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Pulmonary AtelectasisNCT06430229

Atelectasis Frequency in Different Ventilation Modes

A study of Pulmonary Atelectasis and Mechanical Ventilation Complication, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 24 to 120 months
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Mar 2024to 25 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 24 to 120 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ahmet Aras

    Yenimahalle, Ankara, 06170

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of Atelectasis Frequency in Different Ventilation Modes Used in General Anesthesia in Children With Lung Ultrasonography

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).

Read more

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.

Read the detailed description

Traditional and modified lung ultrasonography scoring systems can be used to evaluate atelectasis in the lung parenchyma by ultrasonography. The modified scoring system also provides the opportunity to evaluate small subpleural consolidations in addition to the traditional system.

Lung tissue is evaluated between the intercostal spaces. On ultrasound, the pleural line can usually be seen as bright white due to the acoustic impedance difference between the aerated lung tissue and the surrounding tissues. Most of the ultrasound waves are reflected from this line. Due to the constantly reflected ultrasound waves between the pleural line and the transducer, hyperechoic lines parallel to the pleural line, called A lines, can be observed in the parenchyma. Vertical hyperechoic lines emerging from the pleural line in the lung ultrasound image are defined as B lines. B lines follow perpendicular to A lines. B lines accompany the sliding movement of the lungs along with the respiratory movement.

The patient is usually evaluated while lying in the supine position. The thorax is divided into 12 quadrants when evaluated with ultrasound for atelectasis. Midsternal line, anterior axillary line, posterior axillary line form the vertical boundaries of the quadrants. Each area is divided into two parts, upper and lower, by a line passing through its midpoint. Left hemithorax anterior upper, lateral upper, posterior upper, anterior lower, lateral lower, posterior lateral; The right hemithorax consists of 12 quadrants: anterior upper, lateral upper, posterior upper, anterior lower, lateral lower, and posterior lateral. The ultrasound probe is advanced transversely and each quadrant is examined. The patient may be asked to turn slightly to the side to evaluate the posterior quadrants. The ultrasound probe is placed vertically on the ribs and the lung parenchyma seen between the intercostal spaces is evaluated. Loss of ventilation is evaluated according to the modified lung ultrasonography scoring system for each quadrant. The score is collected by evaluating 12 quadrants from 0 to 3 and a value between 0-36 is obtained. For each quadrant, 0 represents the region with no ventilation loss and 3 indicates the region with severe ventilation loss. 0 indicates normal tissue with no loss of ventilation and 2 or fewer B lines are observed. 1 indicates little loss of ventilation, 3 or more B lines or one or more subpleural consolidations separated by a normal pleural line are observed. 2 indicates moderate loss of ventilation, observed as multiple fused B lines or multiple small subpleural consolidations separated by thickened or irregular pleural lines. 3 indicates severe loss of ventilation and is observed as consolidation or subpleural consolidation larger than 1x2 cm.

Each patient underwent transthoracic lung ultrasonography a total of 4 times: before laryngeal mask airway (LMA), at the 10th minute after LMA, before extubation and at the 10th minute after extubation. In addition, data on respiratory mechanics and hemodynamic parameters were recorded twice, at the 10th minute after LMA and before extubation.

Being tested
Volume controlled ventilation (VCV) mode, Pressure controlled ventilation (PCV) mode
Keywords
Pulmonary Atelectasis, Mechanic Ventilation, General anesthesia, Lung Ultrasound
Medical subject headings
Pulmonary Atelectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Volume controlled ventilation (VCV) modeProcedure or surgery

    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.

  • Pressure controlled ventilation (PCV) modeProcedure or surgery

    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.

Study groups in NCT06430229
Study groupRoleWhat they receive
Patients ventilated with volume controlled ventilation (VCV) modeActive comparatorPatients 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.
Receives: Procedure: Volume controlled ventilation (VCV) mode
Patients ventilated with pressure controlled ventilation (PCV) modeActive comparatorAppropriate 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.
Receives: Procedure: Pressure controlled ventilation (PCV) mode

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Before extubation

Secondary outcomes (5)
  1. Frequency of atelectasis in volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV) respiratory ventilation modes

    Determining the frequency of atelectasis in all quadrants before laryngeal mask airway (LMA) (preoperative period) and comparing it between the two groups

    Measured: Before LMA (preoperative period)

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

    Determining the frequency of atelectasis in all quadrants in the 10th minute after LMA and comparing it between the two groups

    Measured: 10th minute after LMA

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

    Determining the frequency of atelectasis in all quadrants in the 10th minute after extubation and comparing it between the two groups

    Measured: 10th minute after extubation

  4. 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.

    The frequency of atelectasis in all lung quadrants in the pre-LMA period, at the 10th minute after LMA, in the pre-extubation period, and at the 10th minute after extubation will be determined and compared.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.

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

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

    Effect of different ventilation modes on lung pressures (peak pressure cmH2O, plat pressure cmH2O, and mean pressure cmH2O parameters.

    Measured: 10th minute after LMA, pre-extubation period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2024
  2. Study start20 Mar 2024
  3. Primary completion10 Jun 2024
  4. Study completion25 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06430229
Sponsor's protocol ID
AEŞH-BADEK-2024-152
Status last verified
Dec 2025
First submitted
9 May 2024
Last updated
23 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study of Pulmonary Atelectasis and Mechanical Ventilation Complication, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Volume-controlled ventilation (VCV ) and pressure-controlled ventilation (PCV) respiratory ventilation modes modified lung ultrasonography scores before extubation (time frame: Before extubation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.

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