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

Petrovsky National Research Centre of Surgery32 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Ventilation Therapy; Complications

Interventions

respiratory supportPROCEDURE

respirators for invasive mechanical ventilation

Eligibility

Sex: ALLMin age: 30 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Moscow, Г. Москва, Russia

Outcomes

Primary Outcomes

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

Time frame: During the first 8 hours, since admission on the ICU with the start of the respiratory support

Secondary Outcomes

the physician's workload

accounting number of manual ventilator settings changes made before extubation of trachea

Time frame: 24 hours

Data from ClinicalTrials.gov

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