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

Ventilation Therapy; Complications Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04973917
• Other study ID #: 13120001
• Status: Completed
• Phase: N/A
• Start date: December 20, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: April 2023
• Source: Petrovsky National Research Centre of Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Ventilation Therapy; Complications

Intervention

Procedure:
• respiratory support
respirators for invasive mechanical ventilation

Locations

Country	Name	City	State
Russian Federation	Russian research center of surgery named after academician B. V. Petrovsky	Moscow	?. ??????

Sponsors (1)

Lead Sponsor	Collaborator
Petrovsky National Research Centre of Surgery

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	During the first 8 hours, since admission on the ICU with the start of the respiratory support
Secondary	the physician's workload	accounting number of manual ventilator settings changes made before extubation of trachea	24 hours