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Atelectasis, Postoperative PulmonaryNCT07413575

Evaluation of the Effects of Intraoperative Ventilation Modes on Perioperative Atelectasis

An observational study of Atelectasis, Postoperative Pulmonary, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research 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

In hysterectomy surgeries, due to factors such as the abdominal nature of the procedure, prolonged operative duration, and the use of the head-down (Trendelenburg) position during surgery, a lobe or a specific region of the lungs may collapse and fail to fill with air in the postoperative period. Read more about this study

Who is it for?
Ages 45 years and older, women only
Conditions the study is for
Atelectasis, Postoperative Pulmonary
How many people
78 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Sep 2024to 5 Aug 2025
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 45 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients meet eligibility criteria and will undergone histerectomy surgery from 15/09/2024 to 15/09/2025 in Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Who may be able to join

  • Patients aged 45 years and older scheduled for hysterectomy surgery with an expected operative duration of more than 2 hours
  • Patients classified as American Society of Anesthesiologists (ASA) Physical Status Class I, II, or III
  • Patients for whom planned total intravenous anesthesia was preferred

Who cannot join

  • Patients younger than 45 years
  • Patients planned for postoperative intensive care unit monitoring
  • Patients unable to provide written informed consent
  • Patients classified as American Society of Anesthesiologists Physical Status Class IV or higher
  • Patients with a body mass index (BMI) greater than 35
  • Patients who did not consent to participate in the study
Show all 14Show fewer
  • Patients with neuromuscular diseases
  • Patients with uncontrolled asthma
  • Patients with chronic obstructive pulmonary disease (COPD), Global Initiative for Chronic Obstructive Lung Disease (GOLD) Class IV
  • Patients with scoliosis
  • Patients with a history of pulmonary resection
  • Patients with chest wall deformities
  • Patients with a history of spontaneous pneumothorax
  • Patients for whom inhalational anesthesia was preferred

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

    Sancaktepe, Istanbul, 34785

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Effects of Intraoperative Ventilation Modes on Perioperative Atelectasis in Patients Undergoing Hysterectomy by Lung Ultrasonography

In hysterectomy surgeries, due to factors such as the abdominal nature of the procedure, prolonged operative duration, and the use of the head-down (Trendelenburg) position during surgery, a lobe or a specific region of the lungs may collapse and fail to fill with air in the postoperative period. This condition is referred to as atelectasis.

In this study, the investigators aimed to evaluate the effects of ventilation modes used in the operating room on the development of postoperative atelectasis using lung ultrasonography.

