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Volume Versus Pressure Ventilation on Lung Atelectasis

Sponsor
Kasr El Aini Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06076395
Collaborator
(none)
50
Enrollment
2
Arms
9
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: LMA (Laryngeal Mask Airway)
 N/A

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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:
Double (Participant, Outcomes 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.
Primary Purpose:
Diagnostic
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.
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A pressure control ventilation

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.

Device: LMA (Laryngeal Mask Airway)
Pressure controlled versus Volume controlled ventilation using LMA
Other Names:
  • Lung Ultrasound

    		•
    Experimental: Group B volume control ventilation

    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.

    Device: LMA (Laryngeal Mask Airway)
    Pressure controlled versus Volume controlled ventilation using LMA
    Other Names:
  • Lung Ultrasound

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Post operative incidence of Lung atelectasis immediate post-removal of LMA. [immediated post removal of LMA]

      calculate lung score using lung ultrasound

    Secondary Outcome Measures

    1. Correlation between lung score and PaO2 /FiO2 ratio [From the preoperative period (T0) to 30 minutes post-extubation]

      Arterial blood gases (ABG) in different time

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Kasr El Aini Hospital

    Investigators

    • Principal Investigator: Amel Hanfy Abo El- Ela, Kasr El Aini Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dalia Saad Abd-El Kader, assistant professor, Kasr El Aini Hospital
    ClinicalTrials.gov Identifier:
    NCT06076395
    Other Study ID Numbers:
    • MS-96-2023
    First Posted:
    Oct 10, 2023
    Last Update Posted:
    Oct 12, 2023
    Last Verified:
    Oct 1, 2023
    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
    Keywords provided by Dalia Saad Abd-El Kader, assistant professor, Kasr El Aini Hospital
    pediatric cardiac catheterization
    lung ultrasound score
    lung atelectasis
    LMA
    Additional relevant MeSH terms:
    Pulmonary Atelectasis
    Heart Defects, Congenital
    Congenital Abnormalities

    Study Results

    No Results Posted as of Oct 12, 2023