Mechanical Ventilation ComplicationWEAN-IPINCT02524522
Perioperative Mechanical Ventilation and Postoperative Monitoring of IPI
A study testing INTELLiVENT-ASV mode and SIMV mode in people with Mechanical Ventilation Complication and Postoperative Pulmonary Atelectasis, run by Northern State Medical University at 1 site in Russia.
Trial summary
This study evaluates the influence of alveolar recruitment maneuver, protocolized liberation from respiratory support and monitoring of Integrated Pulmonary Index on the duration of the mechanical ventilation and the number of pulmonary complications in the early postoperative period after cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication, Postoperative Pulmonary Atelectasis
- What is being tested?
- INTELLiVENT-ASV mode and SIMV mode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteRussia
- Study dates
- Aug 2015to Feb 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent.
- Elective OPCAB.
Who cannot join
- Participation in any other study.
- Morbid obesity (BWI > 40).
- The risk of pneumothorax after alveolar recruitment due to pulmonary emphysema.
- Constant atrial fibrillation with pulse rate exceeding 100/min.
- Inability to breathe easily through the nostrils and thus to gain good quality EtCO2 readings while breathing spontaneously, due to chronic rhinitis.
Trial locations and contacts
1 site in 1 country.
Russia1 site
City hospital # 1 / Northern State Medical University,
Arkhangelsk, 163001
About this study
Official title: Perioperative Pulmonary Recruitment and Postoperative Monitoring of Integrated Pulmonary Index in Off-pump Coronary Bypass Grafting
This study evaluates the influence of alveolar recruitment maneuver, protocolized liberation from respiratory support and monitoring of Integrated Pulmonary Index on the duration of the mechanical ventilation and the number of pulmonary complications in the early postoperative period after cardiac surgery.
Read the detailed description
The outcome of elective off-pump coronary artery bypass grafting (OPCAB) can be significantly compromised due to early postoperative pulmonary complications. The risk of pulmonary complications including acute respiratory distress syndrome (ARDS), atelectases, and early ventilator-associated pneumonia remains inappropriate. Therefore, the maneuvers improving pulmonary aeration and the early restoration of spontaneous breathing activity can be of clinical value. Protocol-driven liberation from mechanical ventilation (CMV) can decrease the duration of CMV as well as the number of pulmonary complications. INTELLiVENT-Assisted spontaneous ventilation (INTELLiVENT-ASV) is a new approach, that may be as effective as conventional protocol-driven liberation from CMV.
In parallel, the thorough postoperative monitoring of pulmonary function during both postoperative mechanical ventilation and spontaneous breathing is also of a great value. One of the novel approaches to respiratory monitoring is Integrated Pulmonary Index (IPI). The Integrated Pulmonary Index merges four vital parameters including end-tidal carbon dioxide (EtCO2), respiratory rate, pulse rate, and oxygen saturation (SpO2) measured by capnography and pulse oximetry into a single index value utilizing fuzzy logic model .
- Being tested
- INTELLiVENT-ASV mode, SIMV mode
- Keywords
- Integrated Pulmonary Index, automated protocol-driven weaning, pulmonary recruitment maneuver
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTELLiVENT-ASV modeDevice
Discontinuation with INTELLiVENT-ASV mode: discontinuation from mechanical ventilation in the early postoperative period will be provided by quick-wean option of INTELLiVENT-ASV mode
SIMV modeDevice
Discontinuation with SIMV mode: discontinuation with SIMV mode: discontinuation from mechanical ventilation in the early postoperative period will be provided in SIMV mode using physician driven algorithm
| Study group | Role | What they receive |
|---|---|---|
| INTELLiVENT-ASV mode | Active comparator | Active comparator: Discontinuation of mechanical ventilation in postoperative period will be provided using automatically driven mode - INTELLiVENT-ASV. In the INTELLiVENT-ASV mode target EtCO2 will be 30-35 mm Hg, target SpO2 - 94-98%, quick wean option - activated. Receives: Device: INTELLiVENT-ASV mode |
| SIMV mode | Active comparator | Active comparator: Discontinuation from mechanical ventilation in postoperative period will be provided using physician driven protocol. The synchronized intermittent mandatory ventilation (SIMV) mode settings will be as follows: PEEP 5 cm of water, FiO2 to achieve SpO2 > 94 %. Inspiratory pressure will be adjusted to deliver a tidal volume (VT) of 8 mL/kg predicted body weight; pressure support will be 2 cm of water higher. Respiratory rate (RR) will be adjusted to provide EtCO2 of 30-35 mm Hg. Respiratory rate and inspiratory pressure will be decreased gradually every 30 minutes. After decrease of inspiratory pressure to 6 cm of water (8 cm of water in case of BMI > 30 kg/m2) and respiratory rate to 6/min, the spontaneous breathing trial (SBT) will be started. Receives: Device: SIMV mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of postoperative mechanical ventilation
Participants will be followed for the duration of mechanical ventilation, an expected average of 4 hrs
Measured: 24 hrs
Secondary outcomes (2)
Reduced incidence of postoperative respiratory complications
- Hypoxemia determined as partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO2/FiO2) < 300 mm Hg.
- Atelectases.
- Nosocomial (ventilator-associated) pneumonia.
- Hypoxemia determined as PaO2/FiO2 < 300 mm Hg.
- Atelectases.
- Nosocomial (ventilator-associated) pneumonia. Hypoxemia determined as PaO2/FiO2 < 300 mm Hg, atelectases, • Nosocomial (ventilator-associated) pneumonia.
