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Oxygen Peripheral Saturations and Lung Surgery

This study has been completed.
Sponsor:
Information provided by:
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01255033
First received: December 5, 2010
Last updated: June 23, 2011
Last verified: June 2011
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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