Pulmonary Surgical ProceduresNCT01255033
Oxygen Peripheral Saturations and Lung Surgery
An observational study of Pulmonary Surgical Procedures and Recovery Period, run by Hopital Foch at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pulmonary Surgical Procedures, Recovery Period
- What is being tested?
- Monitoring of tissular oxygenation
- Type of treatment
- Medical device
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2010to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients submitted for scheduled lung surgery requiring one-lung ventilation
Who may be able to join
- Scheduled lung surgery requiring one-lung ventilation
- informed consent
Who cannot join
- Pregnant woman
- Neurologic or psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
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).
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.
Read the 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.
- Conditions
- Pulmonary Surgical Procedures, Recovery Period
- Being tested
- Monitoring of tissular oxygenation
- Keywords
- perioperative surgery, regional oxygenation, hypoxemia, brain hypoxemia, spectroscopy, near-infrared
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring of tissular oxygenationDevice
Equanox: cerebral oxygenation by spectroscopy, near-infrared through forehead and noninvasive devices
Inspectra: tissular oxygenation by spectroscopy, near-infrared through thenar and noninvasive device
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary surgical patients | Patients submitted for scheduled lung surgery requiring one-lung ventilation Receives: Device: Monitoring of tissular oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Desaturation during surgery and early postoperative recovery whatever the device.
Number of episodes
Measured: 6 hours postoperative
Secondary outcomes (2)
Chronology between devices in case of desaturation
Measured: 6 hours post operative
Quality of signal
Measured: 6 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Surgical ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Fischler, Study chair, Hôpital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255033
- Sponsor's protocol ID
- 2010/09
- Status last verified
- Sep 2016
- First submitted
- 5 Dec 2010
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19625198Mesquida 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.
PubMed 19183952Kazan 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.
PubMed 19918024Hemmerling 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.
PubMed 19059925
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT01255033
- Acronym / sponsor ID
- 2010/09
- Conditions
- Pulmonary Surgical Procedures, Recovery Period
- Keywords
- perioperative surgery, regional oxygenation, hypoxemia, brain hypoxemia, spectroscopy, near-infrared
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 7 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary surgical patients | – | Device: Monitoring of tissular oxygenationPatients submitted for scheduled lung surgery requiring one-lung ventilation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients submitted for scheduled lung surgery requiring one-lung ventilation
Key inclusion criteria (2 listed)
- Scheduled lung surgery requiring one-lung ventilation
- informed consent
Key exclusion criteria (2 listed)
- Pregnant woman
- Neurologic or psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring of tissular oxygenationEquanox: cerebral oxygenation by spectroscopy, near-infrared through forehead and noninvasive devices Inspectra: tissular oxygenation by spectroscopy, near-infrared through thenar and noninvasive device | Device | Pulmonary surgical patients |
Primary outcome
Desaturation during surgery and early postoperative recovery whatever the device.
Time frame: 6 hours postoperative
Number of episodes
2 secondary outcomes
Chronology between devices in case of desaturation
Time frame: 6 hours post operative
Quality of signal
Time frame: 6 hours postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
- Background: PubMed 19625198Manfredini 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.
- Background: PubMed 19183952Mesquida 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.
- Results publication: PubMed 19918024Kazan 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.
- Results publication: PubMed 19059925Hemmerling 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Fischler study chair
Hôpital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Surgical Procedures and Recovery Period, run by Hopital Foch at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Desaturation during surgery and early postoperative recovery whatever the device. (time frame: 6 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01255033, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2016.