Pressure Support Ventilation During Laparoscopic and Abdominal Robotic Surgery.

NCT ID: NCT04815733

Last Updated: 2023-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2023-03-31

Brief Summary

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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

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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.

Conditions

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Ventilator-Induced Lung Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Mandatory ventilation

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

Group Type ACTIVE_COMPARATOR

Mandatory ventilation

Intervention Type PROCEDURE

Use PCV-VG

Pressure support ventilation

partial neuromuscular block and pressure support ventilation (PSVpro).

Group Type EXPERIMENTAL

pressure support ventilation

Intervention Type PROCEDURE

Use PSVpro

Interventions

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Mandatory ventilation

Use PCV-VG

Intervention Type PROCEDURE

pressure support ventilation

Use PSVpro

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Moscow Clinical Scientific Center

OTHER

Sponsor Role lead

Responsible Party

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Valerii Subbotin

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Moscow Clinical Scientific Center

Moscow, , Russia

Site Status

Countries

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Russia

Other Identifiers

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MoscowCSC

Identifier Type: -

Identifier Source: org_study_id

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