Oxygen Peripheral Saturations and Lung Surgery

NCT01255033 | Completed

• 1 other identifier: 2010/09
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Surgical Procedures; Recovery Period

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Desaturation during surgery and early postoperative recovery whatever the device.

  Number of episodes

  6 hours postoperative

Secondary Outcomes (2)

• Chronology between devices in case of desaturation

  6 hours post operative

• Quality of signal

  6 hours postoperative

Study Arms (1)

Pulmonary surgical patients

Patients submitted for scheduled lung surgery requiring one-lung ventilation

Device: Monitoring of tissular oxygenation

Interventions

Monitoring of tissular oxygenation DEVICE

Equanox: cerebral oxygenation by spectroscopy, near-infrared through forehead and noninvasive devices Inspectra: tissular oxygenation by spectroscopy, near-infrared through thenar and noninvasive device

Pulmonary surgical patients

Eligibility Criteria

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

Study Population

Patients submitted for scheduled lung surgery requiring one-lung ventilation

You may qualify if:

• Scheduled lung surgery requiring one-lung ventilation
• informed consent

You may not qualify if:

• Pregnant woman
• Neurologic or psychiatric disorders

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Hôpital Foch

Suresnes, France, 92151, France

Location

Related Publications (4)

• 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.

  PMID: 19625198 BACKGROUND

• 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.

  PMID: 19183952 BACKGROUND

• 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.

  PMID: 19918024 RESULT

• 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. No abstract available.

  PMID: 19059925 RESULT

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc Fischler

  Hôpital Foch

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: December 5, 2010
• First Posted: December 7, 2010
• Study Start: November 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: September 23, 2016

Record last verified: 2016-09

Locations

FR (1)