ThoracicNICOLENCT04251637
Non Invasive Cardiac Output Evaluation With Starling SV for Lung Elective Surgery
An observational study of Thoracic and Surgery, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Intraoperative hemodynamic optimization decreases postoperative complications and length of stay in high risk patient. Therefore, continuous monitoring of cardiac output (Qc) is recommended to guide fluid management. Thoracic bio-reactance is a recent technique that allows cardiac output non-invasive monitoring. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Cardiac output monitoring with Starling SV.
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 25 Sep 2020to 13 Mar 2021
- Phase
- Observational
- 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
Study population: - Adult patients scheduled in Louis Pradel hospital operating theater (Lyon University Hospital) for elective Lung surgery (lobectomy, bilobectomy or pneumonectomy); by thoracotomy and / or thoracoscopy.
Who may be able to join
- Adult patients
- Scheduled in Louis Pradel hospital operating theater (Lyon University Hospital) for elective Lung surgery (lobectomy, bilobectomy or pneumonectomy); by thoracotomy and / or thoracoscopy.
- Having stated their non opposition to be part of this protocol
Who cannot join
- Pregnant women ;
- unemancipated minors;
- Persons unable to express their consent;
- Patients with contraindications to the placement of an oesophageal Doppler probe
- Patients with suspicion of pathology or oesogastric lesion (dysphagia, diverticulum, stenosis ...)
- Patients known for stage 2 or higher oesophageal varices
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- Patients with a history of significant mediastinal irradiation, or bariatric surgery.
- Patients who have been treated in a therapeutic trial within 30 days of enrollment or who wish to participate in an ongoing study that may interfere with this study.
- Persons benefiting from legal protection measures;
- Patients unable to understand study objectives or refusing to comply with postoperative instructions
Trial locations and contacts
1 site in 1 country.
About this study
Intraoperative hemodynamic optimization decreases postoperative complications and length of stay in high risk patient. Therefore, continuous monitoring of cardiac output (Qc) is recommended to guide fluid management. Thoracic bio-reactance is a recent technique that allows cardiac output non-invasive monitoring. However, additional clinical validation studies in humans are required to better define the typologies of patients for whom this monitoring could be proposed routinely. Lung surgery is defined as an intermediate or high risk surgery regarding postoperative cardiac complications. However, surgical patients rarely benefit from continuous monitoring of cardiac output, the available methods being considered too invasive or insufficiently reliable in daily practice. Thoracic bio-reactance (Non Invasive Cardiac Output Monitor (NICOM) Starling SV) has not been studied in this subgroup of clinically relevant patients.
- Being tested
- Cardiac output monitoring with Starling SV.
- Keywords
- esophageal Doppler, thoracic surgery, pulmonary exeresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac output monitoring with Starling SV.Other
Intraoperative monitoring of cardiac output by esophageal Doppler, NICOM Starling SV and collection of values for each patient at at least 7 predefined intraoperative times.
| Study group | Role | What they receive |
|---|---|---|
| adult patients scheduled for thoracic pulmonary | Adult patients scheduled in Louis Pradel hospital operating theater (Lyon University Hospital) for elective Lung surgery (lobectomy, bilobectomy or pneumonectomy); by thoracotomy and / or thoracoscopy.
- Having stated their non opposition to be part of this protocol Receives: Other: Cardiac output monitoring with Starling SV. |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardia output measurement
The primary endpoint is the accuracy of the cardiac output value measured with the NICOM Starling SV vs. oesophageal Doppler in thoracic controlled pulmonary exeresis surgery in adults. The accuracy considered valid and reliable will be defined as the error percentage for the Cardiac Output (CO) with an acceptability (concordance) threshold of 30 %. The accuracy will be evaluated on the totality of the time points of interrest.
All data will be recorded at several time points interest (T0-T7) during surgery:
- T0 Post Induction / supine position
- T1 Lateral position closed Thorax / bipulmonary ventilation
- T2 Lateral position closed Thorax / selective unipulmonary ventilation.
- T3 Lateral position open Thorax
- T4 pleural cavity being Washed
- T5 Before Lung Recruitment Maneuver
- T6 During Positive End Expiratory Pressure (PEEP) Standardized Pulmonary Recruitment Maneuver 30 cmH20 30 seconds
- T7 End of Surgery / Awakening in lateral decubitus
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start25 Sep 2020
- Primary completion13 Mar 2021
- Study completion13 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThoracicStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
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
- NCT04251637
- Sponsor's protocol ID
- 69HCL19_0016
- Other IDs
- 2019-A01872-55
- Acronym
- NICOLE
- Status last verified
- Apr 2021
- First submitted
- 1 Aug 2019
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fellahi JL, Abraham P, Tiberghien N, Coelembier C, Maury JM, Bendjelid K. Non-invasive continuous cardiac output monitoring in thoracic cancer surgery: A comparative study between calibrated pulse contour analysis and chest bioreactance. Eur J Anaesthesiol Intensive Care. 2022 Sep 15;1(4):e006. doi: 10.1097/EA9.0000000000000006. eCollection 2022 Aug.
