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Completed

NCT Number: NCT01255033

Oxygen Peripheral Saturations and Lung Surgery

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.

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Key information

Conditions

Pulmonary Surgical Procedures Hypoxia Pathological Conditions, Signs and Symptoms Recovery Period Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Foch

Suresnes, France, 92151

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnant woman
  • Neurologic or psychiatric disorders

Treatment and study plan

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

Primary outcomes

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

    Time frame: 6 hours postoperative

    Number of episodes

Secondary outcomes

  1. Chronology between devices in case of desaturation

    Time frame: 6 hours post operative

  2. Quality of signal

    Time frame: 6 hours postoperative

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study 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).

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 7, 2010
Registry last updated
Sep 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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