NCT06430229

Brief Summary

General anesthesia is characterized by temporary loss of consciousness and decreased reflex activity without any change in vital functions. It can be performed with intravenous and/or inhalation agents. During general anesthesia, breathing is stopped and respiratory support is provided to patients with various respiratory equipment and ventilation modes on the anesthesia device. The most commonly used ventilation modes during anesthesia are volume controlled (VCV) and pressure controlled (PCV). In pressure-controlled ventilation, ventilation is provided with the airway pressure determined by the anesthesiologist throughout inspiration. While the pressure is constant during inspiration, the tidal volume is variable. In volume controlled ventilation, ventilation executed at the volume is set by the anesthesiologist. In other words, the determined volume is constant, but airway pressures vary. In pediatric anesthesia practice modes have not been shown to have a clear advantage over each other. Both modes have advantages and disadvantages. With the development of modern anesthesia devices in recent years, safe ventilation can be provided even in very young children with volume controlled mode (VCV). Atelectasis is the restriction of gas exchange due to complete or partial collapse of the lung. Atelectasis can be seen in 90 percent of patients receiving general anesthesia. This incidence is reported to be 68-100 percent in children. Lung ultrasonography is an imaging method with many advantages for imaging lung-related diseases, such as not containing ionizing radiation, being inexpensive, and being performed at the bedside. Recently, its use by anesthesiologists has become widespread in many lung pathologies, including atelectasis. Traditional and modified lung ultrasonography scoring systems can be used to evaluate atelectasis in lung parenchyma with ultrasonography. In addition to the traditional system, modified scoring system also enables to evaluate small subpleural consolidations In this study, it was aimed to compare the effects of volume controlled and pressure controlled ventilation modes used in general anesthesia in children on atelectasis with lung ultrasonography.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 28, 2024

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2024

Completed
Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

May 9, 2024

Last Update Submit

December 17, 2025

Conditions

Keywords

Pulmonary AtelectasisMechanic VentilationGeneral anesthesiaLung Ultrasound

Outcome Measures

Primary Outcomes (1)

  • Volume-controlled ventilation (VCV ) and pressure-controlled ventilation (PCV) respiratory ventilation modes modified lung ultrasonography scores before extubation

    Comparison of the total modified lung ultrasonography score of 12 quadrants (0-36 points) before extubation between groups in terms of atelectasis. An increase in the USG score indicates an increase in the severity of atelectasis. A decrease in the USG score indicates that the severity of atelectasis is low.

    Before extubation

Secondary Outcomes (5)

  • Frequency of atelectasis in volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV) respiratory ventilation modes

    Before LMA (preoperative period)

  • Frequency of atelectasis in volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV) respiratory ventilation modes

    10th minute after LMA

  • Frequency of atelectasis in volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV) respiratory ventilation modes

    10th minute after extubation

  • Comparison of atelectasis incidence and modified Lung ultrasonography (USG) scores (0-3 points) in 12 different lung regions of patients followed in VCV/PCV ventilation modes under general anesthesia.

    pre-LMA period (preoperative period), 10th minute after LMA, pre-extubation period, 10th minute after extubation

  • The effects of these ventilation modes on lung pressures parameters.

    10th minute after LMA, pre-extubation period

Study Arms (2)

Patients ventilated with volume controlled ventilation (VCV) mode

ACTIVE COMPARATOR

Patients to be ventilated with VCV mode were placed on respiratory support (Dräger Primus) with a breathing rate that would provide 8 ml/kg tidal volume, 5 cmH2O positive end expiratory pressure (PEEP), and 30-35 mmHg end-tidal carbon dioxide concentration (etCO2) level.

Procedure: Volume controlled ventilation (VCV) mode

Patients ventilated with pressure controlled ventilation (PCV) mode

ACTIVE COMPARATOR

Appropriate peak inspiratory pressure was set to create a tidal volume of 8 ml/kg in patients who would be ventilated with PCV mode. The number of breaths (Dräger Primus) was adjusted to provide an end-tidal carbon dioxide concentration (etCO2) level of 30-35 mmHg. PEEP was set to 5 cmH2O.

Procedure: Pressure controlled ventilation (PCV) mode

Interventions

Patients to be ventilated with VCV mode were placed on respiratory support (Dräger Primus) with a breathing rate that would provide 8 ml/kg tidal volume, 5 cmH2O PEEP, and 30-35 mmHg end-tidal carbon dioxide concentration (etCO2) level. Lung ultrasonography was performed at 4 different time periods (before laryngeal mask airway (LMA), at the 10th minute after LMA, before extubation and at the 10th minute after extubation). Modified lung ultrasonography scores of 12 quadrants were recorded.

Patients ventilated with volume controlled ventilation (VCV) mode

Appropriate peak inspiratory pressure was set to create a tidal volume of 8 ml/kg in patients who would be ventilated with PCV mode. The number of breaths (Dräger Primus) was adjusted to provide an end-tidal carbon dioxide concentration (etCO2) level of 30-35 mmHg. PEEP was set to 5 cmH2O. Lung ultrasonography was performed at 4 different time periods (before laryngeal mask airway (LMA), at the 10th minute after LMA, before extubation and at the 10th minute after extubation). Modified lung ultrasonography scores of 12 quadrants were recorded.

Patients ventilated with pressure controlled ventilation (PCV) mode

Eligibility Criteria

Age24 Months - 120 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Aged between 2 and 10 years old
  • American Society of Anesthesiologists (ASA) Scoring I-II
  • Elective surgery planned
  • Cases that will undergo general anesthesia
  • Surgical time is expected to be \>30 minutes

You may not qualify if:

  • Patients who are allergic to ultrasonography (USG) gel
  • Known obstructive and restrictive lung disease
  • Pulmonary infection in the last 3 months
  • Having a history of surgery in the last 3 months
  • A history of multiple trauma in the last 3 months
  • Body Mass Index ≥30
  • With diaphragmatic hernia
  • Having undergone laparoscopic abdominal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmet Aras

Yenimahalle, Ankara, 06170, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Ahmet Aras, MD

    Republic of Türkiye Ministry of Health Ankara Etlik City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 9, 2024

First Posted

May 28, 2024

Study Start

March 20, 2024

Primary Completion

June 10, 2024

Study Completion

June 25, 2024

Last Updated

December 23, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations