Oxygen Peripheral Saturations and Lung Surgery

NCT ID: NCT01255033

Last Updated: 2016-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pulmonary Surgical Procedures Recovery Period

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pulmonary surgical patients

Patients submitted for scheduled lung surgery requiring one-lung ventilation

Monitoring of tissular oxygenation

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnant woman
* Neurologic or psychiatric disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc Fischler

Role: STUDY_CHAIR

Hôpital Foch

Locations

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Hôpital Foch

Suresnes, France, France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 19625198 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19183952 (View on PubMed)

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.

Reference Type RESULT
PMID: 19918024 (View on PubMed)

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.

Reference Type RESULT
PMID: 19059925 (View on PubMed)

Other Identifiers

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2010/09

Identifier Type: -

Identifier Source: org_study_id

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