Mechanical Ventilation ComplicationFCV-IMPALANCT06256900
Flow Controlled Ventilation in Robot-assisted Laparoscopic Surgery
A study of Mechanical Ventilation Complication and Postoperative Pulmonary Atelectasis, run by Cantonal Hospital of St. Gallen.
Trial summary
The optimization of ventilation is especially important during general anaesthesia, when active, physiologic respiration suspends and is replaced by non-physiologic mechanical positive pressure ventilation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mechanical Ventilation Complication, Postoperative Pulmonary Atelectasis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 29 Oct 2024to 29 Oct 2024
- 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
- Patient undergoing elective robot-assisted laparoscopic surgery (either abdominal, urologic or gynecologic surgery) with a duration of expected ventilation of ≥ 90 minutes
- Male or female aged ≥ 18 years
- ASA Physical Status Classification System score I - III
- Must be willing and able to give written informed consent to participate in the study and agree to comply with the study protocol prior to initiation of any study-mandated procedure and study intervention
Who cannot join
- Patient with weight < 40 kg ideal body weight
- ASA Physical Status Classification System score IV - VI
- Previous enrolment into the current study
- Enrolment of study investigator, his/her family members, employees and other dependent persons
- If female and of childbearing potential: known pregnancy or a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
About this study
Official title: Flow Controlled Ventilation to Improve Postoperative Pulmonary Outcome After Robot-assisted Laparoscopic Surgery - a Prospective, Randomised, Single-blinded, Controlled and Single-centre Investigation
The optimization of ventilation is especially important during general anaesthesia, when active, physiologic respiration suspends and is replaced by non-physiologic mechanical positive pressure ventilation. Aiming at preserving compliance of lung tissue to guarantee an effective gas exchange is to avoid an excessive pressure application, especially in extreme positioning of the patient (Trendelenburg positioning) and/or pneumoperitoneum resulting in additional non-physiologic intrathoracic pressure. Perioperative lung protection strategies have steadily improved in recent years to reduce complications from mechanical ventilation, but postoperative pulmonary complications remain a risk factor for increased morbidity and mortality.
Read the detailed description
Mechanical ventilation is crucial during general anesthesia, with ongoing efforts to refine strategies for optimal respiratory support. Important articles on perioperative ventilation explored key aspects, including PEEP application, tidal volume effects, PPC after major surgeries, and perioperative oxygen titration to mitigate oxidative stress. PEEP plays a pivotal role in enhancing oxygenation and preventing atelectasis during mechanical ventilation. Landmark studies by the ARDS Network highlight the importance of customizing PEEP application. This tailored approach not only improves respiratory mechanics but also reduces the risk of barotrauma, underscoring the crucial impact of personalized PEEP strategies. Concurrently, adopting a lung-protective strategy with low tidal volumes, has proven effective in mitigating ventilator-induced lung injury. These strategies aim to strike a balance between optimal oxygenation and minimizing potential complications associated with mechanical ventilation. Despite advancements in perioperative care, PPC remain a concern, particularly following major surgical procedures. Recent investigations emphasize the multifactorial nature of these complications. Early identification of risk factors and meticulous monitoring are crucial to reducing the incidence of complications such as atelectasis, pneumonia, and respiratory insufficiency. Understanding the interplay between mechanical ventilation strategies and postoperative outcomes is essential for improving patient recovery. The pursuit of optimal oxygenation must be balanced against the potential for oxygen toxicity and oxidative stress. Available studies shed light on the delicate equilibrium required in maintaining adequate oxygen delivery while avoiding the detrimental effects of hyperoxia. Clinicians must consider individual patient factors and tailor oxygen therapy to prevent oxidative stress, which can contribute to tissue damage and compromise overall patient well-being. FCV is a new ventilation strategy designed to minimize the mechanical effects of perioperative ventilation on lung tissue. Compared to traditionally employed ventilation strategies, gas flow is controlled during both inspiration and expiration in FCV. In particular, the almost linear pressure drop during the expiratory phase of FCV has been shown in various ex vivo/experimental and clinical studies to improve gas exchange and the proportion of ventilated lung tissue.
