Clinical trial NCT04973917: A Comparison of Intellivent-ASV Mode With Conventional Modes in Patients With BMI >35
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilation Therapy; Complications
Keywords: postoperative care
closed-loop modes
safety
Lead sponsor: Petrovsky National Research Centre of Surgery
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 32
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Percentage of patients with tidal volume in optimal, suboptimal, unoptimal zone
timeFrame: During the first 8 hours, since admission on the ICU with the start of the respiratory support
Secondary outcomes:
measure: the physician's workload
timeFrame: 24 hours
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Russian research center of surgery named after academician B. V. Petrovsky
state: Г. Москва
Study officials:
affiliation: Russian research center of surgery named after B. V. Petrovsky
name: Alexandr Eremenko, Professor
role: PRINCIPAL_INVESTIGATOR
References: