Ventilation Therapy; ComplicationsNCT04973917
A Comparison of Intellivent-ASV Mode With Conventional Modes in Patients With BMI >35
A study testing respiratory support in people with Ventilation Therapy; Complications, run by Petrovsky National Research Centre of Surgery at 1 site in Russia.
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 Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Ventilation Therapy; Complications
- What is being tested?
- respiratory support
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteRussia
- Study dates
- 20 Dec 2021to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- • 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,
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site
Russian research center of surgery named after academician B. V. Petrovsky
Moscow, Г. Москва, 107140
About this study
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
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
Read the 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.
- Conditions
- Ventilation Therapy; Complications
- Being tested
- respiratory support
- Keywords
- postoperative care, closed-loop modes, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
respiratory supportProcedure or surgery
respirators for invasive mechanical ventilation
| Study group | Role | What they receive |
|---|---|---|
| conventional ventilation mode | Experimental | respiratory support after cardiac surgery. Vt < 6 ml/kg PBW, driving pressure < 13 cmH2O Receives: Procedure: respiratory support |
| intelectual mode - Intelivent ASV | Experimental | closed loop mode of mechanical ventilation Vt < 6 ml/kg PBW, driving pressure < 13 cmH2O Receives: Procedure: respiratory support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During the first 8 hours, since admission on the ICU with the start of the respiratory support
Secondary outcomes (1)
the physician's workload
accounting number of manual ventilator settings changes made before extubation of trachea
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start20 Dec 2021
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilation Therapy; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Petrovsky National Research Centre of Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandr Eremenko, Professor, Principal investigator, Russian research center of surgery named after B. V. Petrovsky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973917
- Sponsor's protocol ID
- 13120001
- Status last verified
- Apr 2023
- First submitted
- 24 Jun 2021
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04973917
- Acronym / sponsor ID
- 13120001
- Conditions
- Ventilation Therapy; Complications
- Keywords
- postoperative care, closed-loop modes, safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Petrovsky National Research Centre of SurgeryUniversity, hospital or other
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional ventilation mode | Experimental | Procedure: respiratory supportrespiratory support after cardiac surgery. Vt < 6 ml/kg PBW, driving pressure < 13 cmH2O |
| intelectual mode - Intelivent ASV | Experimental | Procedure: respiratory supportclosed loop mode of mechanical ventilation Vt < 6 ml/kg PBW, driving pressure < 13 cmH2O |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Age from 30 years to 70 years inclusive
Key exclusion criteria (11 listed)
- • 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.
- chest tube drainage greater than 3 ml/kg/h,
- reoperation,
- myocardial infarction,
- need for high-dose inotropes or vasopressors or intraaortic balloon pump,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| respiratory supportrespirators for invasive mechanical ventilation | Procedure or surgery | conventional ventilation mode, intelectual mode - Intelivent ASV |
Primary outcome
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
1 secondary outcome
the physician's workload
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandr Eremenko, Professor principal investigator
Russian research center of surgery named after B. V. Petrovsky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing respiratory support in people with Ventilation Therapy; Complications, run by Petrovsky National Research Centre of Surgery at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.