Read the detailed description

Postoperative pulmonary complications (such as atelectasis, pneumonia, pulmonary embolism, pleural effusion, pulmonary edema, and pneumothorax) are clinically significant because hospital stay is prolonged and morbidity and mortality are increased. Atelectasis is one of the most common respiratory complications in the perioperative period and occurs in 80-100% of patients undergoing general anesthesia. Anesthesia may lead to alveolar inhomogeneity, and the use of positive pressure ventilation may cause lung injury through mechanisms such as atelectotrauma, barotrauma, and biotrauma. Therefore, identifying the relationship between routine perioperative practices and the development of atelectasis may help guide the development of preventive strategies. Ventilator-induced lung injury (VILI) arises from the interaction between the energy delivered by the ventilator to the lung tissue and the tissue's response to this energy. Ventilator-associated lung injury occurring in patients receiving mechanical ventilation significantly increases morbidity and mortality. In recent years, numerous studies have focused on improving standard ventilation strategies-such as reducing tidal volume and adjusting positive end-expiratory pressure (PEEP)-to reduce the risk of VILI. However, VILI rates remain high and continue to contribute to postoperative pulmonary complications as well as complications in intensive care patients. One of the principal challenges of mechanical ventilation is the inability to accurately assess patient-specific lung mechanics using routinely monitored parameters. The lung characteristics predisposing to VILI are particularly dependent on the degree of pulmonary edema. Edema promotes atelectasis, increases inhomogeneity, elevates mechanical stress, and leads to cyclic opening and closing of alveoli. Ventilator-induced lung injury results from the interaction between mechanical power and the ventilated lung parenchyma. Tidal volume, ΔPaw (difference in plateau airway pressure), peak airway pressure, respiratory rate (RR), flow rate, and positive end-expiratory pressure (PEEP) are components of this interaction, each contributing to mechanical power in different ways. Factors affecting the development of atelectasis include the type, location, and duration of surgery, as well as patient positioning. Hysterectomy procedures are considered a high-risk group for postoperative atelectasis because they involve abdominal surgery, prolonged operative times, and the use of the Trendelenburg position. Anesthesia-related atelectasis is often too small to be detected on conventional chest radiographs. Comparative studies using computed tomography (CT) or magnetic resonance imaging (MRI) have demonstrated that lung ultrasonography can reliably detect anesthesia-related atelectasis with approximately 90% sensitivity, specificity, and diagnostic accuracy. Lung ultrasonography is therefore recommended for the diagnosis of anesthesia-related atelectasis and for monitoring respiratory complications. Flow-controlled ventilation (FCV) is a ventilation mode in which a constant low flow is applied during both inspiration and expiration. In this technique, airway pressure increases linearly during inspiration and decreases linearly during expiration. The applied flow is adjusted to maintain normocapnia (normal arterial carbon dioxide levels), and the inspiration-to-expiration (I:E) ratio is set at 1:1. This technique represents an innovative approach in mechanical ventilation. With constant flow and direct measurement of tracheal pressure, individualized lung mechanics can be assessed, which is not possible with conventional ventilation modes in which flow is variable and tracheal pressure cannot be directly monitored. Flow-controlled ventilation allows accurate calculation of dynamic compliance, enabling precise adjustment of positive end-expiratory pressure and peak inspiratory pressure (Ppeak). Thus, ventilation can be delivered within the lower and upper inflection points of the pressure-volume curve, tailored to individual lung mechanics. In pressure-controlled ventilation (PCV), peak airway pressure is controlled, and mandatory respiratory rate and inspiratory time are set. Once the preset pressure is reached, gas flow ceases; however, expiration does not begin until the preset inspiratory time has elapsed. In volume-controlled ventilation (VCV), a fixed tidal volume is delivered using a user-defined flow rate and inspiratory time. Airway pressure may vary, and excessive pressure may lead to barotrauma. In this study, the investigators aimed to evaluate the effects of flow-controlled ventilation, volume-controlled ventilation, and pressure-controlled ventilation modes used in the operating room on the development of postoperative atelectasis using lung ultrasonography. Following approval numbered 2024/241 by the Scientific Research Ethics Committee of Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital, patients scheduled for elective hysterectomy who met the inclusion criteria were screened. Patients who provided written informed consent after receiving detailed information about the study were included. Age, American Society of Anesthesiologists Physical Status Classification (ASA score), body mass index (BMI), and duration of surgery were recorded. Due to the observational nature of the study, lung ultrasonographic evaluation-considered a routine component of the pre-anesthesia assessment in the clinic-was performed, and lung ultrasound scores were recorded. After each participant was positioned on the operating table, standard anesthesia monitoring was applied, including heart rate (HR), electrocardiography (ECG), noninvasive arterial blood pressure monitoring, mean arterial pressure (MAP), peripheral oxygen saturation (SpO₂), and processed electroencephalography measured by the bispectral index (BIS). These parameters were recorded. Adequate surgical depth of anesthesia was achieved using propofol-remifentanil infusion guided by processed electroencephalography monitoring. After induction and adjustment of the mechanical ventilator by the responsible anesthesiologist, the observer recorded vital signs (SpO₂, HR, arterial pressure, processed electroencephalography), ventilation mode, peak airway pressure (Ppeak), positive end-expiratory pressure, plateau pressure, tidal volume, respiratory rate (f), end-tidal carbon dioxide (EtCO₂), fraction of inspired oxygen (FiO₂), flow rate, and inspiration-to-expiration ratio. Measurements were recorded at the following time points: preoperatively, after induction, before and after pneumoperitoneum, before and after positioning, and at 30-minute intervals thereafter. Arterial blood gas analysis was performed preoperatively and in the post-anesthesia care unit (PACU). Using vital signs, blood gas analysis, and mechanical ventilator parameters, heart rate, mean arterial pressure, peripheral oxygen saturation (SpO₂), mechanical power, lung compliance, end-tidal carbon dioxide (EtCO₂), partial pressure of carbon dioxide (pCO₂), partial pressure of oxygen (pO₂), the ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO₂/FiO₂ ratio), bispectral index (BIS), and intra-abdominal pressure were evaluated. For postoperative analgesia, techniques and medications selected by the responsible anesthesiologist, including intravenous drugs and neuraxial techniques, were recorded. In accordance with routine clinical practice, patients were transferred from the post-anesthesia care unit to the ward when the Visual Analog Scale (VAS) score was ≤3 and the Modified Aldrete Score was ≥9. Lung ultrasonographic evaluations were performed at the time of transfer and at postoperative 2 and 24 hours. Changes in lung ultrasound scores relative to preoperative values were assessed. Pain scores were recorded using the Visual Analog Scale at postoperative 2, 6, 12, and 24 hours. The statistical power of the study was expressed as 1-β (β = type II error probability), and a power of 80% was considered adequate. To achieve 80% power at a significance level of α = 0.05, a minimum of 22 patients per group (66 patients in total) was required. Considering the possibility of data loss, the study was planned to include 78 patients.

