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Volume Versus Pressure Ventilation on Lung Atelectasis

Primary Purpose

Cardiac Congenital Defects

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
LMA (Laryngeal Mask Airway)
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiac Congenital Defects focused on measuring pediatric cardiac catheterization, lung ultrasound score, lung atelectasis, LMA

Eligibility Criteria

2 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Pediatric patients undergoing cardiac catheterization procedures. Age from 2 years to 6 years of both sexes. Exclusion Criteria: Lung score at different times. Age <2 years and >6 years. Preoperative mechanical ventilation. Heart failure (any inotropic support infusion). Patients with any lung diseases( acute respiratory disease, pulmonary or lung diseases). Lung consolidation score ≥ 2 before insertion of LMA. Any contraindication for LMA insertion (risk for aspiration, and/or airway obstruction below the larynx.) Procedures exceeding 120 mins duration.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Group A pressure control ventilation

    Group B volume control ventilation

    Arm Description

    Inspiratory pressure was adjusted to achieve an expired tidal volume of 7 ml/Kg, respiratory rate was adjusted to achieve an end ETCO2 at 32-35 mmHg, inspiratory to expiratory ratio at 1:2, PEEP at 4 cm H2O and FiO2 at 0.5 providing that the maximum airway pressure was limited to 25 cmH2O.

    VT adjacent to 7 ml/Kg, respiratory rate was adjusted to achieve an end ETCO2 at 32-35 mmHg and I/E at: 1:2 and PEEP at 4 cm H2O and FiO2 at 0.5.

    Outcomes

    Primary Outcome Measures

    Post operative incidence of Lung atelectasis immediate post-removal of LMA.
    calculate lung score using lung ultrasound

    Secondary Outcome Measures

    Correlation between lung score and PaO2 /FiO2 ratio
    Arterial blood gases (ABG) in different time

    Full Information

    First Posted
    September 27, 2023
    Last Updated
    October 10, 2023
    Sponsor
    Kasr El Aini Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06076395
    Brief Title
    Volume Versus Pressure Ventilation on Lung Atelectasis
    Official Title
    The Effect of Volume Controlled Versus Pressure Ventilation on Anesthesia Induced Lung Atelectasis in Pediatrics Using Laryngeal Mask Airway (LMA )During Cardiac Catheterization. A Prospective Randomized Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    July 2024 (Anticipated)
    Study Completion Date
    August 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kasr El Aini Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This prospective randomized comparative study, to assess post-operative lung atelectasis by comparing calculated lung score using ultrasound between pediatric patients intubated with LMA (laryngeal mask airway) under volume versus pressure controlled modes of ventilation.
    Detailed Description
    The initial US scanning will be done prior to the induction of anesthesia. Induction of anesthesia using 4% sevoflurane. Adequate size LMA will be inserted after adequate depth of anesthesia adjusted. Group A (n=25): will receive pressure-controlled ventilation (PCV). Group B (n=25): will receive volume-controlled ventilation (VCV). US scanning and Arterial blood gases at the following: T1(After maintenance of anesthesia). T2 (One minute after applying groin bandage and before extubation). T3 (10 minutes after extubation and resumption of adequate regular breathing). T4 (30 min post extubation).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiac Congenital Defects
    Keywords
    pediatric cardiac catheterization, lung ultrasound score, lung atelectasis, LMA

