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Non Invasive Cardiac Output Evaluation With Starling SV for Lung Elective Surgery (NICOLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04251637
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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. 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.

Condition or disease Intervention/treatment
Thoracic Surgery Other: Cardiac output monitoring with Starling SV.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non Invasive Cardiac Output Evaluation With Starling SV for Lung Elective Surgery
Estimated Study Start Date : March 1, 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021

Group/Cohort Intervention/treatment
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

Other: 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.




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251637


Contacts
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Contact: Jean Luc Fellahi, PU,PH 04 72 11 89 33 ext +33 jean-luc.fellahi@chu-lyon.fr
Contact: Paul ABRAHAM, PU,PH 04 72 11 89 33 ext +33 paul.abraham@chu-lyon.fr

Locations
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France
Hôpital Louis Pradel
Lyon, France, 69394
Contact: Jean Luc Fellahi, PU,PH    04 72 11 89 33 ext +33    jean-luc.fellahi@chu-lyon.fr   
Contact: Clément COELEMBIER, PhD    04 72 11 89 33 ext +33    clement.coelembier@chu-lyon.fr   
Principal Investigator: Jean Luc Fellahi, PU,PH         
Sponsors and Collaborators
Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04251637    
Other Study ID Numbers: 69HCL19_0016
2019-A01872-55 ( Other Identifier: ID-RCB )
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
esophageal Doppler
thoracic surgery
pulmonary exeresis