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

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 Overview

• Status: Completed
• Conditions: Surgery; Thoracic
• Intervention / Treatment: Other: Cardiac output monitoring with Starling SV.

• Study Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69394
    • Hôpital Louis Pradel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 0

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2020
• Primary Completion (Actual): March 13, 2021
• Study Completion (Actual): March 13, 2021

Study Registration Dates

• First Submitted: August 1, 2019
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): April 20, 2021
• Last Update Submitted That Met QC Criteria: April 19, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: thoracic surgery; esophageal Doppler; pulmonary exeresis
• Other Study ID Numbers: 69HCL19_0016; 2019-A01872-55 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No