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

NCT04973917 | Completed

• 1 other identifier: 13120001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ventilation Therapy; Complications

Keywords

postoperative care; closed-loop modes; safety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• the physician's workload

  24 hours

Study Arms (2)

conventional ventilation mode

EXPERIMENTAL

respiratory support after cardiac surgery. Vt \< 6 ml/kg PBW, driving pressure \< 13 cmH2O

Procedure: respiratory support

intelectual mode - Intelivent ASV

EXPERIMENTAL

closed loop mode of mechanical ventilation Vt \< 6 ml/kg PBW, driving pressure \< 13 cmH2O

Procedure: respiratory support

Interventions

respiratory support PROCEDURE

respirators for invasive mechanical ventilation

conventional ventilation mode; intelectual mode - Intelivent ASV

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Petrovsky National Research Centre of Surgery: lead

Study Sites (1)

Russian research center of surgery named after academician B. V. Petrovsky

Moscow, Г. Москва, 107140, Russia

Location

Study Officials

• Alexandr Eremenko, Professor

  Russian research center of surgery named after B. V. Petrovsky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 22, 2021
• Study Start: December 20, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)