Volume Versus Pressure Ventilation on Lung Atelectasis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-12

Study Completion Date

2024-08-31

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.

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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).

Conditions

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Cardiac Congenital Defects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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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.

Group Type EXPERIMENTAL

LMA (Laryngeal Mask Airway)

Intervention Type DEVICE

Pressure controlled versus Volume controlled ventilation using LMA

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.

Group Type EXPERIMENTAL

LMA (Laryngeal Mask Airway)

Intervention Type DEVICE

Pressure controlled versus Volume controlled ventilation using LMA

Interventions

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LMA (Laryngeal Mask Airway)

Pressure controlled versus Volume controlled ventilation using LMA

Intervention Type DEVICE

Other Intervention Names

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Lung Ultrasound

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 \<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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No