Clinical Trials Directory

Trials / Completed

CompletedNCT04581226

LUS and Consequences of High FiO2 in Children

'Correlation Between Lung Ultrasound Findings and Clinical Consequences of High Intraoperative Inspired Oxygen Fraction During Elective Surgery in Mechanically Ventilated Children''

Status
Completed
Phase
Study type
Observational
Enrollment
33 (actual)
Sponsor
Assiut University · Academic / Other
Sex
All
Age
1 Year – 6 Years
Healthy volunteers
Not accepted

Summary

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

Detailed description

The WHO and United States centers for disease control and prevention (CDC) recently recommended the administration of 80% inspired oxygen fraction (Fio2) during and immediately after surgery performed with general anesthesia and endotracheal intubation. The recommendation was based on some data suggesting that intra-operative high Fio2 reduces incidence of surgical site infections. The dilemma of applying high or low perioperative FiO2 arises in daily practice of pediatric anesthesia because children are at increased risk of developing hypoxemia due to their physiological characteristics including smaller functional residual capacity and increased metabolic requirement compared with adult. However, considering that atelectasis occurs in most pediatric patients undergoing general anesthesia, it is important to titrate perioperative level of FiO2 to minimize the risk of developing atelectasis and hypoxemia. The use of FiO2 80% at induction and emergence, whilst limiting FiO2 to 35% during maintenance of anesthesia, may prevent the occurrence of atelectasis and ensure sufficient oxygenation. Conversely, the use of FiO2 100% at induction and emergence, which is reduced to FiO2 80% during maintenance of anesthesia, may increase the margin of safety to avoid hypoxemia. In children, the pulmonary consequences of using high FiO2 during general anesthesia have not been fully characterized over the early perioperative period. LUS has shown reliable sensitivity and specificity for diagnosis of anesthesia-induced atelectasis in children \[7\]. It can identify children needing a recruitment maneuver to re expand their lung and help optimize ventilator treatment during anesthesia. Our hypothesis is that clinical data are necessary to validate the lung sonographic findings of atelectasis and negative consequences of administrating high perioperative oxygen concentration.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTLung ultrasoundAll 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)

Timeline

Start date
2021-01-12
Primary completion
2022-12-01
Completion
2022-12-01
First posted
2020-10-09
Last updated
2023-07-25

Locations

2 sites across 1 country: Egypt

Source: ClinicalTrials.gov record NCT04581226. Inclusion in this directory is not an endorsement.