LUS and Consequences of High FiO2 in Children

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04581226
Collaborator
(none)
86
2
1
15.6
43
2.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Lung ultrasound
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
86 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Our hypothesis is that clinical data are necessary to validate the lung sonographic findings of atelectasis and The purpose of this study is to evaluate effect of high FiO2 on the development of intraoperative atelectasis in mechanically ventilated children using LUS. to investigate the correlation between lung consolidation score and patient clinical variables including pulmonary mechanics, Sao2%, ABG, and perioperative respiratory complications. negative consequences of administrating high perioperative oxygen concentration.Our hypothesis is that clinical data are necessary to validate the lung sonographic findings of atelectasis and The purpose of this study is to evaluate effect of high FiO2 on the development of intraoperative atelectasis in mechanically ventilated children using LUS. to investigate the correlation between lung consolidation score and patient clinical variables including pulmonary mechanics, Sao2%, ABG, and perioperative respiratory complications. negative consequences of administrating high perioperative oxygen concentration.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
'Correlation Between Lung Ultrasound Findings and Clinical Consequences of High Intraoperative Inspired Oxygen Fraction During Elective Surgery in Mechanically Ventilated Children''
Actual Study Start Date :
Jan 12, 2021
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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
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)
Other Names:
  • Lung Sonar
  • Outcome Measures

    Primary Outcome Measures

    1. LUS-consolidation Score [It will be recorded intraoperative to 2hours postoperative.]

      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.

    Secondary Outcome Measures

    1. LUS-B-line Score [It will be recorded intraoperative to 2hours postoperative.]

      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,

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 6 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut university Pediatric hospital Assiut Assiut Governorate Egypt 715715
    2 Hala Abdel-Ghaffar Asyut Asyut Governorate Egypt 71515

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Principal Investigator: Hala S Abdel-Ghaffar, MD, Professor of anesthesia and intensive care.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hala Saad Abdel-Ghaffar, Professor of anesthesia and intensive care, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04581226
    Other Study ID Numbers:
    • 17101201
    First Posted:
    Oct 9, 2020
    Last Update Posted:
    Jan 13, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 13, 2021