Keywords
Flow-Controlled Ventilation (FCV), Volume-Controlled Ventilation (VCV), Pressure-Controlled Ventilation (PCV), Perioperative atelectasis, Lung ultrasonography, mechanical power, oxygenation, lung ultrasound score
Medical subject headings
Pulmonary Atelectasis

What participants receive

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

Study groups in NCT07413575
Study groupRoleWhat they receive
Flow-Controlled Ventilation (FCV)Patients were divided into three groups according to the type of ventilation used. The group that received flow-controlled ventilation was designated as the FCV group. In the FCV group, a constant flow is applied during both inspiration and expiration. In all three groups, lung ultrasonographic evaluation was performed preoperatively and up to 24 hours postoperatively, and the lung ultrasound scores were determined. Vital signs, ventilation parameters, blood gas analysis, and pain scores were also recorded at specific time intervals.
Pressure-Controlled Ventilation (PCV)Patients were divided into three groups according to the type of ventilation used. The group that received pressure-controlled ventilation was designated as the PCV group. In the PCV group, the peak airway pressure is controlled. The mandatory respiratory rate and inspiratory time are also adjusted. In all three groups, lung ultrasonographic evaluation was performed preoperatively and up to 24 hours postoperatively, and the lung ultrasound scores were determined. Vital signs, ventilation parameters, blood gas analysis, and pain scores were also recorded at specific time intervals.
Volume-Controlled Ventilation (VCV)Patients were divided into three groups according to the ventilation mode used. The group receiving volume-controlled ventilation (VCV) was designated as the VCV group. In the VCV group, a specific tidal volume (Vt) was achieved by maintaining a constant flow rate and inspiratory time set on the ventilator, while airway pressure was allowed to vary. In all three groups, lung ultrasonographic evaluation was performed preoperatively and up to 24 hours postoperatively, and lung ultrasound scores were determined. Vital signs, ventilation parameters, blood gas analysis results, and pain scores were recorded at predefined time intervals.

What is being measured

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

  1. Change in Lung Ultrasound Score (ΔLUS) From Preoperative Baseline to 24 Hours Postoperatively

    Perioperative atelectasis was assessed as the change in Lung Ultrasound Score (ΔLUS) from preoperative baseline to 24 hours postoperatively. Lung aeration was evaluated using a standardized 12-region scoring system (0-36 scores on a scale). ΔLUS was calculated as postoperative LUS at 24 hours minus preoperative baseline LUS. Higher values indicate greater loss of aeration.

    Measured: Preoperative baseline and 24 hours postoperatively

Secondary outcomes (3)
  1. Mechanical Power During Intraoperative Ventilation

    Mechanical power calculated from ventilator parameters at predefined intraoperative time points.

    Measured: Intraoperative period

  2. Arterial Oxygen Partial Pressure (PaO₂)

    PaO₂ measured by arterial blood gas analysis at preoperative baseline and at the time of discharge from the Post-Anesthesia Care Unit (PACU).

    Measured: Preoperative and at the time of transfer from the Post-Anesthesia Care Unit (PACU) to the ward (PACU discharge).

  3. PaO₂/FiO₂ Ratio

    PaO₂/FiO₂ ratio was calculated from arterial blood gas analysis using PaO₂ and the fraction of inspired oxygen (FiO₂) at preoperative baseline and at the time of discharge from the Post-Anesthesia Care Unit (PACU).

    Measured: Preoperative and at the time of transfer from the Post-Anesthesia Care Unit (PACU) to the ward (PACU discharge).

Timeline

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

  1. First posted17 Feb 2026
  2. Study start15 Sep 2024
  3. Primary completion26 Jun 2025
  4. Study completion5 Aug 2025

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07413575
Sponsor's protocol ID
Ivstrh 2024/241
Status last verified
Sep 2025
First submitted
27 Nov 2025
Last updated
19 May 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We do not plan to share IPD for data security reasons.

Publications

  • Barnes T, van Asseldonk D, Enk D. Minimisation of dissipated energy in the airways during mechanical ventilation by using constant inspiratory and expiratory flows - Flow-controlled ventilation (FCV). Med Hypotheses. 2018 Dec;121:167-176. doi: 10.1016/j.mehy.2018.09.038. Epub 2018 Sep 24.

    PubMed 30396474
  • O'Gara B, Talmor D. Perioperative lung protective ventilation. BMJ. 2018 Sep 10;362:k3030. doi: 10.1136/bmj.k3030.

    PubMed 30201797
  • Beitler JR, Malhotra A, Thompson BT. Ventilator-induced Lung Injury. Clin Chest Med. 2016 Dec;37(4):633-646. doi: 10.1016/j.ccm.2016.07.004. Epub 2016 Oct 14.

    PubMed 27842744
  • Cressoni M, Gotti M, Chiurazzi C, Massari D, Algieri I, Amini M, Cammaroto A, Brioni M, Montaruli C, Nikolla K, Guanziroli M, Dondossola D, Gatti S, Valerio V, Vergani GL, Pugni P, Cadringher P, Gagliano N, Gattinoni L. Mechanical Power and Development of Ventilator-induced Lung Injury. Anesthesiology. 2016 May;124(5):1100-8. doi: 10.1097/ALN.0000000000001056.

    PubMed 26872367
  • Gertler R. Respiratory Mechanics. Anesthesiol Clin. 2021 Sep;39(3):415-440. doi: 10.1016/j.anclin.2021.04.003.

    PubMed 34392877
  • Gattinoni L, Pelosi P, Crotti S, Valenza F. Effects of positive end-expiratory pressure on regional distribution of tidal volume and recruitment in adult respiratory distress syndrome. Am J Respir Crit Care Med. 1995 Jun;151(6):1807-14. doi: 10.1164/ajrccm.151.6.7767524.

    PubMed 7767524
  • Protti A, Maraffi T, Milesi M, Votta E, Santini A, Pugni P, Andreis DT, Nicosia F, Zannin E, Gatti S, Vaira V, Ferrero S, Gattinoni L. Role of Strain Rate in the Pathogenesis of Ventilator-Induced Lung Edema. Crit Care Med. 2016 Sep;44(9):e838-45. doi: 10.1097/CCM.0000000000001718.

    PubMed 27054894
  • Mazo V, Sabate S, Canet J, Gallart L, de Abreu MG, Belda J, Langeron O, Hoeft A, Pelosi P. Prospective external validation of a predictive score for postoperative pulmonary complications. Anesthesiology. 2014 Aug;121(2):219-31. doi: 10.1097/ALN.0000000000000334.

    PubMed 24901240
  • Ball L, Hemmes SNT, Serpa Neto A, Bluth T, Canet J, Hiesmayr M, Hollmann MW, Mills GH, Vidal Melo MF, Putensen C, Schmid W, Severgnini P, Wrigge H, Gama de Abreu M, Schultz MJ, Pelosi P; LAS VEGAS investigators; PROVE Network; Clinical Trial Network of the European Society of Anaesthesiology. Intraoperative ventilation settings and their associations with postoperative pulmonary complications in obese patients. Br J Anaesth. 2018 Oct;121(4):899-908. doi: 10.1016/j.bja.2018.04.021. Epub 2018 Jun 2.

    PubMed 30236252
  • Duggan M, Kavanagh BP. Pulmonary atelectasis: a pathogenic perioperative entity. Anesthesiology. 2005 Apr;102(4):838-54. doi: 10.1097/00000542-200504000-00021.

    PubMed 15791115
  • Hedenstierna G, Edmark L. Mechanisms of atelectasis in the perioperative period. Best Pract Res Clin Anaesthesiol. 2010 Jun;24(2):157-69. doi: 10.1016/j.bpa.2009.12.002.

    PubMed 20608554

Questions about this trial

What is this clinical trial studying?

An observational study of Atelectasis, Postoperative Pulmonary, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research 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 3 inclusion and 14 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 19 May 2026. 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?

Yes. Results are posted in the registry (first posted 19 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Lung Ultrasound Score (ΔLUS) From Preoperative Baseline to 24 Hours Postoperatively (time frame: Preoperative baseline and 24 hours postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07413575, which also lists 11 linked publications.

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 19 May 2026.

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