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Volume Versus Pressure Ventilation on Lung Atelectasis

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.

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06076395
Enrollment
60
Registered
2023-10-10
Start date
2024-01-12
Completion date
2024-08-31
Last updated
2024-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Congenital Defects

Keywords

pediatric cardiac catheterization, lung ultrasound score, lung atelectasis, LMA

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).

Interventions

DEVICELMA (Laryngeal Mask Airway)

Pressure controlled versus Volume controlled ventilation using LMA

Sponsors

Kasr El Aini Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, 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.

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.

Eligibility

Sex/Gender
ALL
Age
2 Years to 6 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Post operative incidence of Lung atelectasis immediate post-removal of LMA.immediated post removal of LMAcalculate lung score using lung ultrasound

Secondary

MeasureTime frameDescription
Correlation between lung score and PaO2 /FiO2 ratioFrom the preoperative period (T0) to 30 minutes post-extubationArterial blood gases (ABG) in different time

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026