Volume Versus Pressure Ventilation on Lung Atelectasis

Not Applicable

Active, not recruiting

• Conditions: Cardiac Congenital Defects
• Interventions: Device: LMA (Laryngeal Mask Airway)

• Registration Number: NCT06076395
• Lead Sponsor: Kasr El Aini Hospital

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).

Study Timeline

• Study First Submitted: 2023-09-27
• Study First Submitted QC: 2023-10-06
• Study First Posted: 2023-10-10
• Status Verified: 2024-01
• Study Start: 2024-01-12
• Last Update Submitted: 2024-01-14
• Last Update Posted: 2024-01-17
• Primary Completion: 2024-07
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B volume control ventilation	LMA (Laryngeal Mask Airway)	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.
Group A pressure control ventilation	LMA (Laryngeal Mask Airway)	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Dalia Saad; 🇪🇬 Cairo, Egypt