Oxygen Peripheral Saturations and Lung Surgery
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|ClinicalTrials.gov Identifier: NCT01255033|
Recruitment Status : Completed
First Posted : December 7, 2010
Last Update Posted : September 23, 2016
|Condition or disease||Intervention/treatment|
|Pulmonary Surgical Procedures Recovery Period||Device: Monitoring of tissular oxygenation|
Lung surgery is often complicated by hypoxic evants :
- during one-lung ventilation which leads to changes about ratio in ventilated and perfused lung areas. This blood flow redistribution promotes shunt with a decreased arterial oxygenation and possible hypoxemia.
- during the postoperative period.
Common measure of arterial saturation through SpO2 may miss a great number of hypoxic events with regional impact because a significant decrease in SpO2 occurs for an arterial pressure in oxygen below 60 mmHg. Currently, cerebral and somatic saturation can be monitored non-invasively and continuously via optical sensors applied to the right and left forehead and to the thenar eminence. These devices may help clinicians in the detection of such hypoxemic events.
|Study Type :||Observational|
|Actual Enrollment :||47 participants|
|Official Title:||Evaluation of the Continuous Measurement of Tissular (StO2) and Cerebral (ScO2) Oxygenation During Lung Surgery and During the 6 First Postoperative Hours (Prospective Monocentric Study).|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
Pulmonary surgical patients
Patients submitted for scheduled lung surgery requiring one-lung ventilation
Device: Monitoring of tissular oxygenation
Equanox: cerebral oxygenation by spectroscopy, near-infrared through forehead and noninvasive devices
Inspectra: tissular oxygenation by spectroscopy, near-infrared through thenar and noninvasive device
- Desaturation during surgery and early postoperative recovery whatever the device. [ Time Frame: 6 hours postoperative ]Number of episodes
- Chronology between devices in case of desaturation [ Time Frame: 6 hours post operative ]
- Quality of signal [ Time Frame: 6 hours postoperative ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01255033
|Suresnes, France, 92151|
|Study Chair:||Marc Fischler||Hôpital Foch|