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Postoperative pulmonary complications are a frequent cause of morbidity following lumbar stabilization surgery. Conventional ventilation strategies may not adequately reflect intraoperative changes in respiratory mechanics, potentially leading to impaired postoperative pulmonary function. Dynamic compliance-guided ventilation provides a real-time, individualized approach by adjusting ventilatory parameters according to lung compliance.
This prospective randomized controlled study aims to evaluate the effects of dynamic compliance-guided ventilation compared with standard ventilation strategies on postoperative pulmonary function in patients undergoing lumbar stabilization surgery. Eligible patients will be randomly assigned to either the compliance-guided group or the conventional ventilation group.
In this study, the investigators aim to prospectively compare ventilation with the dynamic compliance (Cdyn) approach-one of the lung-protective ventilation strategies-with conventional ventilation methods in patients undergoing surgery in the prone position. The primary outcome will be evaluated using a modified lung ultrasound scoring system based on the most severely affected regions of aeration loss. Secondary objectives include the assessment of intraoperative hemodynamics, respiratory mechanics, and the effects on postoperative pulmonary function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dynamic Compliance Guided Ventilation | Active Comparator | Patients receive intraoperative ventilation adjusted according to real time dynamic compliance monitoring |
|
| Standart Ventilation | Active Comparator | Patients receive intraoperative ventilation based on conventional standart settings without dynamic compliance adjustment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynamic Compliance Guided Ventilation | Procedure | After intubation and prone positioning, both groups will undergo the same initial recruitment maneuver as described above. In the dynamic compliance-guided group, positive end expiratory pressure(PEEP) will then be titrated according to dynamic compliance (Cdyn = VT / [Ppeak - PEEP])(Ppeak: Peak airway pressure)(VT:Tidal volume). Tidal volume will be set at 7 ml/kg, respiratory rate 12/min, and positive end expiratory pressure(PEEP) reduced stepwise from 20 cmH₂O to 5 cmH₂O in increments of 2 cmH₂O. Each positive end expiratory pressure(PEEP) level (19, 17, 15, 13, 11, 9, 7, 5 cmH₂O) will be maintained for 10 respiratory cycles, with Cdyn measured at the end of each level. The positive end expiratory pressure(PEEP) corresponding to the highest dynamic compliance will be selected and maintained throughout the surgery.In both groups, a 30% t-pause will be applied throughout the operation after intubation. Patients will be ventilated in volume-controlled ventilation (VCV) mode. |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Lung Ultrasound Score | The assessment will be performed using the Modified Lung Ultrasound Scoring system. The scale ranges from a minimum of 0 to a maximum of 36 points. A score of 0 indicates normal aeration in all zones, while a score of 36 represents the worst possible aeration loss. Higher scores indicate a worse outcome (increased lung aeration loss/atelectasis). | baseline, postoperative 1th hour, postoperative 24th hour |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence postoperative pulmonary complications(PPC) | Number of participants with at least one postoperative pulmonary complication (including atelectasis, pneumonia, bronchospasm, hypoxemia, or reintubation) within the first 7 days after surgery. Percentage of participants | postoperative first 7 days |
| Intraoperative Dynamic Compliance (Cdyn) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Bilkent City Hospital | Ankara | 06800 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38460413 | Background | Bao C, Cao H, Shen Z, Hu Y, Huang J, Shu Q, Chen Q. Comparison of volume-controlled ventilation, pressure-controlled ventilation and pressure-controlled ventilation-volume guaranteed in infants and young children in the prone position: A prospective randomized study. J Clin Anesth. 2024 Aug;95:111440. doi: 10.1016/j.jclinane.2024.111440. Epub 2024 Mar 8. | |
| 31306184 |
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| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| D055397 | Ventilator-Induced Lung Injury |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
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|
| Standard Ventilation | Procedure | After intubation, both groups will initially receive conventional ventilation in volume-controlled mode with a tidal volume of 7 ml/kg (predicted body weight), positive end expiratory pressure(PEEP) of 5 cmH₂O, and an inspiratory-to-expiratory ratio of 1:2. Respiratory rate will be adjusted to maintain end-tidal CO₂ between 35-45 mmHg. Following prone positioning, a recruitment maneuver will be performed using pressure-controlled ventilation, gradually increasing positive end expiratory pressure(PEEP) from 5 to 20 cmH₂O and holding for 20 seconds. After recruitment, the standard ventilation group will continue with the initial ventilator settings until the end of the surgery. Patients will be ventilated in volume-controlled ventilation (VCV) mode. |
|
Mean dynamic respiratory compliance measured during the intraoperative period. Unit of Measure: mL/cmH2O |
| intraoperative |
| Intraoperative Plateau Pressure (Pplat) | Mean airway plateau pressure measured during the intraoperative period. Unit of Measure: cmH2O | intraoperative |
| Intraoperative Driving Pressure (ΔP) | Mean airway Driving Pressure measured during the intraoperative period. Unit of Measure: cmH2O | intraoperative |
| Intraoperative Peak Pressure (Ppeak) | Mean airway Peak Pressure measured during the intraoperative period. Unit of Measure: cmH2O | intraoperative |
| Mean arterial pressure(MAP) | Mean arterial pressure(MAP) | Baseline,intraoperative,1st hour postoperatively. |
| Heart Rate | Heart Rate | Baseline,intraoperative,1st hour postoperatively. |
| Length of stay | Hospitalization duration | From date of surgery until date of hospital discharge |
| Partial pressure of oxygen | arterial blood oxygen partial pressure | Baseline, intraoperative,1st hour postoperatively. |
| SPO2 | Measurement of non invasive oxygen saturation | Baseline,intraoperative,1st hour postoperatively. |
| Chun EH, Baik HJ, Moon HS, Jeong K. Comparison of low and high positive end-expiratory pressure during low tidal volume ventilation in robotic gynaecological surgical patients using electrical impedance tomography: A randomised controlled trial. Eur J Anaesthesiol. 2019 Sep;36(9):641-648. doi: 10.1097/EJA.0000000000001047. |
| 32388650 | Background | Ruszkai Z, Kiss E, Laszlo I, Bokretas GP, Vizseralek D, Vamossy I, Surany E, Buzogany I, Bajory Z, Molnar Z. Effects of intraoperative positive end-expiratory pressure optimization on respiratory mechanics and the inflammatory response: a randomized controlled trial. J Clin Monit Comput. 2021 May;35(3):469-482. doi: 10.1007/s10877-020-00519-6. Epub 2020 May 9. |
| 37679285 | Background | Kim YJ, Kim BR, Kim HW, Jung JY, Cho HY, Seo JH, Kim WH, Kim HS, Hwangbo S, Yoon HK. Effect of driving pressure-guided positive end-expiratory pressure on postoperative pulmonary complications in patients undergoing laparoscopic or robotic surgery: a randomised controlled trial. Br J Anaesth. 2023 Nov;131(5):955-965. doi: 10.1016/j.bja.2023.08.007. Epub 2023 Sep 9. |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |