Oxygen Peripheral Saturations and Lung Surgery

Pulmonary Surgical Procedures Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01255033
• Other study ID #: 2010/09
• Status: Completed
• Phase: N/A
• First received: December 5, 2010
• Last updated: September 22, 2016
• Start date: November 2010
• Est. completion date: June 2011

Study information

• Verified date: September 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Scheduled lung surgery requiring one-lung ventilation

• informed consent

Exclusion Criteria:

• Pregnant woman

• Neurologic or psychiatric disorders

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pulmonary Surgical Procedures
• Recovery Period

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

References & Publications (4)

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. doi: 10.1093/bja/aen336. — View Citation

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. doi: 10.1093/bja/aep309. — View Citation

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. doi: 10.1016/j.ejvs.2009.06.011. Epub 2009 Jul 21. — View Citation

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. doi: 10.1007/s00134-009-1410-y. Epub 2009 Jan 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Desaturation during surgery and early postoperative recovery whatever the device.	Number of episodes	6 hours postoperative	No
Secondary	Chronology between devices in case of desaturation		6 hours post operative	Yes
Secondary	Quality of signal		6 hours postoperative	Yes