Volume Versus Pressure Ventilation on Lung Atelectasis

January 14, 2024 updated by: Dalia Saad Abd-El Kader, Kasr El Aini Hospital

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.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt
        • Dalia Saad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: LMA (Laryngeal Mask Airway)
Pressure controlled versus Volume controlled ventilation using LMA
Other Names:
  • Lung Ultrasound
Experimental: 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.
Device: LMA (Laryngeal Mask Airway)
Pressure controlled versus Volume controlled ventilation using LMA
Other Names:
  • Lung Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative incidence of Lung atelectasis immediate post-removal of LMA.
Time Frame: immediated post removal of LMA
calculate lung score using lung ultrasound
immediated post removal of LMA

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between lung score and PaO2 /FiO2 ratio
Time Frame: From the preoperative period (T0) to 30 minutes post-extubation
Arterial blood gases (ABG) in different time
From the preoperative period (T0) to 30 minutes post-extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasr El Aini Hospital

Investigators

  • Principal Investigator: Amel Hanfy Abo El- Ela, Kasr El Aini Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2024

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

September 27, 2023

First Submitted That Met QC Criteria

October 6, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 14, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-96-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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