Ongoing advancements in mechanical ventilation shape anesthesia practices with a focus on evidence-based approaches for patient safety. Building on prior findings, this study explores the benefits of the novel ventilation approach, FCV, aiming to reduce dissipative energy and alveolar stress. The investigators hypothesize positive impacts on perioperative ventilation, vital parameters, and a decreased incidence of PPC, contributing to overall postoperative morbidity and mortality reduction.
- Being tested
- Flow-controlled ventilation, Pressure-controlled ventilation
- Keywords
- Flow-controlled ventilation, Postoperative pulmonary complications, electrical impedance tomography
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow-controlled ventilationOther
Also called FCV
FCV mode during robot-assisted laparoscopic surgery
Pressure-controlled ventilationOther
Also called PCV
PCVmode during robot-assisted laparoscopic surgery
| Study group | Role | What they receive |
|---|---|---|
| Flow-controlled ventilation | Experimental | Experimental intervention FCV (EVONE, Ventinova Medical): PEEP and Peak inspiratory pressure titration guided by dynamic compliance. Receives: Other: Flow-controlled ventilation |
| Pressure-controlled ventilation | Active comparator | Control intervention PCV (Dräger Medical, Atlan A350): lung-protective ventilation to current best practice. Settings determined by the attending anesthesiologist (based on the internal SOP: intraoperative ventilation in robot-assisted laparoscopic surgery). Receives: Other: Pressure-controlled ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in the number of patients developing postoperative pulmonary complications
Development of PPC (composite endpoint including pneumonia, bronchospasm, atelectasis, pulmonary congestion, respiratory failure, pleural effusion, pneumothorax, requirement for mechanical ventilation) within the first 5 postoperative days (or until discharge).
- Constant postoperative monitoring of clinical features indicating PPC
- EIT parameters indicating atelectasis (defined by EIT derived parameters Global Inhomogenity Index, Tidal Impedance Variation, end-expiratory lung impedance) measurement after arrival at the PACU.
- Requirement of additional oxygen will be evaluated after transfer to the PACU/ICU. Air test indicating additional oxygen requirement, SpO2 <90% / <88% in case of risk of hypercapnic respiratory failure.
- If unplanned and continued mechanical ventilation is required after surgery this will count as fulfilled primary endpoint.
Measured: to postoperative day 5/discharge
Secondary outcomes (6)
Differences in Clara-Cell 16 serum concentrations
Presence and increase of blood biomarkers indicating alveolar shear stress compared between groups. Blood samples will be required to determine CC16 (3x during the course of the study, approx. 5ml blood each).
- Baseline (during preoperative anaesthesia consultation or during preparations before induction of anaesthesia
- During intervention: ca. 60 minutes after final adjustments of Trendelenburg positioning/pneumoperitoneum
- After transfer to PACU/ICU respectively
Measured: periprocedural
Differences in area under the curve of postoperative modified Horovitz index
maximal area under the curve of SpO2/FiO2 compared between groups during first hour after surgery/arrival at the PACU. Derived from data recorded in the electronic anesthesia protocol.
Measured: first hour after surgery
Differences in end-tidal to capillary/arterial CO2 gradient
Maximal end-tidal to capillary/arterial CO2 gradient compared between groups. (Capillary blood gases can accurately reflect arterial pH, pCO2 and Hb. Because arterial cannulation is not mandatory in the patient population, the investigators choose to determine the end-tidal to arterial CO2 gradient by assessing capillary blood gas, which has been shown to accurately reflect arterial CO2). Derived from data recorded in the electronic anesthesia protocol.
Measured: periprocedural
Differences in minimal required intraoperative FiO2 concentration
Minimal required intraoperative FiO2 to ensure an adequate perioperative oxygenation (defined as min. oximetric SpO2 of >94%). Derived from data recorded in the electronic anesthesia protocol.
Measured: periprocedural
Differences in parameters derived from the electrical impedance tomography
Comparison of spatial and regional ventilation patterns during intervention between groups. Comparison of respiratory system compliacen, end-expiratory lung volume between groups at baseline (before surgical procedures in supine position), during intervention (ca. 60 min after Trendelenburg/pneumoperitoneum) and after return to supine position/end of pneumoperitoneum.
