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NCT Number: NCT04973917

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

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

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Moscow, Г. Москва, 107140, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

respiratory support

Procedure

respirators for invasive mechanical ventilation

Primary outcomes

  1. Percentage of patients with tidal volume in optimal, suboptimal, unoptimal zone

    Time frame: 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 outcomes

  1. the physician's workload

    Time frame: 24 hours

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

Sponsors and collaborators

Lead sponsor

Petrovsky National Research Centre of Surgery

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 22, 2021
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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