Pressure Support Ventilation During Laparoscopic and Abdominal Robotic Surgery.

Not Applicable

Completed

• Conditions: Ventilator-Induced Lung Injury
• Interventions: Procedure: Mandatory ventilation; Procedure: pressure support ventilation

• Registration Number: NCT04815733
• Lead Sponsor: Moscow Clinical Scientific Center

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.

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2020-10-28
• Study First Submitted QC: 2021-03-22
• Study First Posted: 2021-03-25
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-25
• Last Update Posted: 2023-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mandatory ventilation	Mandatory ventilation	deep neuromuscular block and mandatory ventilation (PCV-VG);
Pressure support ventilation	pressure support ventilation	partial neuromuscular block and pressure support ventilation (PSVpro).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Moscow Clinical Scientific Center; 🇷🇺 Moscow, Russian Federation