Clinical trial NCT04815733: Pressure Support Ventilation During Laparoscopic and Abdominal Robotic Surgery.
Official title: Pressure Support Ventilation During Laparoscopic and Abdominal Robotic Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator-Induced Lung Injury
Keywords: pressure support ventilation
anaesthesia
lung injury
laparoscopic surgery
Lead sponsor: Moscow Clinical Scientific Center
Sponsor class: OTHER
First posted: 2021-03-25
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Concentrations of biomarkers of lung injury
timeFrame: 1-3 hours after surgery
Secondary outcomes:
measure: Maximum intraoperative lactate level in the early postoperative period
timeFrame: 1 hour after surgery
measure: The maximum level of vasopressor support during surgery
timeFrame: From time of skin incision to time of skin closure assessed up to 24 hours
Other outcomes:
measure: Duration of anaesthesia.
timeFrame: Period of time from induction to volatile anesthetic supply stop assessed up to 24 hours
measure: Procedure time
timeFrame: Period of time from intubation to extubation assessed up to 24 hours
measure: Length of stay (LOS) in the intensive care unit (ICU).
timeFrame: Period of time from ICU arrival to discharge from ICU assessed up to 1 year
measure: Time to reach an Aldrete score > 9 points after anaesthesia
timeFrame: 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
measure: Intraoperative consumption of muscle relaxant
timeFrame: Since skin incision to skin closure assessed up to 24 hours
measure: Intraoperative consumption of reversal agents.
timeFrame: Since skin incision to skin closure assessed up to 24 hours
measure: Supplemental oxygen in the early postoperative period
timeFrame: Since extubation up to 24 hours after extubation
measure: Quality of recovery score-40
timeFrame: 24 hours after surgery
measure: Changes of spirometry parameter FVC after surgery
timeFrame: 1 hour and 24 hours after surgery
measure: Changes of spirometry parameter FEV1 after surgery
timeFrame: 1 hour and 24 hours after surgery
measure: Changes of spirometry parameter FEV1/FVC after surgery
timeFrame: 1 hour and 24 hours after surgery
measure: Changes of spirometry parameter PEF after surgery
timeFrame: 1 hour and 24 hours after surgery
measure: Changes of spirometry parameter VC after surgery
timeFrame: 1 hour and 24 hours after surgery
measure: Changes of spirometry parameter FEV1/VC after surgery
timeFrame: 1 hour and 24 hours after surgery
measure: Volume of atelectasis of lungs after surgery
timeFrame: 24 hours after surgery
measure: The level of pain assess after surgery by Numeric Rating Scale (NRS)
timeFrame: 1 hour after surgery
measure: The level of pain assess after surgery by Numeric Rating Scale (NRS)
timeFrame: 3 hours after surgery
measure: The level of pain assess after surgery by Numeric Rating Scale (NRS)
timeFrame: 24 hours after surgery
measure: Length of stay (LOS) in hospital
timeFrame: 28 days
Locations:
city: Moscow
country: Russian Federation
facility: Moscow Clinical Scientific Center
Study officials:
References: