Trial Title:
Evaluating Respiratory Effects of Driving Pressure Guided Mechanical Ventilation Using Electrical Impedance Tomography in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy
NCT ID:
NCT06540794
Condition:
Prostate Cancer
Lung Protective Ventilation
Postoperative Pulmonary Complications
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
driving pressure
electrical impedance tomography
robot assisted laparoscopic prostatectomy
peep titration
recruitment
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Other
Masking:
Double (Participant, Outcomes Assessor)
Summary:
Robot-Assisted Laparoscopic Radical Prostatectomy is a method increasingly used for
prostate cancer due to fewer complications, morbidity, and mortality compared to other
methods. The technique involves inflating the abdomen with carbon dioxide to provide
visualization and working in a steep Trendelenburg position, which puts pressure on the
lungs and can cause them to collapse. The functional residual capacity reduction caused
by general anesthesia, combined with the negative effects of the position, increases the
risk of significant respiratory system complications during and after surgery.
Lung protective ventilation strategies can reduce the incidence of postoperative
pulmonary complications (PPC) by alleviating iatrogenic injury to previously healthy
lungs. Apart from a low tidal volume (VT), applying positive end-expiratory pressure
(PEEP) can minimize the risk of atelectasis and/or overdistension.
There is limited information on how to adjust optimal PEEP under increased
intra-abdominal pressure during laparoscopy. A meta-analysis study on acute respiratory
distress syndrome (ARDS) patients showed that high driving pressure (plateau pressure -
PEEP) is the most associated value with mortality. It was shown that VT, plateau
pressure, and PEEP are not related to patient outcomes or only when they affect driving
pressure. Subsequent retrospective and prospective studies confirmed the importance of
driving pressure in ARDS patients and surgical patients.
For patients under mechanical ventilation, applying a personalized PEEP that provides the
lowest driving pressure, along with maneuvers to open closed alveoli (recruitment),
reduces respiratory system complications during and after surgery. One method to
visualize the effects of these maneuvers and the ideal PEEP application, which provides
the lowest driving pressure for the patient, is electrical impedance tomography (EIT), a
non-invasive, radiation-free bedside imaging technique.
EIT, measured with 16 electrodes placed on an elastic belt around the
patient's 4th to 6th ribs, shows impedance changes in the lungs. This method
successfully visualizes and evaluates dynamic changes in gas distribution within the
lungs and has been validated by computed tomography scans, proving safe for use in both
adults and pediatric patients. EIT divides the lungs into four layers from ventral to
dorsal, showing the percentage distribution of tidal volume in these regions. Examining
the relative impedance changes allows for observing gas volume distribution entering the
lungs and evaluating regional lung characteristics.
Therefore, EIT can contribute to examining the PEEP value that ensures homogeneous gas
distribution in the lungs and preventing ventilator-associated lung injury.
The aim of our study is to evaluate the effect of driving pressure guided mechanical
ventilation on lung gas distribution during robot-assisted laparoscopic radical
prostatectomy through respiratory parameters recorded by EIT during surgery and
perioperative period and to compare perioperative pulmonary complications with
traditional ventilation methods
Detailed description:
General anesthesia increases the risk of respiratory complications and impairs arterial
oxygenation by causing atelectasis in the dorsal regions of the lungs. Postoperative
pulmonary complications (PPC) represent events such as atelectasis, pulmonary edema,
pneumonia, pleuritis, reintubation, and the need for oxygen support after surgery, and
are associated with increased morbidity, mortality, intensive care, and hospital stay
durations, as well as higher healthcare costs. The effective strategy to reduce the
incidence of PPC in patients under general anesthesia is still not clear.
Robot-assisted surgeries are increasingly preferred for prostatectomy, a curative
treatment for prostate cancer, due to advantages such as less blood loss, less scar
tissue formation, and shorter hospital stays compared to other surgical methods. During
robotic surgery, many factors such as laparoscopy, pneumoperitoneum, and extreme
Trendelenburg position can negatively affect lung function. Studies have shown that high
driving pressure values, resulting from the set tidal volume target and PEEP values
during mechanical ventilation, increase postoperative pulmonary complications.
Developing mechanical ventilation strategies based on personalized PEEP values that
provide the lowest driving pressure after recruitment maneuvers to include closed alveoli
in respiration and monitoring the effects of this method on the lungs during the
perioperative period using electrical impedance tomography (EIT) is a highly useful tool.
EIT, a non-invasive, radiation-free bedside monitoring system that detects real-time
regional ventilation changes, can be used to guide individualized protective ventilation
strategies to reduce perioperative respiratory system complications. Examining ROI values
measured by EIT shows the effect of ventilation strategies on the distribution of tidal
volume in the lungs. ROIs calculated by selecting layers, with ROI 1 and ROI 2 reflecting
the ventral parts and ROI 3 and ROI 4 reflecting the dorsal parts, can be used to
demonstrate the effect of the chosen ventilation strategy on lung gas distribution
through intergroup comparison.