Whether FCV has an influence on parameters visualized and measured by EIT, these data will be monitored and evaluated during (secondary outcome assessment) and after (primary outcome assessment) the intervention (measurements at: baseline - during intervention (60min after Trendelenburg/Pneumoperitoneum) - after Trendelenburg/Pneumoperitoneum - after arrival at PACU)
Measured: periprocedural
Differences in perioperative ventilation/oxygenation parameters
Differences in perioperative ventilation and oxygenation parameters (minimal FiO2, min/max. PEEP, min/max. compliance), compared between groups. Data derived from the electronic anesthesia protocol.
Measured: periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start29 Oct 2024
- Primary completion29 Oct 2024
- Study completion29 Oct 2024
Why it stopped: The preparation and execution of this study were discontinued due to a range of practical constraints. Including logistical and operational challenges that would have compromised the study's feasibility and effective and questioning reliable results.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, single-center study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Timur Yurttas, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256900
- Sponsor's protocol ID
- 2023-02285
- Other IDs
- 2023
- Acronym
- FCV-IMPALA
- Status last verified
- Aug 2024
- First submitted
- 29 Jan 2024
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flow Controlled Ventilation to Improve Postoperative Pulmonary Outcome After Robot-assisted Laparoscopic Surgery - a Prospective, Randomised, Single-blinded, Controlled and Single-centre Investigation
- ClinicalTrials.gov ID
- NCT06256900
- Acronym / sponsor ID
- FCV-IMPALA / 2023-02285
- Keywords
- Flow-controlled ventilation, Postoperative pulmonary complications, electrical impedance tomography
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The preparation and execution of this study were discontinued due to a range of practical constraints. Including logistical and operational challenges that would have compromised the study's feasibility and effective and questioning reliable results.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- 29 Oct 2024 (actual)
- Study completion
- 29 Oct 2024 (actual)
- First posted
- 13 Feb 2024 (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.
The optimization of ventilation is especially important during general anaesthesia, when active, physiologic respiration suspends and is replaced by non-physiologic mechanical positive pressure ventilation. Aiming at preserving compliance of lung tissue to guarantee an effective gas exchange is to avoid an excessive pressure application, especially in extreme positioning of the patient (Trendelenburg positioning) and/or pneumoperitoneum resulting in additional non-physiologic intrathoracic pressure. Perioperative lung protection strategies have steadily improved in recent years to reduce complications from mechanical ventilation, but postoperative pulmonary complications remain a risk factor for increased morbidity and mortality.
Detailed description
Mechanical ventilation is crucial during general anesthesia, with ongoing efforts to refine strategies for optimal respiratory support. Important articles on perioperative ventilation explored key aspects, including PEEP application, tidal volume effects, PPC after major surgeries, and perioperative oxygen titration to mitigate oxidative stress. PEEP plays a pivotal role in enhancing oxygenation and preventing atelectasis during mechanical ventilation. Landmark studies by the ARDS Network highlight the importance of customizing PEEP application. This tailored approach not only improves respiratory mechanics but also reduces the risk of barotrauma, underscoring the crucial impact of personalized PEEP strategies. Concurrently, adopting a lung-protective strategy with low tidal volumes, has proven effective in mitigating ventilator-induced lung injury. These strategies aim to strike a balance between optimal oxygenation and minimizing potential complications associated with mechanical ventilation. Despite advancements in perioperative care, PPC remain a concern, particularly following major surgical procedures. Recent investigations emphasize the multifactorial nature of these complications. Early identification of risk factors and meticulous monitoring are crucial to reducing the incidence of complications such as atelectasis, pneumonia, and respiratory insufficiency. Understanding the interplay between mechanical ventilation strategies and postoperative outcomes is essential for improving patient recovery. The pursuit of optimal oxygenation must be balanced against the potential for oxygen toxicity and oxidative stress. Available studies shed light on the delicate equilibrium required in maintaining adequate oxygen delivery while avoiding the detrimental effects of hyperoxia. Clinicians must consider individual patient factors and tailor oxygen therapy to prevent oxidative stress, which can contribute to tissue damage and compromise overall patient well-being. FCV is a new ventilation strategy designed to minimize the mechanical effects of perioperative ventilation on lung tissue. Compared to traditionally employed ventilation strategies, gas flow is controlled during both inspiration and expiration in FCV. In particular, the almost linear pressure drop during the expiratory phase of FCV has been shown in various ex vivo/experimental and clinical studies to improve gas exchange and the proportion of ventilated lung tissue.
