Oxygen Peripheral Saturations and Lung Surgery - Full Text View

Purpose

The purpose of this study is to compare the ability of two peripheral and non invasive devices to detect hypoxic events during one-lung ventilation and during the early postoperative period. One device measures regional cerebral oxygenation and the other muscular oxygenation. These two devices are compared to non invasive arterial saturation (SpO2), which is the gold standard.

Condition	Intervention
Pulmonary Surgical Procedures Recovery Period	Device: Monitoring of tissular oxygenation

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
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).

Further study details as provided by Hopital Foch:

Primary Outcome Measures:

Desaturation during surgery and early postoperative recovery whatever the device. [ Time Frame: 6 hours postoperative ] [ Designated as safety issue: No ]
Number of episodes

Secondary Outcome Measures:

Chronology between devices in case of desaturation [ Time Frame: 6 hours post operative ] [ Designated as safety issue: Yes ]
Quality of signal [ Time Frame: 6 hours postoperative ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	November 2010
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients submitted for scheduled lung surgery requiring one-lung ventilation

Criteria

Inclusion Criteria:

Scheduled lung surgery requiring one-lung ventilation
informed consent

Exclusion Criteria:

Pregnant woman
Neurologic or psychiatric disorders

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01255033

Locations

France
Hôpital Foch
Suresnes, France, 92151

Sponsors and Collaborators

Hopital Foch

Investigators

Study Chair:

Marc Fischler

Hôpital Foch

More Information

Publications:

Kazan R, Bracco D, Hemmerling TM. Reduced cerebral oxygen saturation measured by absolute cerebral oximetry during thoracic surgery correlates with postoperative complications. Br J Anaesth. 2009 Dec;103(6):811-6.

Hemmerling TM, Kazan R, Bracco D. Inter-hemispheric cerebral oxygen saturation differences during thoracic surgery in lateral head positioning. Br J Anaesth. 2009 Jan;102(1):141-2. No abstract available.

Manfredini F, Malagoni AM, Felisatti M, Mandini S, Mascoli F, Manfredini R, Basaglia N, Zamboni P. A dynamic objective evaluation of peripheral arterial disease by near-infrared spectroscopy. Eur J Vasc Endovasc Surg. 2009 Oct;38(4):441-8. Epub 2009 Jul 21.

Mesquida J, Masip J, Gili G, Artigas A, Baigorri F. Thenar oxygen saturation measured by near infrared spectroscopy as a noninvasive predictor of low central venous oxygen saturation in septic patients. Intensive Care Med. 2009 Jun;35(6):1106-9. Epub 2009 Jan 29.

Responsible Party:	Dr Marc Fischler, Hôpital Foch
ClinicalTrials.gov Identifier:	NCT01255033 History of Changes
Other Study ID Numbers:	2010/09
Study First Received:	December 5, 2010
Last Updated:	June 23, 2011
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hopital Foch:

perioperative surgery
regional oxygenation
hypoxemia
brain hypoxemia
spectroscopy, near-infrared

ClinicalTrials.gov processed this record on May 19, 2013