Pressure Support Ventilation During Laparoscopic and Abdominal Robotic Surgery.

Moscow Clinical Scientific Center

Status: Completed

Conditions: Ventilator-Induced Lung Injury

Treatments: Procedure: pressure support ventilation; Procedure: Mandatory ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT04815733

MoscowCSC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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106 participants in 2 patient groups

Mandatory ventilation

Active Comparator group

Description:

deep neuromuscular block and mandatory ventilation (PCV-VG);

Treatment:

Procedure: Mandatory ventilation

Pressure support ventilation

Experimental group

Description:

partial neuromuscular block and pressure support ventilation (PSVpro).

Treatment:

Procedure: pressure support ventilation