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Pressure Support Ventilation During Laparoscopic and Abdominal Robotic Surgery.

Primary Purpose

Ventilator-Induced Lung Injury

Status

Completed

Phase

Not Applicable

Locations

Russian Federation

Study Type

Interventional

Intervention

Mandatory ventilation

pressure support ventilation

About this trial

This is an interventional prevention trial for Ventilator-Induced Lung Injury focused on measuring pressure support ventilation, anaesthesia, lung injury, laparoscopic surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

Moscow Clinical Scientific Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Mandatory ventilation

Pressure support ventilation

Arm Description

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

partial neuromuscular block and pressure support ventilation (PSVpro).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Maximum intraoperative lactate level in the early postoperative period

Maximum intraoperative lactate level

The maximum level of vasopressor support during surgery

Norepinephrine consumption (mcg/kg/h)

Full Information

NCT ID

NCT04815733

First Posted

October 28, 2020

Last Updated

April 25, 2023

Sponsor

Moscow Clinical Scientific Center

1. Study Identification

Unique Protocol Identification Number

NCT04815733

Brief Title

Pressure Support Ventilation During Laparoscopic and Abdominal Robotic Surgery.

Official Title

Pressure Support Ventilation During Laparoscopic and Abdominal Robotic Surgery.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

June 1, 2017 (Actual)

Primary Completion Date

March 31, 2023 (Actual)

Study Completion Date

March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Moscow Clinical Scientific Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ventilator-Induced Lung Injury

Keywords

pressure support ventilation, anaesthesia, lung injury, laparoscopic surgery

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

106 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mandatory ventilation

Arm Type

Active Comparator

Arm Description

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

Arm Title

Pressure support ventilation

Arm Type

Experimental

Arm Description

partial neuromuscular block and pressure support ventilation (PSVpro).

Intervention Type

Procedure

Intervention Name(s)

Mandatory ventilation

Intervention Description

Use PCV-VG

Intervention Type

Procedure

Intervention Name(s)

pressure support ventilation

Intervention Description

Use PSVpro

Primary Outcome Measure Information:

Title

Concentrations of biomarkers of lung injury

Description

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

Time Frame

1-3 hours after surgery

Secondary Outcome Measure Information:

Title

Maximum intraoperative lactate level in the early postoperative period

Description

Maximum intraoperative lactate level

Time Frame

1 hour after surgery

Title

The maximum level of vasopressor support during surgery

Description

Norepinephrine consumption (mcg/kg/h)

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Duration of anaesthesia.

Description

Duration of anaesthesia.

Time Frame

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

Title

Procedure time

Description

Length of ventilation

Time Frame

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

Title

Length of stay (LOS) in the intensive care unit (ICU).

Description

Length of stay (LOS) in the intensive care unit (ICU).

Time Frame

Period of time from ICU arrival to discharge from ICU assessed up to 1 year

Title

Time to reach an Aldrete score > 9 points after anaesthesia

Description

Time to reach an Aldrete score > 9 points after anaesthesia

Time Frame

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

Title

Intraoperative consumption of muscle relaxant

Description

mg/kg of muscle relaxant

Time Frame

Since skin incision to skin closure assessed up to 24 hours

Title

Intraoperative consumption of reversal agents.

Description

mg/kg of reversal agents.

Time Frame

Since skin incision to skin closure assessed up to 24 hours

Title

Supplemental oxygen in the early postoperative period

Description

Duration of oxygen supply

Time Frame

Since extubation up to 24 hours after extubation

Title

Quality of recovery score-40

Description

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).

Time Frame

24 hours after surgery

Title

Changes of spirometry parameter FVC after surgery

Description

FVC before surgery (L) - FVC after surgery (L)

Time Frame