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

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.

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Key information

Conditions

Thoracic Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Louis Pradel

Lyon, 69394, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: NICOLE

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Feb 5, 2020
Registry last updated: Apr 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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