Volume Versus Pressure Ventilation on Lung Atelectasis

Study Overview
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Brief Summary
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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
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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).

Official Title
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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.

Conditions
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Cardiac Congenital Defects

Intervention / Treatment
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* Device: LMA (Laryngeal Mask Airway)


Participation Criteria
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Eligibility Criteria
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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 &lt;2 years and &gt;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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A pressure control ventilation<br>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)<br>* Pressure controlled versus Volume controlled ventilation using LMA<br>* Other names: Lung Ultrasound;|
| Experimental: Group B volume control ventilation<br>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)<br>* Pressure controlled versus Volume controlled ventilation using LMA<br>* Other names: Lung Ultrasound;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative incidence of Lung atelectasis immediate post-removal of LMA. | calculate lung score using lung ultrasound | immediated post removal of LMA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between lung score and PaO2 /FiO2 ratio | Arterial blood gases (ABG) in different time | From the preoperative period (T0) to 30 minutes post-extubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric cardiac catheterization, lung ultrasound score, lung atelectasis, LMA