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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04251637
Other study ID # 69HCL19_0016
Secondary ID 2019-A01872-55
Status Completed
Phase
First received
Last updated
Start date September 25, 2020
Est. completion date March 13, 2021

Study information

Verified date April 2021
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date March 13, 2021
Est. primary completion date March 13, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
France Hôpital Louis Pradel Lyon

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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