PubMed 39917369
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Invasive Cardiac Output Evaluation With Starling SV for Lung Elective Surgery
- ClinicalTrials.gov ID
- NCT04251637
- Acronym / sponsor ID
- NICOLE / 69HCL19_0016
- Keywords
- esophageal Doppler, thoracic surgery, pulmonary exeresis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 13 Mar 2021 (actual)
- Study completion
- 13 Mar 2021 (actual)
- First posted
- 5 Feb 2020 (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.
Intraoperative hemodynamic optimization decreases postoperative complications and length of stay in high risk patient. Therefore, continuous monitoring of cardiac output (Qc) is recommended to guide fluid management. Thoracic bio-reactance is a recent technique that allows cardiac output non-invasive monitoring. However, additional clinical validation studies in humans are required to better define the typologies of patients for whom this monitoring could be proposed routinely. Lung surgery is defined as an intermediate or high risk surgery regarding postoperative cardiac complications. However, surgical patients rarely benefit from continuous monitoring of cardiac output, the available methods being considered too invasive or insufficiently reliable in daily practice. Thoracic bio-reactance (Non Invasive Cardiac Output Monitor (NICOM) Starling SV) has not been studied in this subgroup of clinically relevant patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adult patients scheduled for thoracic pulmonary | – | Other: Cardiac output monitoring with Starling SV.Adult patients scheduled in Louis Pradel hospital operating theater (Lyon University Hospital) for elective Lung surgery (lobectomy, bilobectomy or pneumonectomy); by thoracotomy and / or thoracoscopy. - Having stated their non opposition to be part of this protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - Adult patients scheduled in Louis Pradel hospital operating theater (Lyon University Hospital) for elective Lung surgery (lobectomy, bilobectomy or pneumonectomy); by thoracotomy and / or thoracoscopy.
Key inclusion criteria (3 listed)
- Adult patients
- Scheduled in Louis Pradel hospital operating theater (Lyon University Hospital) for elective Lung surgery (lobectomy, bilobectomy or pneumonectomy); by thoracotomy and / or thoracoscopy.
- Having stated their non opposition to be part of this protocol
Key exclusion criteria (10 listed)
- Pregnant women ;
- unemancipated minors;
- Persons unable to express their consent;
- Patients with contraindications to the placement of an oesophageal Doppler probe
- Patients with suspicion of pathology or oesogastric lesion (dysphagia, diverticulum, stenosis ...)
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 |
|---|---|---|
| Cardiac output monitoring with Starling SV.Intraoperative monitoring of cardiac output by esophageal Doppler, NICOM Starling SV and collection of values for each patient at at least 7 predefined intraoperative times. | Other | adult patients scheduled for thoracic pulmonary |
Primary outcome
cardia output measurement
Time frame: Day 0
The primary endpoint is the accuracy of the cardiac output value measured with the NICOM Starling SV vs. oesophageal Doppler in thoracic controlled pulmonary exeresis surgery in adults. The accuracy considered valid and reliable will be defined as the error percentage for the Cardiac Output (CO) with an acceptability (concordance) threshold of 30 %. The accuracy will be evaluated on the totality of the time points of interrest. All data will be recorded at several time points interest (T0-T7) during surgery: * T0 Post Induction / supine position * T1 Lateral position closed Thorax / bipulmonary ventilation * T2 Lateral position closed Thorax / selective unipulmonary ventilation. * T3 Lateral position open Thorax * T4 pleural cavity being Washed * T5 Before Lung Recruitment Maneuver * T6 During Positive End Expiratory Pressure (PEEP) Standardized Pulmonary Recruitment Maneuver 30 cmH20 30 seconds * T7 End of Surgery / Awakening in lateral decubitus
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 20 Apr 2021.
- Derived from this study: PubMed 39917369Fellahi JL, Abraham P, Tiberghien N, Coelembier C, Maury JM, Bendjelid K. Non-invasive continuous cardiac output monitoring in thoracic cancer surgery: A comparative study between calibrated pulse contour analysis and chest bioreactance. Eur J Anaesthesiol Intensive Care. 2022 Sep 15;1(4):e006. doi: 10.1097/EA9.0000000000000006. eCollection 2022 Aug.
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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?
An observational study of Thoracic and Surgery, run by Hospices Civils de Lyon at 1 site 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 3 inclusion and 10 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 20 Apr 2021. 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 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?
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?
cardia output measurement (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04251637, which also lists 1 linked publication.
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 20 Apr 2021.