Lung Ultrasound Assessment of Postoperative Atelectasis After Mechanical Ventilation With Minimum Driving Pressure
- Conditions
- Postoperative AtelectasisLung Ultrasonography ScoreLung UltrasoundPostoperative Pulmonary AtelectasisPostoperative Pulmonary Complications (PPCs)
- Registration Number
- NCT07186920
- Lead Sponsor
- University General Hospital of Patras
- Brief Summary
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:
* Is MV with lower ΔP better than conventional PMV in keeping lungs more open perioperatively and immediately postoperatively?
* Does MV with lower ΔP decrease hospital stay, Intensive Care Unit (ICU) need and mortality?
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 70
- >17 years old
- Surgery with general anesthesia & invasive mechanical ventilation
- ASA score I-III
- <18 years old
- Preoperative ARISCAT score estimation <26
- Women during pregnancy or just given birth
- Other type of anesthesia (Not general)
- Contraindication of administration of neuromuscular blockade agents.
- Contraindication of cease of spontaneous ventilation.
- Mechanical ventilation without endotracheal intubation.
- Severe heart failure / History of ischemic heart disease.
- Moderate or severe chronic obstructive lung disease or interstitial lung disease.
- History of operation in heart, lung or diaphragm.
- Presence of new active pathology in respiratory system at the beginning of surgery (infection / trauma / anatomic disorder).
- Severe intraoperative respiratory complication (laryngospasm / bronchospasm / anaphylaxis).
- Immediate postoperative need for continuation of IMV.
- Patient denial of participation in the trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Lung Ultrasound Score (LUS) Within 20 minutes in PACU. 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
1. --\> \>2 B-lines or presence of small sublpleural consolidations with normal pleural line.
2. --\> Multiple coalescent B-lines or multiple small sublpleural consolidations with thickened or irregular pleural line.
3. --\> Total air loss or subpleural consolidation with diameter bigger than 1x2cm. The total sum of ultrasound scores of each position is marked as LUS.
- Secondary Outcome Measures
Name Time Method Rate of NIMV need 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. Potential need for NIMV in PACU due to Respiratory Failure.
CPAP / BIPAP / High-Flow Nasal CanulaHospital Stay From day of operation until the end of patient stay inside hospital, because of return to home or due to death. Total hospital stay days from day of operation until hospital discharge.
ICU need. From day of operation until the end of patient stay inside hospital, because of return to home or due to death. Potential Need for ICU admission.
ICU stay From day of operation until the end of patient stay inside hospital, because of return to home or due to death. In case of ICU need, total days of ICU stay.
28 Day mortality From day of operation until up to 28 days. Incidence of death in 28 days in each group.
Mechanical Power (MP) From the moment of beginning of operation until the moment of the end of operation and mechanical ventilation 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 × \[Ppeak - (Plat-PEEP)/2\]
Volume-normalized Mechanical Power (MPcrs) From the moment of beginning of operation until the moment of the end of operation and mechanical ventilation MPcrs = MP/Respiratory System Compliance (Crs)
Elastic Power (EP) From the moment of beginning of operation until the moment of the end of operation and mechanical ventilation To calculate EP, the following must be recorded: RR, VT, Pplat, and PEEP. The following equation will be used:
EP = 0.098 × RR × VT × \[(Plat+PEEP)/2\]Volume-normalized Elastic Power (EPcrs) From the moment of beginning of operation until the moment of the end of operation and mechanical ventilation EPcrs = EP/Crs
Rate of Postoperative Respiratory Failure Within 30 minutes in PACU 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