LUS and Consequences of High FiO2 in Children

Perioperative/Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04581226
• Other study ID #: 17101201
• Status: Completed
• Start date: January 12, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: July 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 6 Years

Eligibility

Inclusion criteria:

• 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.

Exclusion criteria:

• 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.

Related Conditions & MeSH terms

• Perioperative/Postoperative Complications
• Postoperative Complications

Intervention

Diagnostic Test:
• Lung ultrasound
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)

Locations

Country	Name	City	State
Egypt	Assiut university Pediatric hospital	Assiut	Assiut Governorate
Egypt	Hala Abdel-Ghaffar	Asyut	Asyut Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	LUS-B-line Score	Lung ultrasound B-Line score. The degree of B-lines will be assessed by the ''B-lines score'' that is divided into four grades and scored between 0 and 3: (0) fewer than three isolated B-lines; (1) multiple well-defined B-lines; (2) multiple coalescent B-lines; and (3) white lung,	It will be recorded intraoperative to 2hours postoperative.