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

Petrovsky National Research Centre of Surgery

Status: Completed

Conditions: Ventilation Therapy; Complications

Treatments: Procedure: respiratory support

Study type: Interventional

Funder types: Other

Identifiers

NCT04973917

13120001

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

conventional ventilation mode

Experimental group

Description:

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

Treatment:

Procedure: respiratory support

intelectual mode - Intelivent ASV

Experimental group

Description:

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

Treatment:

Procedure: respiratory support