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

NCT04251637 | Completed

• 2 other identifiers: 69HCL19_00162019-A01872-55
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thoracic; Surgery

Keywords

esophageal Doppler; thoracic surgery; pulmonary exeresis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Interventions

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.

adult patients scheduled for thoracic pulmonary

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Louis Pradel

Lyon, 69394, France

Location

Related Publications (1)

• 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.

  PMID: 39917369 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: February 5, 2020
• Study Start: September 25, 2020
• Primary Completion: March 13, 2021
• Study Completion: March 13, 2021
• Last Updated: April 20, 2021

Record last verified: 2021-04

Locations

FR (1)