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Brief summary The goal of this clinical trial is to compare two different types of perioperative mechanical ventilation (MV), specifically Protective Mechanical Ventilation (PMV) and MV with the lowest possible Driving Pressure (ΔP), in relation to the appearance of postoperative lung closing, eg atelectasis, in adult patients who are operated. Atelectasis will be evaluated via lung ultrasound.
The main questions it aims to answer are:
Researchers will use lung ultrasound to compare MV with the lowest possible Driving Pressure (ΔP) to Protective Mechanical Ventilation (PMV) to see if any of this is more protective than the other concerning lung atelectasis.
All participants will receive perioperative MV.
Half of them will receive conventional Protective Mechanical Ventilation (PMV). This will include well known generally protective settings for mechanical ventilation of patients, concerning volumes, pressures, respiratory rate, inspiratory gases and ventilation maneuvers.
The rest of participants will be ventilated with the lowest possible Driving Pressure (ΔP). This will be similar to PMV in the chosen volumes, respiratory rate, inspiratory gases and ventilation maneuvers. However, the pressure inside lung at the end of expiration, eg Positive End Expiratory Pressure (PEEP), will be not be preset for every patient. Initially, we will perform a maneuver that will quantify each individual's lung characteristics and mechanics. According to this, we will find the exact PEEP that seems to suit each patients lungs most, and use this perioperatively, trying to provide lungs the best conditions every time.
After the completion of the operation, all the patients will be screened for atelectasis, via lung ultrasound, using a well established protocol for the quantification of atelectasis. The results will be statistically analyzed trying to find if any of the forementioned strategies of mechanical ventilation surpasses the other concerning atelectasis appearance.
Furthermore efficiency of lung oxygen absorption, hospital stay, ICU need and mortality will be noted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lung Protective Ventilation | Other | CONVENTIONAL LUNG PROTECTIVE VENTILATION This group is mechanically ventilated with Invasive Mechanical Ventilation with PEEP 8 cm H20 Tidal Volume (VT) 8 ml/kg Ideal Body Weight (IBW) Respiratory Rate (RR) --> PaCO2 = 35-45 mmHg Inspired Oxygen Fraction (FiO2) 0.4 - 0.5 --> Pulse Saturation Oxygen (SpO2) > 93% Recruitment Maneuver (as described) every hour |
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| Minimum Driving Pressure | Active Comparator | This group is mechanically ventilated with Invasive Mechanical Ventilation with PEEP; Initially 8 cm H20, titrated at level with Minimum Driving Pressure after first recruitment - titration maneuver followed by new recruitment maneuver VT 8 ml/kg IBW RR --> PaCO2 = 35-45 mmHg FiO2 0.4 - 0.5 --> SpO2 > 93% Recruitment Maneuver (as described) every hour |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEEP titration for Minimum Driving Pressure | Procedure | This group is mechanically ventilated with Invasive Mechanical Ventilation with Volume Control Ventilation mode with PEEP Initially 8 cm H2O. Afterwards, the lungs are recruited with the aforementioned maneuver. During subsequent derecruitment, PEEP is decreased by 2 cm H20 and compliance is noted in each stage. The goal is to find PEEP with maximum compliance (Cmax). A new recruitment maneuver follows and during derecruitment PEEP is set at the optimum value that was previously defined. VT 8 ml/kg IBW RR --> PaCO2 = 35-45 mmHg FiO2 0.4 - 0.5 --> SpO2 > 93% Recruitment Maneuver (as described) every hour |
| Measure | Description | Time Frame |
|---|---|---|
| Lung Ultrasound Score (LUS) | 12 Position Lung Ultrasound will be performed in Post Anesthesia Care Unit (PACU) within 20 minutes postoperatively. In each position the potential scores will be 0,1,2 and 3. 0 --> 0-2 B-lines
| Within 20 minutes in PACU. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Postoperative Respiratory Failure | Postoperative Respiratory Failure based on Arterial Blood Gases in PACU (type I and/or II) Type I --> Arterial Oxygen Partial Pressure / Arterial Oxygen Saturation (P/F) ratio <300 Type II --> PaCO2 > 45mmHg | Within 30 minutes in PACU |
| Rate of NIMV need |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diamanto Aretha, A. Professor | University of Patras | Study Chair |
| Nektaria Xirouchaki, Consultant | University of Crete | Study Director |
| Eumorfia Kondili, Professor | University of Crete | Study Director |
| Antonios Kostouros, Resident | University of Patras | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Patras | Pátrai | 26504 | Greece |
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| Lung Protective Ventilation | Procedure | This group is mechanically ventilated with Invasive Mechanical Ventilation with Volume Control Ventilation mode with PEEP 8 cm H2O. VT 8 ml/kg IBW RR --> PaCO2 = 35-45 mmHg FiO2 0.4 - 0.5 --> SpO2 > 93% Recruitment Maneuvers (as described) every hour |
|
Potential need for NIMV in PACU due to Respiratory Failure. CPAP / BIPAP / High-Flow Nasal Canula |
| Period of stay in Post Anesthesia Care Unit (PACU). From time of postoperative transfer to PACU until time of discharge from PACU and return to general clinic, an average of 1 hour. |
| Hospital Stay | Total hospital stay days from day of operation until hospital discharge. | From day of operation until the end of patient stay inside hospital, because of return to home or due to death. |
| ICU need. | Potential Need for ICU admission. | From day of operation until the end of patient stay inside hospital, because of return to home or due to death. |
| ICU stay | In case of ICU need, total days of ICU stay. | From day of operation until the end of patient stay inside hospital, because of return to home or due to death. |
| 28 Day mortality | Incidence of death in 28 days in each group. | From day of operation until up to 28 days. |
| Mechanical Power (MP) | o To calculate MP, the following must be recorded: RR, Peak Airway Pressure (Ppeak), Plateau Pressure (Pplat), and PEEP. The simplified equation will be used; MP = 0.098 × RR × [Ppeak - (Plat-PEEP)/2] | From the moment of beginning of operation until the moment of the end of operation and mechanical ventilation |
| Volume-normalized Mechanical Power (MPcrs) | MPcrs = MP/Respiratory System Compliance (Crs) | From the moment of beginning of operation until the moment of the end of operation and mechanical ventilation |
| Elastic Power (EP) | To calculate EP, the following must be recorded: RR, VT, Pplat, and PEEP. The following equation will be used: EP = 0.098 × RR × VT × [(Plat+PEEP)/2] | From the moment of beginning of operation until the moment of the end of operation and mechanical ventilation |
| Volume-normalized Elastic Power (EPcrs) | EPcrs = EP/Crs | From the moment of beginning of operation until the moment of the end of operation and mechanical ventilation |
| ID | Term |
|---|---|
| D001261 | Pulmonary Atelectasis |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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