Clinical trial NCT06076395: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiac Congenital Defects
Keywords: pediatric cardiac catheterization
lung ultrasound score
lung atelectasis
LMA
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: DIAGNOSTIC

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).

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 \&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.

Primary outcomes:
measure: Post operative incidence of Lung atelectasis immediate post-removal of LMA.
timeFrame: immediated post removal of LMA
Secondary outcomes:
measure: Correlation between lung score and PaO2 /FiO2 ratio
timeFrame: From the preoperative period (T0) to 30 minutes post-extubation
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Dalia Saad
Study officials:
affiliation: Kasr El Aini Hospital
name: Amel Hanfy Abo El- Ela
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.
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.