High-risk Lung Resection SurgeryAEGISNCT06156943
Advanced Goal-Directed Impedancemetry Strategy for Lung Resection Surgery
A study testing individualized goal-directed fluid therapy by Starling device in people with High-risk Lung Resection Surgery, run by Hospices Civils de Lyon at 10 sites in France.
Trial summary
High-risk patients scheduled for lung resection surgery are increasing and theoretically eligible to perioperative individualized goal-directed fluid therapy (GDFT). However, thoracic surgery is challenging for intraoperative stroke volume (SV) and/or cardiac output monitoring because it requires lateral positioning… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- High-risk Lung Resection Surgery
- What is being tested?
- individualized goal-directed fluid therapy by Starling device
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 722 participants
- Where
- 10 sitesFrance
- Study dates
- 12 Dec 2024to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥ 18 years old)
- High-risk patients (ASA score ≥ 3 and/or ventilatory deficit (defined as FEV1≤70% and/or VC≤70%) and/or AKI risk index ≥ III and/or modified clinical Lee Criteria ≥2) undergoing elective open-chest or video-assisted or robotic lung resection surgery
- Patients who have provided written informed consent to participate in the study
- Patients affiliated with a social health insurance
Who cannot join
- Pleural or mediastinal resection surgery
- Emergency surgery (Less than 24h)
- Patients unable to understand the purpose of the study
- Patients participating in another trial that would interfere with this study
- Female patients who are pregnant, lactating or women of child-bearing potential without effective methods of contraception
- Female patients with positive β-HCG blood test
- Patients under judicial protection (guardianship, curatorship)
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
France10 sites, 10 recruiting
- Recruiting
Hopital Louis Pradel
Bron, 69500
FELLAHI Jean-Luc, MD. PhD, +33-472118933, jean-luc.fellahi@chu-lyon.fr
- Recruiting
CHU Dijon Bourgogne
Dijon, 21000
Guinot Pierre, MD
- Recruiting
Hôpital Arnaud de Villeneuve - CHU Montpellier
Montpellier, 34090
Godard Philippe, MD
- Recruiting
Chu Nancy
Nancy
GUERCI PHILIPPE, +33 3 83 85 18 13, p.guerci@chru-nancy.fr
- Recruiting
Hôpital Européen Georges Pompidou
Paris, 75015
Bernard Cholley, MD
- Recruiting
Hopital du Haut-Leveque - CHU Bordeaux
Pessac, 33600
Ouattara Alexandre, MD
- Recruiting
CHU de Rennes
Rennes, 35033
Nesseler Nicolas, MD
- Recruiting
CHU Nantes
Saint-Herblain, 44800
Bertrand Rozec, MD
- Recruiting
CHU Strasbourg
Strasbourg, 67000
Michel Mertes, MD
- Recruiting
Chu Toulouse
Toulouse
LABASTE François, MD, +33 5 61 32 27 91, labaste.f@chu-toulouse.fr
About this study
Official title: Advanced Goal-Directed Impedancemetry Strategy for Lung Resection Surgery : a Multicenter, Randomized, Controlled Trial (AEGIS Study)
High-risk patients scheduled for lung resection surgery are increasing and theoretically eligible to perioperative individualized goal-directed fluid therapy (GDFT). However, thoracic surgery is challenging for intraoperative stroke volume (SV) and/or cardiac output monitoring because it requires lateral positioning, one-lung ventilation, and open-chest condition. Pulse contour analysis and esophageal Doppler have been proposed with contrasting results, whereas dynamic indices have been shown useless for predicting fluid responsiveness in that specific setting. Besides, more invasive technologies like thermodilution are not routinely used at the bedside by careproviders.
Chest bioreactance seems to be a feasible, safe, rustic, easy-to-use, and plug-and-play method to non-invasively and continuously monitor SV and cardiac output in thoracic cancer surgery patients, able to detect significant spontaneous and pharmacologically-induced changes over time. The impact of chest bioreactance on patients 'outcome remains however to be demonstrated.
Read more
Indeed, the routine fluid management in patients undergoing lung resection surgery could be responsible of hypovolemia/hypoperfusion and/or hypervolemia/congestion leading to postoperative complications.
The present national prospective multicenter randomized simple blind study aims to demonstrate that an individualized goal-directed fluid therapy (GDFT) driven by chest bioreactance improves outcomes within 30 days in lung resection surgery patients when compared with a standard of care. As double blind is not possible, an adjudication committee, whose members will be unaware of the procedure assignments, will adjudicate all the clinical outcomes.
