A Comparison of Intellivent-ASV Mode With Conventional Modes in Patients With BMI >35

A Prospective Comparison of the Efficacy and Safety of Intellectual Mode of Ventilation (Intellivent-ASV) With Conventional Modes in Cardiac Surgery Patients With Body Mass Index >35

compare effects of intellectual mode (in our case it will be Intellivent - ASV -) with conventional ventilation modes after uncomplicated cardiac surgery in patients with body mass index >35

Study Overview

• Status: Completed
• Conditions: Ventilation Therapy; Complications
• Intervention / Treatment: Procedure: respiratory support

Detailed Description

The study includes the comparison of two methods of invasive respiratory support ventilation( conventional ventilation modes and automatic IntelliventASV mode (a fully automated, or closed-loop, ventilation mode that consists of pressure-controlled ventilation or pressure support ventilation depending on a patient's respiratory activity. In fully automated ventilation mode, tidal volume, pressure levels (including PEEP), minute ventilation, and the oxygen fraction in inspired air are controlled solely by the ventilator) after uncomplicated cardiac surgery). It assumes 30 randomized patients:15 patients in two study groups male and female aged 30 to 70 years of age inclusive, with BMI > 35 kg/m2. The study will be randomized, single-center, prospective.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roman Komnov; Phone Number: +79263539380; Email: drrkom@mail.ru

Study Locations

• Russian Federation
  • Г. Москва
    • Moscow, Г. Москва, Russian Federation, 107140
      • Russian research center of surgery named after academician B. V. Petrovsky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • Age from 30 years to 70 years inclusive

  • elective cardiac surgery which included bypass, valve and ascending aortic surgery,
  • a body mass index of > 35 kg/m2,
  • postoperative treatment with mechanical ventilation,
  • informed consent

Exclusion Criteria:

• • GFI <30 ml/min before surgery, serum aspartate and alanine transaminase concentration greater than 80 U/l before surgery, left ventricular ejection fraction less than 30% before surgery.

Postoperative exclusion criteria:

• chest tube drainage greater than 3 ml/kg/h,
• reoperation,
• myocardial infarction,
• need for high-dose inotropes or vasopressors or intraaortic balloon pump,
• presence of a bronchopleural fistula and refractory hypoxemia with an arterial oxygen tension to fractional inspired oxygen concentration ratio less than 150 mmHg,
• perioperative anaphylactic reaction,
• seizures,
• stroke,
• agitation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: conventional ventilation mode; respiratory support after cardiac surgery. Vt < 6 ml/kg PBW, driving pressure < 13 cmH2O	Procedure: respiratory support; respirators for invasive mechanical ventilation
Experimental: intelectual mode - Intelivent ASV; closed loop mode of mechanical ventilation Vt < 6 ml/kg PBW, driving pressure < 13 cmH2O	Procedure: respiratory support; respirators for invasive mechanical ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with tidal volume in optimal, suboptimal, unoptimal zone	Number of Participants during mechanical ventilation with Tidal volume in optimal zone < 6 ml/kg/Predicted Body Weight ; Tidal volume in suboptimal zone 6-8 ml/kg/Predicted Body Weight Tidal volume in unoptimal zone >8 ml/kg/Predicted Body Weight	During the first 8 hours, since admission on the ICU with the start of the respiratory support

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the physician's workload	accounting number of manual ventilator settings changes made before extubation of trachea	24 hours

Collaborators and Investigators

• Sponsor: Petrovsky National Research Centre of Surgery
• Investigators: Principal Investigator: Alexandr Eremenko, Professor, Russian research center of surgery named after B. V. Petrovsky

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2021
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: June 24, 2021
• First Submitted That Met QC Criteria: July 20, 2021
• First Posted (Actual): July 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: safety; postoperative care; closed-loop modes
• Other Study ID Numbers: 13120001

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