Single-step vs Stepwise Lung Recruitment Maneuvers After Cardiopulmonary Bypass
ConditionAtelectasis, Postoperative
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorOndokuz Mayıs University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-80 years
ASA (American Society of Anesthesiologists) II-IV
Patients undergoing elective cardiac surgery (coronary artery bypass grafting, mitral valve replacement, aortic valve replacement)
Disqualifiers
Emergency surgery
Presence of perioperative arrhythmia
<35% left ventricular ejection fraction
>50 mmHg systolic pulmonary artery pressure
Trial design
Design model
Parallel
Treatments tested in this trial
Single Step Lung Recruitment Maneuver
Procedure/SurgeryA 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.
Stepwise Lung Recruitment Maneuver
Procedure/SurgeryA 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.
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: Grup Single StepActive comparator 1 intervention
Group B: Grup StepwiseActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Cardiac Index
Difference in cardiac index measured before and after the lung recruitment maneuver.
Time frame
Intraoperative periodSecondary outcomes
1
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.
Time frame
Intraoperative period and postoperative day 1.2
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.
Time frame
Intraoperative period and postoperative day 1.3
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.
Time frame
Intraoperative period and postoperative day 1.4
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.
Time frame
Intraoperative period and postoperative day 1.Sponsors and contacts
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Source ClinicalTrials.gov