- Conditions
- High-risk Lung Resection Surgery
- Being tested
- individualized goal-directed fluid therapy by Starling device, group managed by standard of care
- Keywords
- goal-directed fluid therapy, Chest bioreactance, lung resection surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individualized goal-directed fluid therapy by Starling deviceProcedure or surgery
For patients in optimized group, fluids will be managed by Starling device during the lung resection surgery.
group managed by standard of careProcedure or surgery
Patients will be managed intraoperatively at the discretion of the attending anesthesiologists, in accordance with their institutional protocols
| Study group | Role | What they receive |
|---|---|---|
| Optimized group managed by the Starling device | Experimental | In the optimized group, patients will be managed intraoperatively with the Starling device according to the Société Française d'Anesthésie Réanimation 2024 GDFT protocol (Alter C. https://sfar.org/optimisation-hemodynamique-perioperatoire-adulte-dont-obstetrique/). It is a non-invasive fluid management monitoring system provides continuous hemodynamic monitoring and empowers fluid management across the continuum of care. Thanks to this device, patients will be managed according to the following protocol: fluid responsiveness will be systematically assessed after anesthetic induction and throughout the procedure as soon as the basal SV monitored by the Starling device decrease by at least 10%. To do so, repetitive fluid challenges (200 ± 50 ml of cristalloids) will be quickly delivered until SV stops to increase by 10% or more. Vasoactive and/or inotropic agents will be used at the discretion of the attending anesthesiologists in case of fluid unresponsiveness. Receives: Procedure: individualized goal-directed fluid therapy by Starling device |
| Control group managed by standard of care | Other | In the control group, patients will be managed intraoperatively at the discretion of the attending anesthesiologists, in accordance with their institutional protocols (i.e. fluids and/or vasoactive agents are given to maintain mean arterial pressure ≥ 65 mmHg). Receives: Procedure: group managed by standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite of postoperative complications rate adapted from the Clavien-Dindo classification with only events ≥ class II
It will be performed in each group and assessed by an independent adjudication committee.
Clavien-Dindo classification :
Class II :
- Pulmonary complications (any infection requiring antibiotics, non-invasive ventilation)
- Cardiovascular complications (postoperative atrial fibrillation (POAF) requiring treatment, deep venous thrombosis)
- Renal complications (acute kidney injury (AKI), defined as an increase of serum creatinine of more than 50% or more than 26.5 µmol/L, requiring fluid supply or diuretics)
- Cerebral complications (delirium requiring treatment, stroke)
- Blood products transfusion Class III
- Reoperation from any cause Class IV
- Any unscheduled admission to the intensive care unit (ICU) Class V
- Mortality from any cause The analysis of the main endpoint will be performed by a mixed logistic regression model. It will take into account as explanatory variable the intervention, as well as the type of surgery (open-chest or video-assisted or robotic). It will include
Measured: Within 30 days after the surgery
Secondary outcomes (10)
Each item of the primary composite endpoint between both groups
Items of the primary composite endpoint :
- Pulmonary complications rate
Each item of the primary composite endpoint will be described in each group in terms of number/percentage of patients and compared using the chi-2 test or the exact test of Fisher. An Holm correction will be applied to take into account multiple testing.
Measured: Within 30 days after the surgery
Each item of the primary composite endpoint between both groups
Items of the primary composite endpoint :
- Cardiovascular complications rate
Each item of the primary composite endpoint will be described in each group in terms of number/percentage of patients and compared using the chi-2 test or the exact test of Fisher. An Holm correction will be applied to take into account multiple testing.
Measured: Within 30 days after the surgery
Each item of the primary composite endpoint between both groups
Items of the primary composite endpoint :
- Renal complications rate
Each item of the primary composite endpoint will be described in each group in terms of number/percentage of patients and compared using the chi-2 test or the exact test of Fisher. An Holm correction will be applied to take into account multiple testing.
Measured: Within 30 days after the surgery
Each item of the primary composite endpoint between both groups
Items of the primary composite endpoint :
- Cerebral complications rate
Each item of the primary composite endpoint will be described in each group in terms of number/percentage of patients and compared using the chi-2 test or the exact test of Fisher. An Holm correction will be applied to take into account multiple testing.
Measured: Within 30 days after the surgery
Each item of the primary composite endpoint between both groups
Items of the primary composite endpoint :
- Blood products transfusion rate
Each item of the primary composite endpoint will be described in each group in terms of number/percentage of patients and compared using the chi-2 test or the exact test of Fisher. An Holm correction will be applied to take into account multiple testing.
