Ventilator-Induced Lung Injury
Conditions
Keywords
pressure support ventilation, anaesthesia, lung injury, laparoscopic surgery
Brief summary
This study is a single-center, blind, prospective, randomized, controlled trial of pressure support ventilation (PSVpro) versus pressure control ventilation - volume guaranteed (PCV - VG) during laparoscopic and robotic abdominal surgery.
Detailed description
The objective of the study to evaluate the possibility and feasibility of using PSVpro during anesthesia during long-term laparoscopic and robot-assisted abdominal operations at different levels of neuromuscular block. Intervention: We plan to include 100 patients who will undergo elective long (more 2 hours) laparoscopic or abdominal robotic surgery. All patients will be randomly assigned in two groups in ratio 1:1. 1 group- deep neuromuscular block and mandatory ventilation; 2 group- partial neuromuscular block and pressure support ventilation. Expected Results. PSV may reduce the systemic inflammatory response compared to the mandatory ventilation during laparoscopic and abdominal robotic surgery.
Interventions
PROCEDUREMandatory ventilation
Use PCV-VG
PROCEDUREpressure support ventilation
Use PSVpro
Sponsors
Moscow Clinical Scientific Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Intervention model description
t is planned to recruit patients in two groups: group 1-patients who will undergo General anesthesia with deep neuromuscular block and PCV-VG; group 2-patients with partial neuromuscular block and PSVpro. Randomization of patients into two 1:1 groups will be performed by random number generation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Written consent. * Men and women aged 18 years or more. * The physical status from ASA classification I, II or III. * BMI \<= 34.9 kg / m2. * Low risk of respiratory complications. * Laparoscopic surgery in the pelvis.
Exclusion criteria
* The physical status from ASA IV or V. * BMI\> = 35 kg / m2. * Neuromuscular disease. * Allergy to Anesthetic Agents. * Operations on two cavities. * Operations on the chest cavity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentrations of biomarkers of lung injury | 1-3 hours after surgery | Measure concentration of Interleukin-6 (IL-6), Interleukin-8 (IL-8), tumor necrosis factor receptor I / II (sTNF rI / II)) in blood serum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The maximum level of vasopressor support during surgery | From time of skin incision to time of skin closure assessed up to 24 hours | Norepinephrine consumption (mcg/kg/h) |
| Maximum intraoperative lactate level in the early postoperative period | 1 hour after surgery | Maximum intraoperative lactate level |
Other
| Measure | Time frame | Description |
|---|---|---|
| Length of stay (LOS) in the intensive care unit (ICU). | Period of time from ICU arrival to discharge from ICU assessed up to 1 year | Length of stay (LOS) in the intensive care unit (ICU). |
| Time to reach an Aldrete score > 9 points after anaesthesia | Period of time from volatile anesthetic suplly stop to time when patient has more than 9 points according Aldrete score assessed up to 24 hours | Time to reach an Aldrete score \> 9 points after anaesthesia |
| Intraoperative consumption of muscle relaxant | Since skin incision to skin closure assessed up to 24 hours | mg/kg of muscle relaxant |
| Intraoperative consumption of reversal agents. | Since skin incision to skin closure assessed up to 24 hours | mg/kg of reversal agents. |
| Supplemental oxygen in the early postoperative period | Since extubation up to 24 hours after extubation | Duration of oxygen supply |
| Quality of recovery score-40 | 24 hours after surgery | The QoR-40 incorporates five dimensions of health: patient support, comfort, emotions, physical independence, and pain; each item is graded on a five-point Likert scale. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). |
| Changes of spirometry parameter FVC after surgery | 1 hour and 24 hours after surgery | FVC before surgery (L) - FVC after surgery (L) |
| Length of stay (LOS) in hospital | 28 days | Length of stay (LOS) in hospital |
| Changes of spirometry parameter FEV1/FVC after surgery | 1 hour and 24 hours after surgery | FEV1/FVC before surgery (percentage %) - FEV1/FVC after surgery (percentage %) |
| Changes of spirometry parameter PEF after surgery | 1 hour and 24 hours after surgery | PEF before surgery (L/s) - PEF after surgery (L/s) |
| Changes of spirometry parameter VC after surgery | 1 hour and 24 hours after surgery | VC before surgery (L) - VC after surgery (L) |
| Changes of spirometry parameter FEV1/VC after surgery | 1 hour and 24 hours after surgery | FEV1/VC before surgery (percentage %) - FEV1/VC after surgery (percentage %) |
| Volume of atelectasis of lungs after surgery | 24 hours after surgery | Volume of the lungs measure according to CT lung The volume of atelectasis is the difference in volumes of lungs before and after surgery |
| The level of pain assess after surgery by Numeric Rating Scale (NRS) | 1 hour after surgery | No pain - 0, worst pain - 10 |
| Changes of spirometry parameter FEV1 after surgery | 1 hour and 24 hours after surgery | FEV1 before surgery (L)- FEV1 after surgery (L) |
| Duration of anaesthesia. | Period of time from induction to volatile anesthetic supply stop assessed up to 24 hours | Duration of anaesthesia. |
| Procedure time | Period of time from intubation to extubation assessed up to 24 hours | Length of ventilation |
Countries
Russia
Outcome results
None listed