LUS and Consequences of High FiO2 in Children

NCT04581226 | Completed DMC

• 1 other identifier: 17101201
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is

1. 1.to evaluate effect of high FiO2 on the development of intraoperative atelectasis in mechanically ventilated children using LUS.
2. 2.to investigate the correlation between lung consolidation score and patient clinical variables including pulmonary mechanics, Sao2%, ABG, and perioperative respiratory complications.

Conditions

Perioperative/Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• LUS-consolidation Score

  The lung ultrasound consolidation score that is divided into four grades and scored between 0 and 3: (0) no consolidation; (1) minimal juxta-pleural consolidation; (2) small-sized consolidation; and (3) large-sized consolidation. Anesthesia-induced atelectasis will be defined to be significant if any region had a consolidation score of ≥ 2.

  It will be recorded intraoperative to 2hours postoperative.

Secondary Outcomes (1)

• LUS-B-line Score

  It will be recorded intraoperative to 2hours postoperative.

Study Arms (1)

Lung ultrasound

Sonographic assessments including the lung consolidation score, B-line score and Lung aeration score will be recorded 1min. after intubation, at end of surgery and 2h postoperatively.

Diagnostic Test: Lung ultrasound

Interventions

Lung ultrasound DIAGNOSTIC_TEST

All children will be studied in the supine position. LUS will be performed with the portable device MicroMax (Sonosite, Bothell, Washington, USA) using a linear probe of 6 to 12 MHz. All ultrasound scans will be performed by the same anesthetist, who has experience of more than 30 lung ultrasound scans in pediatric patients. Each hemithorax will be divided into six regions, using three longitudinal lines (parasternal, anterior and posterior axillary) and two axial lines (one above the diaphragm and the other 1 cm above the nipples)

Also known as: Lung Sonar

Lung ultrasound

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Age of 1-6 years. * ASA physical status (I-II). * Endotracheal intubation and mechanical ventilation. * Elective non-abdominal and non-thoracic surgery * lasting for more than 2 hours.

You may qualify if:

• Age of 1-6 years.
• ASA physical status (I-II).
• Endotracheal intubation and mechanical ventilation.
• Elective non-abdominal and non-thoracic surgery
• lasting for more than 2 hours.

You may not qualify if:

• ASA classification more than II
• Thoracic or abdominal surgery.
• pre-existing lung disease.
• Pre-operative chest infection or abdominal chest US finding. Any thoracic deformity Patients with cardiac, liver or kidney disease.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (2)

Assiut university Pediatric hospital

Asyut, Assiut Governorate, 715715, Egypt

Location

Hala Abdel-Ghaffar

Asyut, Asyut Governorate, 71515, Egypt

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hala S Abdel-Ghaffar, MD

  Professor of anesthesia and intensive care.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of anesthesia and intensive care

Study Record Dates

• First Submitted: September 20, 2020
• First Posted: October 9, 2020
• Study Start: January 12, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)