The age, gender, height, weight, body mass index, diagnosis, ASA score, preoperative
hemoglobin level, additional systemic diseases, smoking history, prostate-specific
antigen level, Gleason score, and prostate volume of the patients will be recorded. All
patients will be monitored with electrocardiogram (ECG), peripheral oxygen saturation
(SpO2), invasive arterial pressure (systolic arterial pressure, diastolic arterial
pressure, and mean arterial pressure), and electrical impedance tomography. Patients will
be prospectively randomized into two groups; group assignments will be determined using a
closed-envelope technique.
All patients will be preoxygenated with 80% FiO2, followed by induction of anesthesia
with 2 mcg/kg fentanyl, 2 mg/kg propofol, and 0.6 mg/kg rocuronium. After orotracheal
intubation, patients will be placed on mechanical ventilation in volume control-autoflow
mode with 8 ml/kg tidal volume, 2 L/min fresh gas flow, 0.4 inspired fractional oxygen
(FiO2), an inspiratory: expiratory ratio of 1:2, and a respiratory rate to achieve
normocapnia (partial carbon dioxide pressure PaCO2: 35-45 mmHg). Recruitment maneuvers
will be applied to all patients.
During the recruitment maneuver: with an inspiratory: expiratory ratio of 1:1, a
respiratory rate of 12 breaths/min, ventilation with a tidal volume of 8 ml/kg will be
applied for 1 minute at a PEEP level of 5 cmH2O. This will be followed by ventilation
with a tidal volume of 10 ml/kg for 1 minute at 10 cmH2O PEEP, and finally, ventilation
with a tidal volume of 12 ml/kg for 1 minute at 15 cmH2O PEEP.The mechanical ventilation
strategies for the patients will be planned according to their group.
For all patients, systolic arterial pressure, diastolic arterial pressure, mean arterial
pressure, heart rate, and SpO2 values will be recorded before induction, after
intubation, at 5-minute intervals for up to 60 minutes after pneumoperitoneum and
Trendelenburg position, at 60 minutes after Trendelenburg position , at 75 minutes after
Trendelenburg position , at 90 minutes after Trendelenburg position, at 120 minutes after
Trendelenburg position, at 180 minutes after Trendelenburg position, at 240 minutes after
Trendelenburg position, before extubation, 5 minutes after extubation , at 60 minutes
postoperatively , at 24 hours postoperatively , and at 48 hours postoperatively .
Additionally, while the patient is on mechanical ventilation, peak pressure, plateau
pressure, PEEP, mean airway pressure (MPaw), compliance, and end-tidal carbon dioxide
values will also be recorded.
Intermittent arterial blood gas analysis with invasive arterial monitoring is a routine
practice in our daily practice. Arterial blood gas analysis will be performed
preoperatively, immediately after intubation, at 15, 60, and 120 minutes after
pneumoperitoneum and Trendelenburg position, immediately before extubation, and 5 minutes
after extubation, with pH, partial oxygen pressure (pO2), partial carbon dioxide pressure
(pCO2), oxygenation index (pO2/FiO2), bicarbonate, lactate, and hemoglobin values
recorded.
Anesthesia duration, perioperative fluid volume, perioperative blood loss and urine
output, operation duration, pneumoperitoneum duration, mechanical ventilation duration,
and vasoactive agent use duration will be recorded.
In all patients, ROI values measured by electrical impedance tomography, which we use
routinely in our daily practice, will be recorded before intubation, immediately after
intubation, at 15, 60, and 120 minutes after pneumoperitoneum and Trendelenburg position,
immediately before extubation in the supine position, and 5 minutes after extubation.
Postoperative pulmonary complications in patients will be monitored using SpO2, fever,
cough, and sputum history, as well as prolonged intubation if present, and the duration
of oxygen support and the development of additional pathology will be recorded.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- ASA score of I-II-III according to the American Society of Anesthesiologists (ASA)
physical status classification system
- Surgery duration is expected to be longer than 2 hours
Exclusion Criteria:
- Patients who underwent surgery requiring mechanical ventilation for more than 1 hour
within 2 weeks before the operation
- Patients with a body mass index over 35
- Patients with large bullae or pneumothorax, those currently receiving oxygen
support, those with severe respiratory disease
- Patients with severe heart failure classified as NYHA class III-IV by the New York
Heart Association (NYHA), those with a pacemaker or cardiac defibrillator implant
- Patients with progressive neuromuscular disease
- Patients who refused to participate in the study were excluded.
Gender:
Male
Minimum age:
N/A
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
July 16, 2024
Completion date:
October 2024
Lead sponsor:
Agency:
Istanbul University
Agency class:
Other
Source:
Istanbul University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06540794
