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This prospective randomized controlled trial aims to compare the hemodynamic and pulmonary effects of single-step and stepwise lung recruitment maneuvers in adult patients undergoing elective cardiac surgery with cardiopulmonary bypass. After separation from cardiopulmonary bypass, patients will be randomized to receive either a single-step sustained inflation recruitment maneuver or a stepwise incremental recruitment maneuver, both combined with 8 cmH₂O positive end-expiratory pressure. The primary outcome is the change in cardiac index before and after the recruitment maneuver. Secondary outcomes include lung ultrasound atelectasis score, and hemodynamic parameters.
Atelectasis frequently develops after cardiopulmonary bypass due to lung ischemia-reperfusion injury, inflammatory response, and mechanical factors related to cardiac surgery. Lung recruitment maneuvers are commonly used to improve lung aeration and oxygenation; however, increased intrathoracic pressure during recruitment may negatively affect venous return and cardiac output.
In this randomized controlled trial, adult patients undergoing elective open-heart surgery with cardiopulmonary bypass will be allocated to receive either a single-step sustained inflation recruitment maneuver or a stepwise incremental recruitment maneuver, both combined with 8 cmH₂O positive end-expiratory pressure after separation from cardiopulmonary bypass. Hemodynamic variables, particularly cardiac index, will be assessed before and after recruitment. Pulmonary effects will be evaluated using lung ultrasound atelectasis scoring and arterial blood gas analysis. The study aims to identify the recruitment strategy that provides optimal pulmonary benefits while preserving hemodynamic stability in this high-risk patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Grup Single Step | Active Comparator | A single step lung recruitment maneuver for 30 seconds will be applied |
|
| Grup Stepwise | Active Comparator | A stepwise recruitment maneuver will be applied. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single Step Lung Recruitment Maneuver | Procedure | A sustained inflation lung recruitment maneuver with an airway pressure of 30 cmH₂O applied for 30 seconds after separation from cardiopulmonary bypass, combined with 8 cmH₂O positive end-expiratory pressure. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cardiac Index | Difference in cardiac index measured before and after the lung recruitment maneuver. | Intraoperative period |
| Measure | Description | Time Frame |
|---|---|---|
| The heart rate measurement | Heart rate will be recorded preoperatively; after induction; immediately before the recruitment maneuver (RM); during RM at the point of maximum airway pressure; at the end of RM; 30 minutes after RM; at postoperative hour 1; and immediately after extubation. | Intraoperative period and postoperative day 1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Burhan Dost, MD | Contact | +903623121919 | burhandost@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ondokuz Mayıs University, Faculty of Medicine | Recruiting | Samsun | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27861261 | Background | Longo S, Siri J, Acosta C, Palencia A, Echegaray A, Chiotti I, Parisi A, Ricci L, Natal M, Suarez-Sipmann F, Tusman G. Lung recruitment improves right ventricular performance after cardiopulmonary bypass: A randomised controlled trial. Eur J Anaesthesiol. 2017 Feb;34(2):66-74. doi: 10.1097/EJA.0000000000000559. | |
| 17242096 | Background |
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| ID | Term |
|---|---|
| D001261 | Pulmonary Atelectasis |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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Participants will be randomized in a 1:1 ratio to receive either a single-step sustained inflation lung recruitment maneuver or a stepwise incremental lung recruitment maneuver after separation from cardiopulmonary bypass.
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Both the patients and the clinicians involved in perioperative management are blinded to group allocation. Outcome assessment and data analysis are performed by an investigator who is also blinded to group assignment.
| Stepwise Lung Recruitment Maneuver | Procedure | A stepwise lung recruitment maneuver in which airway pressure is increased by 5 cmH₂O every 5 seconds up to 30 cmH₂O and then decreased in the same manner after separation from cardiopulmonary bypass, combined with 8 cmH₂O positive end-expiratory pressure. |
|
| The mean arterial pressure measurement |
Mean arterial pressure will be recorded preoperatively; after induction; immediately before the recruitment maneuver (RM); during RM at the point of maximum airway pressure; at the end of RM; 30 minutes after RM; at postoperative hour 1; and immediately after extubation. |
| Intraoperative period and postoperative day 1. |
| Systemic vascular resistance index measurement | Systemic vascular resistance index will be recorded preoperatively; after induction; immediately before the recruitment maneuver (RM); during RM at the point of maximum airway pressure; at the end of RM; 30 minutes after RM; at postoperative hour 1; and immediately after extubation. | Intraoperative period and postoperative day 1. |
| Stroke volume variation | Dynamic hemodynamic parameters, including stroke volume variation (SVV, %), will be recorded as separate variables using invasive arterial waveform analysis. Measurements will be obtained after induction; immediately before the recruitment maneuver (RM); during RM at the point of maximum airway pressure; at the end of RM; 30 minutes after RM; at postoperative hour 1; and immediately after extubation. | Intraoperative period and postoperative day 1. |
| Arterial elastance | Dynamic hemodynamic parameters including arterial elastance (Ea, mmHg/mL), will be recorded as separate variables using invasive arterial waveform analysis. Measurements will be obtained after induction; immediately before the recruitment maneuver (RM); during RM at the point of maximum airway pressure; at the end of RM; 30 minutes after RM; at postoperative hour 1; and immediately after extubation. | Intraoperative period and postoperative day 1. |
