Pressure Support Ventilation During Laparoscopic and Abdominal Robotic Surgery.

April 25, 2023 updated by: Valerii Subbotin, Moscow Clinical Scientific Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mandatory ventilation
deep neuromuscular block and mandatory ventilation (PCV-VG);
Procedure: Mandatory ventilation
Use PCV-VG
Experimental: Pressure support ventilation
partial neuromuscular block and pressure support ventilation (PSVpro).
Procedure: pressure support ventilation
Use PSVpro

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentrations of biomarkers of lung injury
Time Frame: 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
1-3 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum intraoperative lactate level in the early postoperative period
Time Frame: 1 hour after surgery
Maximum intraoperative lactate level
1 hour after surgery
The maximum level of vasopressor support during surgery
Time Frame: From time of skin incision to time of skin closure assessed up to 24 hours
Norepinephrine consumption (mcg/kg/h)
From time of skin incision to time of skin closure assessed up to 24 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of anaesthesia.
Time Frame: Period of time from induction to volatile anesthetic supply stop assessed up to 24 hours
Duration of anaesthesia.
Period of time from induction to volatile anesthetic supply stop assessed up to 24 hours
Procedure time
Time Frame: Period of time from intubation to extubation assessed up to 24 hours
Length of ventilation
Period of time from intubation to extubation assessed up to 24 hours
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
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
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
Time to reach an Aldrete score > 9 points after anaesthesia
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
Intraoperative consumption of muscle relaxant
Time Frame: Since skin incision to skin closure assessed up to 24 hours
mg/kg of muscle relaxant
Since skin incision to skin closure assessed up to 24 hours
Intraoperative consumption of reversal agents.
Time Frame: Since skin incision to skin closure assessed up to 24 hours
mg/kg of reversal agents.
Since skin incision to skin closure assessed up to 24 hours
Supplemental oxygen in the early postoperative period
Time Frame: Since extubation up to 24 hours after extubation
Duration of oxygen supply
Since extubation up to 24 hours after extubation
Quality of recovery score-40
Time Frame: 24 hours after surgery

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).
24 hours after surgery
Changes of spirometry parameter FVC after surgery
Time Frame: 1 hour and 24 hours after surgery
FVC before surgery (L) - FVC after surgery (L)
1 hour and 24 hours after surgery
Changes of spirometry parameter FEV1 after surgery
Time Frame: 1 hour and 24 hours after surgery
FEV1 before surgery (L)- FEV1 after surgery (L)
1 hour and 24 hours after surgery
Changes of spirometry parameter FEV1/FVC after surgery
Time Frame: 1 hour and 24 hours after surgery
FEV1/FVC before surgery (percentage %) - FEV1/FVC after surgery (percentage %)
1 hour and 24 hours after surgery
Changes of spirometry parameter PEF after surgery
Time Frame: 1 hour and 24 hours after surgery
PEF before surgery (L/s) - PEF after surgery (L/s)
1 hour and 24 hours after surgery
Changes of spirometry parameter VC after surgery
Time Frame: 1 hour and 24 hours after surgery
VC before surgery (L) - VC after surgery (L)
1 hour and 24 hours after surgery
Changes of spirometry parameter FEV1/VC after surgery
Time Frame: 1 hour and 24 hours after surgery
FEV1/VC before surgery (percentage %) - FEV1/VC after surgery (percentage %)
1 hour and 24 hours after surgery
Volume of atelectasis of lungs after surgery
Time Frame: 24 hours after surgery
Volume of the lungs measure according to CT lung The volume of atelectasis is the difference in volumes of lungs before and after surgery
24 hours after surgery
The level of pain assess after surgery by Numeric Rating Scale (NRS)
Time Frame: 1 hour after surgery
No pain - 0, worst pain - 10
1 hour after surgery
The level of pain assess after surgery by Numeric Rating Scale (NRS)
Time Frame: 3 hours after surgery
No pain - 0, worst pain - 10
3 hours after surgery
The level of pain assess after surgery by Numeric Rating Scale (NRS)
Time Frame: 24 hours after surgery
No pain - 0, worst pain - 10
24 hours after surgery
Length of stay (LOS) in hospital
Time Frame: 28 days
Length of stay (LOS) in hospital
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Moscow Clinical Scientific Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

March 31, 2023

Study Completion (Actual)

March 31, 2023

Study Registration Dates

First Submitted

October 28, 2020

First Submitted That Met QC Criteria

March 22, 2021

First Posted (Actual)

March 25, 2021

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 25, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MoscowCSC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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