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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04973917

Enrollment

Registered

2021-07-22

Start date

2021-12-20

Completion date

2023-02-01

Last updated

2023-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilation Therapy; Complications

Keywords

postoperative care, closed-loop modes, safety

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.

Interventions

PROCEDURErespiratory support

respirators for invasive mechanical ventilation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

30 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Percentage of patients with tidal volume in optimal, suboptimal, unoptimal zone	During the first 8 hours, since admission on the ICU with the start of the respiratory support	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

Secondary

Measure	Time frame	Description
the physician's workload	24 hours	accounting number of manual ventilator settings changes made before extubation of trachea

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026