Ongoing advancements in mechanical ventilation shape anesthesia practices with a focus on evidence-based approaches for patient safety. Building on prior findings, this study explores the benefits of the novel ventilation approach, FCV, aiming to reduce dissipative energy and alveolar stress. The investigators hypothesize positive impacts on perioperative ventilation, vital parameters, and a decreased incidence of PPC, contributing to overall postoperative morbidity and mortality reduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, controlled, single-center study
| Arm | Type | Receives |
|---|---|---|
| Flow-controlled ventilation | Experimental | Other: Flow-controlled ventilationExperimental intervention FCV (EVONE, Ventinova Medical): PEEP and Peak inspiratory pressure titration guided by dynamic compliance. |
| Pressure-controlled ventilation | Active comparator | Other: Pressure-controlled ventilationControl intervention PCV (Dräger Medical, Atlan A350): lung-protective ventilation to current best practice. Settings determined by the attending anesthesiologist (based on the internal SOP: intraoperative ventilation in robot-assisted laparoscopic surgery). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient undergoing elective robot-assisted laparoscopic surgery (either abdominal, urologic or gynecologic surgery) with a duration of expected ventilation of ≥ 90 minutes
- Male or female aged ≥ 18 years
- ASA Physical Status Classification System score I - III
- Must be willing and able to give written informed consent to participate in the study and agree to comply with the study protocol prior to initiation of any study-mandated procedure and study intervention
Key exclusion criteria (5 listed)
- Patient with weight < 40 kg ideal body weight
- ASA Physical Status Classification System score IV - VI
- Previous enrolment into the current study
- Enrolment of study investigator, his/her family members, employees and other dependent persons
- If female and of childbearing potential: known pregnancy or a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
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 |
|---|---|---|
| Flow-controlled ventilationAlso: FCVFCV mode during robot-assisted laparoscopic surgery | Other | Flow-controlled ventilation |
| Pressure-controlled ventilationAlso: PCVPCVmode during robot-assisted laparoscopic surgery | Other | Pressure-controlled ventilation |
Primary outcome
Differences in the number of patients developing postoperative pulmonary complications
Time frame: to postoperative day 5/discharge
Development of PPC (composite endpoint including pneumonia, bronchospasm, atelectasis, pulmonary congestion, respiratory failure, pleural effusion, pneumothorax, requirement for mechanical ventilation) within the first 5 postoperative days (or until discharge). * Constant postoperative monitoring of clinical features indicating PPC * EIT parameters indicating atelectasis (defined by EIT derived parameters Global Inhomogenity Index, Tidal Impedance Variation, end-expiratory lung impedance) measurement after arrival at the PACU. * Requirement of additional oxygen will be evaluated after transfer to the PACU/ICU. Air test indicating additional oxygen requirement, SpO2 <90% / <88% in case of risk of hypercapnic respiratory failure. * If unplanned and continued mechanical ventilation is required after surgery this will count as fulfilled primary endpoint.
6 secondary outcomes
Differences in Clara-Cell 16 serum concentrations
Time frame: periprocedural
Differences in area under the curve of postoperative modified Horovitz index
Time frame: first hour after surgery
Differences in end-tidal to capillary/arterial CO2 gradient
Time frame: periprocedural
Differences in minimal required intraoperative FiO2 concentration
Time frame: periprocedural
Differences in parameters derived from the electrical impedance tomography
Time frame: periprocedural
Differences in perioperative ventilation/oxygenation parameters
Time frame: periprocedural
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A study of Mechanical Ventilation Complication and Postoperative Pulmonary Atelectasis, run by Cantonal Hospital of St. Gallen.
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 4 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: withdrawn, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Differences in the number of patients developing postoperative pulmonary complications (time frame: to postoperative day 5/discharge). 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 24 Apr 2025.