Non Invasive Cardiac Output Evaluation With Starling SV for Lung Elective Surgery (NICOLE)
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|ClinicalTrials.gov Identifier: NCT04251637|
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
|Condition or disease||Intervention/treatment|
|Thoracic Surgery||Other: Cardiac output monitoring with Starling SV.|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|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|
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.
- 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
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
|Contact: Jean Luc Fellahi, PU,PH||04 72 11 89 33 ext +email@example.com|
|Contact: Paul ABRAHAM, PU,PH||04 72 11 89 33 ext +firstname.lastname@example.org|
|Hôpital Louis Pradel|
|Lyon, France, 69394|
|Contact: Jean Luc Fellahi, PU,PH 04 72 11 89 33 ext +33 email@example.com|
|Contact: Clément COELEMBIER, PhD 04 72 11 89 33 ext +33 firstname.lastname@example.org|
|Principal Investigator: Jean Luc Fellahi, PU,PH|