| Contractility | Dynamic hemodynamic parameters, including cardiac contractility indices, will be recorded as separate variables using invasive arterial waveform analysis. Measurements will be obtained after induction; immediately before the recruitment maneuver (RM); during RM at the point of maximum airway pressure; at the end of RM; 30 minutes after RM; at postoperative hour 1; and immediately after extubation. | Intraoperative period and postoperative day 1. |
| Lung ultrasound atelectasis score | Change in lung ultrasound atelectasis score before and after the recruitment maneuver. Lung aeration was assessed using a 12-region quantitative lung ultrasound (LUS) score (0-36) based on the ESICM-ESPNIC consensus. Each region was graded 0-3 (0 = normal aeration; 1 = mild loss with B-lines/subpleural changes ≤50%; 2 = moderate loss with coalescent B-lines or small consolidation <2-2.5 cm; 3 = severe loss with large consolidation ≥2-2.5 cm). Higher scores indicated greater aeration loss. | Intraoperative period and postoperative day 1 |
| Peak airway pressure | Peak airway pressure (Ppeak), measured in cmH₂O, will be recorded after induction; immediately before the recruitment maneuver (RM); during RM at the point of maximum airway pressure; at the end of RM; 30 minutes after RM; at postoperative hour 1; and immediately after extubation. | Intraoperative period and postoperative day 1. |
| Plateau pressure | plateau pressure (Pplat), measured in cmH₂O, will be recorded after induction; immediately before the recruitment maneuver (RM); during RM at the point of maximum airway pressure; at the end of RM; 30 minutes after RM; at postoperative hour 1; and immediately after extubation. | Intraoperative period and postoperative day 1. |
| Dynamic lung compliance | Dynamic lung compliance (Cdyn), expressed as mL/cmH₂O, will be recorded after induction; immediately before the recruitment maneuver (RM); during RM at the point of maximum airway pressure; at the end of RM; 30 minutes after RM; at postoperative hour 1; and immediately after extubation. | Intraoperative period and postoperative day 1. |
| Driving pressure | Driving pressure, calculated as plateau pressure minus positive end-expiratory pressure (Pplat - PEEP) and expressed in cmH₂O, will be recorded after induction; immediately before the recruitment maneuver (RM); during RM at the point of maximum airway pressure; at the end of RM; 30 minutes after RM; at postoperative hour 1; and immediately after extubation. | Intraoperative period and postoperative day 1. |
| Positive end-expiratory pressure | Positive end-expiratory pressure (PEEP), measured in cmH₂O, will be recorded after induction; immediately before the recruitment maneuver (RM); during RM at the point of maximum airway pressure; at the end of RM; 30 minutes after RM; at postoperative hour 1; and immediately after extubation. | Intraoperative period and postoperative day 1. |
| Arterial pH | Arterial pH (unitless) measured by arterial blood gas analysis will be recorded after induction; immediately before the recruitment maneuver (RM); during RM at the point of maximum airway pressure; at the end of RM; 30 minutes after RM; at postoperative hour 1; and immediately after extubation. | Intraoperative period and postoperative day 1. |
| Partial pressure of arterial oxygen | Partial pressure of arterial oxygen (PaO₂, mmHg) measured by arterial blood gas analysis will be recorded after induction; immediately before the recruitment maneuver (RM); during RM at the point of maximum airway pressure; at the end of RM; 30 minutes after RM; at postoperative hour 1; and immediately after extubation. | Intraoperative period and postoperative day 1. |
| Partial pressure of arterial carbon dioxide | Partial pressure of arterial carbon dioxide (PaCO₂, mmHg) measured by arterial blood gas analysis will be recorded after induction; immediately before the recruitment maneuver (RM); during RM at the point of maximum airway pressure; at the end of RM; 30 minutes after RM; at postoperative hour 1; and immediately after extubation. | Intraoperative period and postoperative day 1. |
| Serum lactate level | Change in serum lactate level measured perioperatively. | Intraoperative period and postoperative day 1 |
| Extubation time | After the operation, the time until the patient is extubated will be recorded. | Postoperative day 1 |
| Length of intensive care unit stay (ICU) | Time from ICU admission to ICU discharge. | The time from admission to the ICU to the time of discharge to the hospital ward; during the hospital stay, an average of 7 days |
| Celebi S, Koner O, Menda F, Korkut K, Suzer K, Cakar N. The pulmonary and hemodynamic effects of two different recruitment maneuvers after cardiac surgery. Anesth Analg. 2007 Feb;104(2):384-90. doi: 10.1213/01.ane.0000252967.33414.44. |
| 31920224 | Background | Myatra SN. Hemodynamic effects of alveolar recruitment maneuvres in the operating room: Proceed with caution. J Anaesthesiol Clin Pharmacol. 2019 Oct-Dec;35(4):431-433. doi: 10.4103/joacp.JOACP_223_19. No abstract available. |
| 16096751 | Background | Nielsen J, Ostergaard M, Kjaergaard J, Tingleff J, Berthelsen PG, Nygard E, Larsson A. Lung recruitment maneuver depresses central hemodynamics in patients following cardiac surgery. Intensive Care Med. 2005 Sep;31(9):1189-94. doi: 10.1007/s00134-005-2732-z. Epub 2005 Aug 12. |
| 40353867 | Background | Mongodi S, Cortegiani A, Alonso-Ojembarrena A, Biasucci DG, Bos LDJ, Bouhemad B, Cantinotti M, Ciuca I, Corradi F, Girard M, Gregorio-Hernandez R, Gualano MR, Mojoli F, Ntoumenopoulos G, Pisani L, Raimondi F, Rodriguez-Fanjul J, Savoia M, Smit MR, Tuinman PR, Zieleskiewicz L, De Luca D. ESICM-ESPNIC international expert consensus on quantitative lung ultrasound in intensive care. Intensive Care Med. 2025 Jun;51(6):1022-1049. doi: 10.1007/s00134-025-07932-y. Epub 2025 May 12. |