Ventilator-Induced Lung InjuryNCT04815733
Pressure Support Ventilation During Laparoscopic and Abdominal Robotic Surgery.
A study testing Mandatory ventilation and pressure support ventilation in people with Ventilator-Induced Lung Injury, run by Moscow Clinical Scientific Center at 1 site in Russia.
Trial summary
This study is a single-center, blind, prospective, randomized, controlled trial of pressure support ventilation (PSVpro) versus pressure control ventilation - volume guaranteed (PCV - VG) during laparoscopic and robotic abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ventilator-Induced Lung Injury
- What is being tested?
- Mandatory ventilation and pressure support ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jun 2017to 31 Mar 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written consent.
- Men and women aged 18 years or more.
- The physical status from ASA classification I, II or III.
- BMI <= 34.9 kg / m2.
- Low risk of respiratory complications.
- Laparoscopic surgery in the pelvis.
Who cannot join
- The physical status from ASA IV or V.
- BMI> = 35 kg / m2.
- Neuromuscular disease.
- Allergy to Anesthetic Agents.
- Operations on two cavities.
- Operations on the chest cavity.
Trial locations and contacts
1 site in 1 country.
About this study
This study is a single-center, blind, prospective, randomized, controlled trial of pressure support ventilation (PSVpro) versus pressure control ventilation - volume guaranteed (PCV - VG) during laparoscopic and robotic abdominal surgery.
Read the detailed description
The objective of the study to evaluate the possibility and feasibility of using PSVpro during anesthesia during long-term laparoscopic and robot-assisted abdominal operations at different levels of neuromuscular block.
Intervention: We plan to include 100 patients who will undergo elective long (more 2 hours) laparoscopic or abdominal robotic surgery. All patients will be randomly assigned in two groups in ratio 1:1. 1 group- deep neuromuscular block and mandatory ventilation; 2 group- partial neuromuscular block and pressure support ventilation.
Expected Results. PSV may reduce the systemic inflammatory response compared to the mandatory ventilation during laparoscopic and abdominal robotic surgery.
- Conditions
- Ventilator-Induced Lung Injury
- Being tested
- Mandatory ventilation, pressure support ventilation
- Keywords
- pressure support ventilation, anaesthesia, lung injury, laparoscopic surgery
- Medical subject headings
- Ventilator-Induced Lung Injury, Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandatory ventilationProcedure or surgery
Use PCV-VG
pressure support ventilationProcedure or surgery
Use PSVpro
| Study group | Role | What they receive |
|---|---|---|
| Mandatory ventilation | Active comparator | deep neuromuscular block and mandatory ventilation (PCV-VG); Receives: Procedure: Mandatory ventilation |
| Pressure support ventilation | Experimental | partial neuromuscular block and pressure support ventilation (PSVpro). Receives: Procedure: pressure support ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentrations of biomarkers of lung injury
Measure concentration of Interleukin-6 (IL-6), Interleukin-8 (IL-8), tumor necrosis factor receptor I / II (sTNF rI / II)) in blood serum
Measured: 1-3 hours after surgery
Secondary outcomes (2)
Maximum intraoperative lactate level in the early postoperative period
Maximum intraoperative lactate level
Measured: 1 hour after surgery
The maximum level of vasopressor support during surgery
Norepinephrine consumption (mcg/kg/h)
Measured: From time of skin incision to time of skin closure assessed up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start1 Jun 2017
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator-Induced Lung InjuryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- t is planned to recruit patients in two groups: group 1-patients who will undergo General anesthesia with deep neuromuscular block and PCV-VG; group 2-patients with partial neuromuscular block and PSVpro. Randomization of patients into two 1:1 groups will be performed by random number generation.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moscow Clinical Scientific Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valerii Subbotin, Moscow Clinical Scientific Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815733
- Sponsor's protocol ID
- MoscowCSC
- Status last verified
- Apr 2023
- First submitted
- 28 Oct 2020
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressure Support Ventilation During Laparoscopic and Abdominal Robotic Surgery.
- ClinicalTrials.gov ID
- NCT04815733
- Acronym / sponsor ID
- MoscowCSC
- Conditions
- Ventilator-Induced Lung Injury
- Keywords
- pressure support ventilation, anaesthesia, lung injury, laparoscopic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Moscow Clinical Scientific CenterUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 25 Mar 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.
This study is a single-center, blind, prospective, randomized, controlled trial of pressure support ventilation (PSVpro) versus pressure control ventilation - volume guaranteed (PCV - VG) during laparoscopic and robotic abdominal surgery.
Detailed description
The objective of the study to evaluate the possibility and feasibility of using PSVpro during anesthesia during long-term laparoscopic and robot-assisted abdominal operations at different levels of neuromuscular block.
Intervention: We plan to include 100 patients who will undergo elective long (more 2 hours) laparoscopic or abdominal robotic surgery. All patients will be randomly assigned in two groups in ratio 1:1. 1 group- deep neuromuscular block and mandatory ventilation; 2 group- partial neuromuscular block and pressure support ventilation.
Expected Results. PSV may reduce the systemic inflammatory response compared to the mandatory ventilation during laparoscopic and abdominal robotic surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- t is planned to recruit patients in two groups: group 1-patients who will undergo General anesthesia with deep neuromuscular block and PCV-VG; group 2-patients with partial neuromuscular block and PSVpro. Randomization of patients into two 1:1 groups will be performed by random number generation.
| Arm | Type | Receives |
|---|---|---|
| Mandatory ventilation | Active comparator | Procedure: Mandatory ventilationdeep neuromuscular block and mandatory ventilation (PCV-VG); |
| Pressure support ventilation | Experimental | Procedure: pressure support ventilationpartial neuromuscular block and pressure support ventilation (PSVpro). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written consent.
- Men and women aged 18 years or more.
- The physical status from ASA classification I, II or III.
- BMI <= 34.9 kg / m2.
- Low risk of respiratory complications.
Key exclusion criteria (6 listed)
- The physical status from ASA IV or V.
- BMI> = 35 kg / m2.
- Neuromuscular disease.
- Allergy to Anesthetic Agents.
- Operations on two cavities.
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 |
|---|---|---|
| Mandatory ventilationUse PCV-VG | Procedure or surgery | Mandatory ventilation |
| pressure support ventilationUse PSVpro | Procedure or surgery | Pressure support ventilation |
Primary outcome
Concentrations of biomarkers of lung injury
Time frame: 1-3 hours after surgery
Measure concentration of Interleukin-6 (IL-6), Interleukin-8 (IL-8), tumor necrosis factor receptor I / II (sTNF rI / II)) in blood serum
2 secondary outcomes
Maximum intraoperative lactate level in the early postoperative period
Time frame: 1 hour after surgery
The maximum level of vasopressor support during surgery
Time frame: From time of skin incision to time of skin closure assessed up to 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 26 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandatory ventilation and pressure support ventilation in people with Ventilator-Induced Lung Injury, run by Moscow Clinical Scientific Center 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 6 inclusion and 6 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 26 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?
Concentrations of biomarkers of lung injury (time frame: 1-3 hours after surgery). 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 26 Apr 2023.