatre and Intensive Care Unit of SCTIMST. Written informed consent will be taken from the patient’s parents during pre-anesthetic check-up. Lung ultrasound will be performed after intubation in OT. Once inclusion and exclusion criteria are satisfied, patients will be allotted into the study. The 2 groups of allotment are Group A-patients who were once positive for SARS COVID-19 by RT PCR or Antigen Tests and Group B- patients who have never been COVID positive. Group A will be further divided intoa) Patients who received in hospital care for COVID-19 andb) Patients who were in domiciliary careBasic Lung Ultrasound Examination (BLUE) protocol will be utilized for the study. After surgery, before resuming ventilation, lungs will be recruited to avoid the confounding effect of atelectasis. End will be visual inflation of both the lungs in the surgical field, at a peak inspiratory pressure of less than 30 cm H2O to avoid barotrauma. In ICU, pulmonary ultrasound will be repeated for both group A and Group B patients on post-operative Day 0, before extubating. Presence of consolidation, pleural effusion, collapse, and pneumothorax will be documented as positive lung ultrasound findings. In case of any positive findings, lung ultrasound will be repeated daily till resolution. Patients will be followed up for assessment of the duration of ventilation, incidence of re-intubation, incidence of pulmonary infection (documented by clinical signs, radiological signs, and laboratory criteria of pneumonia), duration of ICU stay, in-hospital mortality and 30-Day Mortality. Arterial blood gas analysis with specific reference to partial pressure of oxygen and partial pressure of carbon dioxide, will also be documented.Measurements performed by the principle and co-investigators will be compared.

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-01-11
• Study Start: 2022-11-07
• Last Update Posted: 2022-11-23

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Pediatric patients posted for corrective congenital cardiac surgeries in SCTIMST.
• Optimal images for lung ultrasound.

Exclusion Criteria

• Emergency and Redo surgeries.
• Patients with active pulmonary infection preoperatively.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Post-opertaive respiratory infection measured by clinical signs, radiological signs, laboratory criteria for pneumonia	Baseline, post op day 1, At the time of discharge from ICU
2.	Baseline, post op day 1, At the time of discharge from ICU

Secondary Outcome Measures

Name	Time	Method
30 Day mortality	Estimated daily till 30th day
Reintubation	Daily till 3rd day
ICU Mortality	Daily till discharge from ICU

Trial Locations

Locations (1)

Sree Chitra Thirunal Institute for Medical Sciences and Technology; 🇮🇳 Thiruvananthapuram, KERALA, India

Sree Chitra Thirunal Institute for Medical Sciences and Technology

🇮🇳Thiruvananthapuram, KERALA, India

Dr Mamatha Munaf

Principal investigator

7094013291

mamathamunaf@gmail.com