Pressure Support Ventilation During Laparoscopic and Abdominal Robotic Surgery.

NCT04815733 | Completed DMC

• 1 other identifier: MoscowCSC
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator-Induced Lung Injury

Keywords

pressure support ventilation; anaesthesia; lung injury; laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

• Concentrations of biomarkers of lung injury

  Measure concentration of Interleukin-6 (IL-6), Interleukin-8 (IL-8), tumor necrosis factor receptor I / II (sTNF rI / II)) in blood serum

  1-3 hours after surgery

Secondary Outcomes (2)

• Maximum intraoperative lactate level in the early postoperative period

  1 hour after surgery

• The maximum level of vasopressor support during surgery

  From time of skin incision to time of skin closure assessed up to 24 hours

Other Outcomes (19)

• Duration of anaesthesia.

  Period of time from induction to volatile anesthetic supply stop assessed up to 24 hours

• Procedure time

  Period of time from intubation to extubation assessed up to 24 hours

• 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

Study Arms (2)

Mandatory ventilation

ACTIVE COMPARATOR

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

Procedure: Mandatory ventilation

Pressure support ventilation

EXPERIMENTAL

partial neuromuscular block and pressure support ventilation (PSVpro).

Procedure: pressure support ventilation

Interventions

Mandatory ventilation PROCEDURE

Use PCV-VG

Mandatory ventilation

pressure support ventilation PROCEDURE

Use PSVpro

Pressure support ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Moscow Clinical Scientific Center: lead

Study Sites (1)

Moscow Clinical Scientific Center

Moscow, Russia

Location

MeSH Terms

Conditions

Ventilator-Induced Lung Injury; Lung Injury

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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.

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: March 25, 2021
• Study Start: June 1, 2017
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)