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Volume Versus Pressure Ventilation on Lung Atelectasis

K

Kasr El Aini Hospital

Status

Active, not recruiting

Conditions

Cardiac Congenital Defects

Treatments

Device: LMA (Laryngeal Mask Airway)

Study type

Interventional

Funder types

Other

Identifiers

NCT06076395
MS-96-2023

Details and patient eligibility

About

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.

Full 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).

Enrollment

60 patients

Sex

All

Ages

2 to 6 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

Group A pressure control ventilation
Experimental group
Description:
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.
Treatment:
Device: LMA (Laryngeal Mask Airway)
Group B volume control ventilation
Experimental group
Description:
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.
Treatment:
Device: LMA (Laryngeal Mask Airway)

Trial contacts and locations

1

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Central trial contact

Amel Hanfy Abo El-Ela, professor; Dalia Saad, ass prof

Data sourced from clinicaltrials.gov

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