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    For group A pressure control ventilation will be adjusted as follows: Inspiratory pressure will be adjusted to achieve an expired tidal volume of 7 ml/Kg, respiratory rate will be adjusted to achieve an end ETCO2 at 32-35 mmHg, inspiratory to expiratory ratio at 1:2, PEEP at 4 cm H 2 O and FiO2 at 0.5 providing that the maximum airway pressure will be limited to 25 cmH2O. For group B volume control ventilation will be adjusted as follows: tidal volume (VT) adjacent to 7 ml/Kg, respiratory rate will be adjusted to achieve an end ETCO2 at 32-35 mmHg and I/E at: 1:2 and positive end expiratory pressure (PEEP)at 4 cmH2O and FiO2 at 0.5.
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    Patients will be randomly allocated by a computer-generated list (www.randomization.com) into one of the study groups in the day of the study . The randomization sequence will be concealed in sealed envelopes and will be opened by an independent nurse. The data collector and data analysis will be blind to group assignments.
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A pressure control ventilation
    Arm Type
    Experimental
    Arm Description
    Inspiratory pressure was adjusted to achieve an expired tidal volume of 7 ml/Kg, respiratory rate was adjusted to achieve an end ETCO2 at 32-35 mmHg, inspiratory to expiratory ratio at 1:2, PEEP at 4 cm H2O and FiO2 at 0.5 providing that the maximum airway pressure was limited to 25 cmH2O.
    Arm Title
    Group B volume control ventilation
    Arm Type
    Experimental
    Arm Description
    VT adjacent to 7 ml/Kg, respiratory rate was adjusted to achieve an end ETCO2 at 32-35 mmHg and I/E at: 1:2 and PEEP at 4 cm H2O and FiO2 at 0.5.
    Intervention Type
    Device
    Intervention Name(s)
    LMA (Laryngeal Mask Airway)
    Other Intervention Name(s)
    Lung Ultrasound
    Intervention Description
    Pressure controlled versus Volume controlled ventilation using LMA
    Primary Outcome Measure Information:
    Title
    Post operative incidence of Lung atelectasis immediate post-removal of LMA.
    Description
    calculate lung score using lung ultrasound
    Time Frame
    immediated post removal of LMA
    Secondary Outcome Measure Information:
    Title
    Correlation between lung score and PaO2 /FiO2 ratio
    Description
    Arterial blood gases (ABG) in different time
    Time Frame
    From the preoperative period (T0) to 30 minutes post-extubation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Pediatric patients undergoing cardiac catheterization procedures. Age from 2 years to 6 years of both sexes. Exclusion Criteria: Lung score at different times. Age <2 years and >6 years. Preoperative mechanical ventilation. Heart failure (any inotropic support infusion). Patients with any lung diseases( acute respiratory disease, pulmonary or lung diseases). Lung consolidation score ≥ 2 before insertion of LMA. Any contraindication for LMA insertion (risk for aspiration, and/or airway obstruction below the larynx.) Procedures exceeding 120 mins duration.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dalia Saad, ass prof
    Phone
    01223911524
    Ext
    00202
    Email
    dalia_saad@kasralainy.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amel Hanfy Abo El-Ela, professor
    Email
    :dr_amel@hotmail.com:
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amel Hanfy Abo El- Ela
    Organizational Affiliation
    Kasr El Aini Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    12029240
    Citation
    Hedenstierna G. Airway closure, atelectasis and gas exchange during anaesthesia. Minerva Anestesiol. 2002 May;68(5):332-6.
    Results Reference
    background
    PubMed Identifier
    34359177
    Citation
    Stefanik E, Drewnowska O, Lisowska B, Turek B. Causes, Effects and Methods of Monitoring Gas Exchange Disturbances during Equine General Anaesthesia. Animals (Basel). 2021 Jul 9;11(7):2049. doi: 10.3390/ani11072049.
    Results Reference
    background
    PubMed Identifier
    30048331
    Citation
    Chiumello D, Mongodi S, Algieri I, Vergani GL, Orlando A, Via G, Crimella F, Cressoni M, Mojoli F. Assessment of Lung Aeration and Recruitment by CT Scan and Ultrasound in Acute Respiratory Distress Syndrome Patients. Crit Care Med. 2018 Nov;46(11):1761-1768. doi: 10.1097/CCM.0000000000003340.
    Results Reference
    background
    PubMed Identifier
    35792663
    Citation
    Rodriguez-Fanjul J, Corsini I, Orti CS, Bobillo-Perez S, Raimondi F. Lung ultrasound to evaluate lung recruitment in neonates with respiratory distress (RELUS study). Pediatr Pulmonol. 2022 Oct;57(10):2502-2510. doi: 10.1002/ppul.26066. Epub 2022 Jul 12.
    Results Reference
    background
    PubMed Identifier
    36084154
    Citation
    Li X, Liu B, Wang Y, Xiong W, Zhang Y, Bao D, Liang Y, Li L, Liu G, Jin X. The effects of laryngeal mask airway versus endotracheal tube on atelectasis in patients undergoing general anesthesia assessed by lung ultrasound: A protocol for a prospective, randomized controlled trial. PLoS One. 2022 Sep 9;17(9):e0273410. doi: 10.1371/journal.pone.0273410. eCollection 2022.
    Results Reference
    background
    PubMed Identifier
    24662376
    Citation
    Acosta CM, Maidana GA, Jacovitti D, Belaunzaran A, Cereceda S, Rae E, Molina A, Gonorazky S, Bohm SH, Tusman G. Accuracy of transthoracic lung ultrasound for diagnosing anesthesia-induced atelectasis in children. Anesthesiology. 2014 Jun;120(6):1370-9. doi: 10.1097/ALN.0000000000000231.
    Results Reference
    background

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