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).
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
- Conditions the study is for
- Pulmonary Atelectasis, Mechanical Ventilation Complication, General Anesthesia
- 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.
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.
- Conditions
- Pulmonary Atelectasis, Mechanical Ventilation Complication, General Anesthesia, Lung Ultrasound
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Pressure controlled ventilation (PCV) mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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)
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
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
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
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.
- First posted28 May 2024
- Study start20 Mar 2024
- Primary completion10 Jun 2024
- Study completion25 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary AtelectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ahmet Aras, Ankara Etlik City Hospital
- Investigators
- Ahmet Aras, MD, Principal investigator, Republic of Türkiye Ministry of Health Ankara Etlik City Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Atelectasis Frequency in Different Ventilation Modes Used in General Anesthesia in Children With Lung Ultrasonography
- ClinicalTrials.gov ID
- NCT06430229
- Acronym / sponsor ID
- AEŞH-BADEK-2024-152
- Conditions
- Pulmonary Atelectasis, Mechanical Ventilation Complication, General Anesthesia, Lung Ultrasound
- Keywords
- Pulmonary Atelectasis, Mechanic Ventilation, General anesthesia, Lung Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients ventilated with volume controlled ventilation (VCV) mode | Active comparator | Procedure: Volume controlled ventilation (VCV) modePatients 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. |
| Patients ventilated with pressure controlled ventilation (PCV) mode | Active comparator | Procedure: Pressure controlled ventilation (PCV) modeAppropriate 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. |
Who may qualify
- Ages
- 24 to 120 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volume controlled ventilation (VCV) modePatients 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. | Procedure or surgery | Patients ventilated with volume controlled ventilation (VCV) mode |
| Pressure controlled ventilation (PCV) modeAppropriate 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. | Procedure or surgery | Patients ventilated with pressure controlled ventilation (PCV) mode |
Primary outcome
Volume-controlled ventilation (VCV ) and pressure-controlled ventilation (PCV) respiratory ventilation modes modified lung ultrasonography scores before extubation
Time frame: 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.
5 secondary outcomes
Frequency of atelectasis in volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV) respiratory ventilation modes
Time frame: Before LMA (preoperative period)
Frequency of atelectasis in volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV) respiratory ventilation modes
Time frame: 10th minute after LMA
Frequency of atelectasis in volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV) respiratory ventilation modes
Time frame: 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.
Time frame: 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.
Time frame: 10th minute after LMA, pre-extubation period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmet Aras, MD principal investigator
Republic of Türkiye Ministry of Health Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
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.