Measured: Within 30 days after the surgery
Each item of the primary composite endpoint between both groups
Items of the primary composite endpoint :
- Reoperation from any cause rate
Each item of the primary composite endpoint will be described in each group in terms of number/percentage of patients and compared using the chi-2 test or the exact test of Fisher. An Holm correction will be applied to take into account multiple testing.
Measured: Within 30 days after the surgery
Each item of the primary composite endpoint between both groups
Items of the primary composite endpoint :
- Any admission to the ICU rate
Each item of the primary composite endpoint will be described in each group in terms of number/percentage of patients and compared using the chi-2 test or the exact test of Fisher. An Holm correction will be applied to take into account multiple testing.
Measured: Within 30 days after the surgery
Each item of the primary composite endpoint between both groups
Items of the primary composite endpoint :
- Mortality rate
Each item of the primary composite endpoint will be described in each group in terms of number/percentage of patients and compared using the chi-2 test or the exact test of Fisher. An Holm correction will be applied to take into account multiple testing.
Measured: Within 30 days after the surgery
Length of stay in hospital (days) and number/percentage of patients with length of stay in hospital ≥ 5 days in each group
Quantitative secondary endpoints will be described in each group, and will be compared between the two groups using the t test of Student or the test of Mann and Whitney, according to the shape of the distribution.
Qualitative secondary outcome will be described in each group by the number/percentage of patients and compared using the chi-2 test or the exact test of Fisher.
Measured: 5 days
APGAR surgical score and number/percentage of patients with APGAR surgical score < 7 in each group
Quantitative secondary endpoints will be described in each group, and will be compared between the two groups using the t test of Student or the test of Mann and Whitney, according to the shape of the distribution.
Qualitative secondary outcome will be described in each group by the number/percentage of patients and compared using the chi-2 test or the exact test of Fisher.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start12 Dec 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-risk Lung Resection SurgeryStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- National prospective multicenter randomized simple blind controlled study comparing a standard of care (control group) to an individualized strategy of intraoperative GDFT driven by non-invasive continuous SV monitoring via chest bioreactance (optimized group).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 722 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156943
- Sponsor's protocol ID
- 69HCL22_1133
- Other IDs
- 2024-A01843-44
- Acronym
- AEGIS
- Status last verified
- Dec 2024
- First submitted
- 20 Nov 2023
- Last updated
- 24 Dec 2024
- 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 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Goal-Directed Impedancemetry Strategy for Lung Resection Surgery : a Multicenter, Randomized, Controlled Trial (AEGIS Study)
- ClinicalTrials.gov ID
- NCT06156943
- Acronym / sponsor ID
- AEGIS / 69HCL22_1133
- Conditions
- High-risk Lung Resection Surgery
- Keywords
- goal-directed fluid therapy, Chest bioreactance, lung resection surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 722 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 5 Dec 2023 (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.
High-risk patients scheduled for lung resection surgery are increasing and theoretically eligible to perioperative individualized goal-directed fluid therapy (GDFT). However, thoracic surgery is challenging for intraoperative stroke volume (SV) and/or cardiac output monitoring because it requires lateral positioning, one-lung ventilation, and open-chest condition. Pulse contour analysis and esophageal Doppler have been proposed with contrasting results, whereas dynamic indices have been shown useless for predicting fluid responsiveness in that specific setting. Besides, more invasive technologies like thermodilution are not routinely used at the bedside by careproviders.
Chest bioreactance seems to be a feasible, safe, rustic, easy-to-use, and plug-and-play method to non-invasively and continuously monitor SV and cardiac output in thoracic cancer surgery patients, able to detect significant spontaneous and pharmacologically-induced changes over time. The impact of chest bioreactance on patients 'outcome remains however to be demonstrated.
Indeed, the routine fluid management in patients undergoing lung resection surgery could be responsible of hypovolemia/hypoperfusion and/or hypervolemia/congestion leading to postoperative complications.
The present national prospective multicenter randomized simple blind study aims to demonstrate that an individualized goal-directed fluid therapy (GDFT) driven by chest bioreactance improves outcomes within 30 days in lung resection surgery patients when compared with a standard of care. As double blind is not possible, an adjudication committee, whose members will be unaware of the procedure assignments, will adjudicate all the clinical outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- National prospective multicenter randomized simple blind controlled study comparing a standard of care (control group) to an individualized strategy of intraoperative GDFT driven by non-invasive continuous SV monitoring via chest bioreactance (optimized group).