Measured: up to 28 days postoperatively
Duration of intensive care unit stay
Participants will be followed for the duration of the ICU stay, an expected average of 48 hrs
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mikhail Y. Kirov, Northern State Medical University
- Investigators
- Mikhail Y KIrov, MD, PhD, Principal investigator, Northern State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524522
- Sponsor's protocol ID
- WEAN-IPI
- Acronym
- WEAN-IPI
- Status last verified
- Apr 2016
- First submitted
- 4 Aug 2015
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Pulmonary Recruitment and Postoperative Monitoring of Integrated Pulmonary Index in Off-pump Coronary Bypass Grafting
- ClinicalTrials.gov ID
- NCT02524522
- Acronym / sponsor ID
- WEAN-IPI / WEAN-IPI
- Keywords
- Integrated Pulmonary Index, automated protocol-driven weaning, pulmonary recruitment maneuver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Northern State Medical UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 14 Aug 2015 (estimated)
- 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.
This study evaluates the influence of alveolar recruitment maneuver, protocolized liberation from respiratory support and monitoring of Integrated Pulmonary Index on the duration of the mechanical ventilation and the number of pulmonary complications in the early postoperative period after cardiac surgery.
Detailed description
The outcome of elective off-pump coronary artery bypass grafting (OPCAB) can be significantly compromised due to early postoperative pulmonary complications. The risk of pulmonary complications including acute respiratory distress syndrome (ARDS), atelectases, and early ventilator-associated pneumonia remains inappropriate. Therefore, the maneuvers improving pulmonary aeration and the early restoration of spontaneous breathing activity can be of clinical value. Protocol-driven liberation from mechanical ventilation (CMV) can decrease the duration of CMV as well as the number of pulmonary complications. INTELLiVENT-Assisted spontaneous ventilation (INTELLiVENT-ASV) is a new approach, that may be as effective as conventional protocol-driven liberation from CMV.
In parallel, the thorough postoperative monitoring of pulmonary function during both postoperative mechanical ventilation and spontaneous breathing is also of a great value. One of the novel approaches to respiratory monitoring is Integrated Pulmonary Index (IPI). The Integrated Pulmonary Index merges four vital parameters including end-tidal carbon dioxide (EtCO2), respiratory rate, pulse rate, and oxygen saturation (SpO2) measured by capnography and pulse oximetry into a single index value utilizing fuzzy logic model .
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INTELLiVENT-ASV mode | Active comparator | Device: INTELLiVENT-ASV modeActive comparator: Discontinuation of mechanical ventilation in postoperative period will be provided using automatically driven mode - INTELLiVENT-ASV. In the INTELLiVENT-ASV mode target EtCO2 will be 30-35 mm Hg, target SpO2 - 94-98%, quick wean option - activated. |
| SIMV mode | Active comparator | Device: SIMV modeActive comparator: Discontinuation from mechanical ventilation in postoperative period will be provided using physician driven protocol. The synchronized intermittent mandatory ventilation (SIMV) mode settings will be as follows: PEEP 5 cm of water, FiO2 to achieve SpO2 > 94 %. Inspiratory pressure will be adjusted to deliver a tidal volume (VT) of 8 mL/kg predicted body weight; pressure support will be 2 cm of water higher. Respiratory rate (RR) will be adjusted to provide EtCO2 of 30-35 mm Hg. Respiratory rate and inspiratory pressure will be decreased gradually every 30 minutes. After decrease of inspiratory pressure to 6 cm of water (8 cm of water in case of BMI > 30 kg/m2) and respiratory rate to 6/min, the spontaneous breathing trial (SBT) will be started. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Informed consent.
- Elective OPCAB.
Key exclusion criteria (5 listed)
- Participation in any other study.
- Morbid obesity (BWI > 40).
- The risk of pneumothorax after alveolar recruitment due to pulmonary emphysema.
- Constant atrial fibrillation with pulse rate exceeding 100/min.
- Inability to breathe easily through the nostrils and thus to gain good quality EtCO2 readings while breathing spontaneously, due to chronic rhinitis.
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 |
|---|---|---|
| INTELLiVENT-ASV modeDiscontinuation with INTELLiVENT-ASV mode: discontinuation from mechanical ventilation in the early postoperative period will be provided by quick-wean option of INTELLiVENT-ASV mode | Device | INTELLiVENT-ASV mode |
| SIMV modeDiscontinuation with SIMV mode: discontinuation with SIMV mode: discontinuation from mechanical ventilation in the early postoperative period will be provided in SIMV mode using physician driven algorithm | Device | SIMV mode |
Primary outcome
Duration of postoperative mechanical ventilation
Time frame: 24 hrs
Participants will be followed for the duration of mechanical ventilation, an expected average of 4 hrs
2 secondary outcomes
Reduced incidence of postoperative respiratory complications
Time frame: up to 28 days postoperatively
Duration of intensive care unit stay
Time frame: 72 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 6 Apr 2016.
- Feasibility study on full closed-loop control ventilation (IntelliVent-ASV™) in ICU patients with acute respiratory failure: a prospective observational comparative studyLink provided by the sponsor.
- 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.
Mikhail Y KIrov, MD, PhD principal investigator
Northern State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INTELLiVENT-ASV mode and SIMV mode in people with Mechanical Ventilation Complication and Postoperative Pulmonary Atelectasis, run by Northern State Medical University 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 2 inclusion and 5 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 6 Apr 2016. 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?
Duration of postoperative mechanical ventilation (time frame: 24 hrs). 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 6 Apr 2016.