Assessment of Oxygen Delivery as an Early Predictor of Postoperative Pulmonary Complications During One-lung Pulmonary Ventilation in Thoracic Surgery. A Pilot Study

NCT05154617 | Unknown

• 1 other identifier: 21-5094
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a simple descriptive pilot study where 60 patients undergoing One-lung ventilation (OLV) for \> 120 minutes during esophagectomy will be enrolled to see if the Flo Trac® system can identify hypoxemia earlier than the standard of care monitoring.

Conditions

Postoperative Pulmonary Complications

Keywords

Thoracic surgery; Oxygen delivery; One-lung pulmonary ventilation

Outcome Measures

Primary Outcomes (1)

• The primary outcome will be the occurrence of any POPCs within 30 days of surgery.

  30 days from the day of surgery

Study Arms (1)

Standard surgical monitoring, along with the Flo Trac® system monitoring.

OTHER

Diagnostic Test: Standard surgical monitoring, along with the Flo Trac® system monitoring.

Interventions

Standard surgical monitoring, along with the Flo Trac® system monitoring. DIAGNOSTIC_TEST

Under standard thoracic anesthesia protocol, extra monitoring will be done by FloTrac® System using a minimally invasive sensor in combination with an advanced monitoring device to derive cardiac output (CO) and cardiac index (CI) parameters through arterial pulse pressure waveform analysis. Intraoperative blood gases collection will be at different intraoperative times. From this data, calculations will be performed to obtain DO2, DO2i, O2ER, and O2ERi.

Standard surgical monitoring, along with the Flo Trac® system monitoring.

Eligibility Criteria

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

You may qualify if:

• Adults ≥ 18 years
• Esophagectomy surgery requiring one-lung ventilation for \> 120 minutes

You may not qualify if:

• Severe heart disease (LVEF (Left ventricle ejection fraction) \<50%) and/or Heart failure with CI (cardiac index) \<2.5 l/min/m2 or need of vasopressors and/or ionotropic support
• Genetic alterations of hemoglobin
• Pregnant patients
• History of severe restrictive lung disease (such as pulmonary fibrosis with minimal FEV1 of \<75% or COPD/emphysema with minimal FEV1 of \<50%) which may affect inflation/deflation times
• Trauma patients requiring VATS/thoracotomy
• Patient with recent mechanical ventilation support (2 weeks)

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Officials

• Jacobo Moreno Garijo, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacobo Moreno Garijo, MD

CONTACT

(416) 340-4800; Jacobo.Moreno@uhn.ca

Jo Carroll

CONTACT

(416) 340-4800; jo.carroll@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: December 13, 2021
• Study Start: January 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2023
• Last Updated: December 13, 2021

Record last verified: 2021-08