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

NCT ID: NCT04973917

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-20
• Study Completion Date: 2023-02-01

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

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.

Conditions

Ventilation Therapy; Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

conventional ventilation mode

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

Group Type: EXPERIMENTAL

respiratory support

Intervention Type: PROCEDURE

respirators for invasive mechanical ventilation

intelectual mode - Intelivent ASV

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

Group Type: EXPERIMENTAL

respiratory support

Intervention Type: PROCEDURE

respirators for invasive mechanical ventilation

Interventions

respiratory support

respirators for invasive mechanical ventilation

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Petrovsky National Research Centre of Surgery

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandr Eremenko, Professor

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Moscow, Г. Москва, Russia

Countries

Russia

Other Identifiers

13120001

Identifier Type: -

Identifier Source: org_study_id