| Arm | Type | Receives |
|---|---|---|
| Optimized group managed by the Starling device | Experimental | Procedure: individualized goal-directed fluid therapy by Starling deviceIn the optimized group, patients will be managed intraoperatively with the Starling device according to the Société Française d'Anesthésie Réanimation 2024 GDFT protocol (Alter C. https://sfar.org/optimisation-hemodynamique-perioperatoire-adulte-dont-obstetrique/). It is a non-invasive fluid management monitoring system provides continuous hemodynamic monitoring and empowers fluid management across the continuum of care. Thanks to this device, patients will be managed according to the following protocol: fluid responsiveness will be systematically assessed after anesthetic induction and throughout the procedure as soon as the basal SV monitored by the Starling device decrease by at least 10%. To do so, repetitive fluid challenges (200 ± 50 ml of cristalloids) will be quickly delivered until SV stops to increase by 10% or more. Vasoactive and/or inotropic agents will be used at the discretion of the attending anesthesiologists in case of fluid unresponsiveness. |
| Control group managed by standard of care | Other | Procedure: group managed by standard of careIn the control group, patients will be managed intraoperatively at the discretion of the attending anesthesiologists, in accordance with their institutional protocols (i.e. fluids and/or vasoactive agents are given to maintain mean arterial pressure ≥ 65 mmHg). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (≥ 18 years old)
- High-risk patients (ASA score ≥ 3 and/or ventilatory deficit (defined as FEV1≤70% and/or VC≤70%) and/or AKI risk index ≥ III and/or modified clinical Lee Criteria ≥2) undergoing elective open-chest or video-assisted or robotic lung resection surgery
- Patients who have provided written informed consent to participate in the study
- Patients affiliated with a social health insurance
Key exclusion criteria (7 listed)
- Pleural or mediastinal resection surgery
- Emergency surgery (Less than 24h)
- Patients unable to understand the purpose of the study
- Patients participating in another trial that would interfere with this study
- Female patients who are pregnant, lactating or women of child-bearing potential without effective methods of contraception
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 |
|---|---|---|
| individualized goal-directed fluid therapy by Starling deviceFor patients in optimized group, fluids will be managed by Starling device during the lung resection surgery. | Procedure or surgery | Optimized group managed by the Starling device |
| group managed by standard of carePatients will be managed intraoperatively at the discretion of the attending anesthesiologists, in accordance with their institutional protocols | Procedure or surgery | Control group managed by standard of care |
Primary outcome
A composite of postoperative complications rate adapted from the Clavien-Dindo classification with only events ≥ class II
Time frame: Within 30 days after the surgery
It will be performed in each group and assessed by an independent adjudication committee. Clavien-Dindo classification : Class II : * Pulmonary complications (any infection requiring antibiotics, non-invasive ventilation) * Cardiovascular complications (postoperative atrial fibrillation (POAF) requiring treatment, deep venous thrombosis) * Renal complications (acute kidney injury (AKI), defined as an increase of serum creatinine of more than 50% or more than 26.5 µmol/L, requiring fluid supply or diuretics) * Cerebral complications (delirium requiring treatment, stroke) * Blood products transfusion Class III * Reoperation from any cause Class IV * Any unscheduled admission to the intensive care unit (ICU) Class V * Mortality from any cause The analysis of the main endpoint will be performed by a mixed logistic regression model. It will take into account as explanatory variable the intervention, as well as the type of surgery (open-chest or video-assisted or robotic). It will include
10 secondary outcomes
Each item of the primary composite endpoint between both groups
Time frame: Within 30 days after the surgery
Each item of the primary composite endpoint between both groups
Time frame: Within 30 days after the surgery
Each item of the primary composite endpoint between both groups
Time frame: Within 30 days after the surgery
Each item of the primary composite endpoint between both groups
Time frame: Within 30 days after the surgery
Each item of the primary composite endpoint between both groups
Time frame: Within 30 days after the surgery
Each item of the primary composite endpoint between both groups
Time frame: Within 30 days after the surgery
Each item of the primary composite endpoint between both groups
Time frame: Within 30 days after the surgery
Each item of the primary composite endpoint between both groups
Time frame: Within 30 days after the surgery
Length of stay in hospital (days) and number/percentage of patients with length of stay in hospital ≥ 5 days in each group
Time frame: 5 days
APGAR surgical score and number/percentage of patients with APGAR surgical score < 7 in each group
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- 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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing individualized goal-directed fluid therapy by Starling device in people with High-risk Lung Resection Surgery, run by Hospices Civils de Lyon at 10 sites in France.
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 7 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: looking for participants now, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact FELLAHI Jean-Luc, M.D., Ph.D., ((+33) 4 72 11 89 33, jean-luc.fellahi@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite of postoperative complications rate adapted from the Clavien-Dindo classification with only events ≥ class II (time frame: Within 30 days after the 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 24 Dec 2024.