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

NCT ID: NCT04251637

Last Updated: 2021-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-25

Study Completion Date

2021-03-13

Brief Summary

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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.

Detailed Description

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Conditions

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Thoracic Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Cardiac output monitoring with Starling SV.

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Louis Pradel

Lyon, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 39917369 (View on PubMed)

Other Identifiers

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2019-A01872-55

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL19_0016

Identifier Type: -

Identifier Source: org_study_id

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