Major Thoracic and Abdominal SurgeryFreeO2PostOpNCT02546830
Automatic Oxygen Administration After Major Abdominal and Thoracic Surgery
A study testing FreeO2 v2.2 active and FreeO2 v2.2 with manual oxygenation in people with Major Thoracic and Abdominal Surgery, run by University Hospital, Brest at 5 sites in 2 countries.
Trial summary
The aim of the study is to assess the use feasibility of the FreeO2 system so as to deliver automatically oxygen in the post anesthesia care unit in a patient population admitted for major abdominal and thoracic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Thoracic and Abdominal Surgery
- What is being tested?
- FreeO2 v2.2 active and FreeO2 v2.2 with manual oxygenation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jan 2016to Oct 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Preoperative anesthetic visit for major thoracic or abdominal surgery ( ARISCAT risk score ≥ 26) with general anesthesia
- Patient consent
- Randomization Criteria:
- Admission in post-anesthesia care unit after major thoracic or abdominal surgery
- Randomization and device establishment within a time less than one hour after the endotracheal intubation
- Availability of the prototype FreeO2
Show all 15Show fewer
- Absence of criteria of gravity justifying immediately a different technique of ventilatory support:
- Disturbance of consciousness with a Glasgow Coma Score ≤ 12
- Serious ventricular rhythm disorders
- Hemodynamic instability (SBP <80mmHg or recourse to vasopressors)
- Cardiac or respiratory arrest
- pH < 7.35 and PaCO2 > 55 mm Hg
- Necessity of an oxygen flow less than 15 L / min to maintain a SpO2 higher than 92%.
- Absence of necessity of a urgent surgery
- Oxygen saturation measured by Spo2 sensor
Who cannot join
- BMI ≥ 35 kg/m2
- Obstructive sleep Apnea (with or without Mechanical therapy)
- Emergency Surgery for life-threatening
- Age <18 years
- Pregnant women, lactating
- perturbed or non-cooperative patient
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
France4 sites
Brest, University Hospital
Brest
CHU Clermont-Ferrand
Clermont-Ferrand, 63000
CHU Montpellier
Montpellier, 34295
CHU Poitiers
Poitiers, 86021
About this study
Official title: Automatic Oxygen Administration in Early and Late Postoperative Hypoxaemia Prevention After Major Abdominal and Thoracic Surgery
The aim of the study is to assess the use feasibility of the FreeO2 system so as to deliver automatically oxygen in the post anesthesia care unit in a patient population admitted for major abdominal and thoracic surgery.
The investigators' hypothesis is that FreeO2 system will provide a better control of the oxygen saturation and reduce postoperative hypoxaemia.
- Conditions
- Major Thoracic and Abdominal Surgery
- Being tested
- FreeO2 v2.2 active, FreeO2 v2.2 with manual oxygenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FreeO2 v2.2 activeDevice
- Automatic adjustment of oxygen through the "Free O2" device.
- "FreeO2" device in mode medical data collecting(SpO2,EtCO2...).
FreeO2 v2.2 with manual oxygenationDevice
- Manual adjustment of oxygen without the assistance of the "FreeO2" device.
- Only "FreeO2" device in mode medical data collecting(SpO2,EtCO2...).
| Study group | Role | What they receive |
|---|---|---|
| FreeO2 v2.2 active | Experimental | Automatic Oxygen Administration Receives: Device: FreeO2 v2.2 active |
| FreeO2 v2.2 with manual oxygenation | Active comparator | Manual Oxygen Administration Receives: Device: FreeO2 v2.2 with manual oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time spent in the target zone of oxygen saturation
The target zone of oxygen saturation is : SpO2 = 88-92% for COPD patient and 92-96% for non COPD
Measured: 3 days
Secondary outcomes (9)
nursing workload
nursing workload assessed by the number of manual Oxygen flow adjustments and airway management procedures
Measured: 3 days
Time spent in a area of severe desaturation (SpO2 <85%)
Time spent in a area of severe desaturation (SpO2 <85%) evaluated by freeO2 device
Measured: 3 days
Time spent in a hyperoxia area (SpO2> 98%).
Time spent in a hyperoxia area (SpO2> 98%) evaluated by freeO2 device
Measured: 3 days
Maintaining EtCO2 in a selected area
Maintaining EtCO2 in a selected area evaluated by freeO2 device
Measured: 3 days
Oxygen consumption measured at the end of administration
Oxygen consumption measured at the end of administration
Measured: 3 days
Duration of oxygen administration during hospitalization
Duration of oxygen administration during hospitalization
Measured: 3 days
Number of complications related to the administration of oxygen
Number of complications related to the administration of oxygen
Measured: 28 days max
Frequency of use of ventilation (invasive or noninvasive )
Frequency of use of ventilation (invasive or noninvasive )
Measured: 28 days max
Duration of hospitalization
Duration of hospitalization
Measured: 28 days max
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startJan 2016
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Thoracic and Abdominal SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erwan L'HER, Principal investigator, University Hospital, Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02546830
- Sponsor's protocol ID
- RB14-060
- Other IDs
- CHRU de Brest
- Acronym
- FreeO2PostOp
- Status last verified
- Jan 2019
- First submitted
- 20 Aug 2015
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
L'Her E, Jaber S, Verzilli D, Jacob C, Huiban B, Futier E, Kerforne T, Pateau V, Bouchard PA, Consigny M, Lellouche F. Automated closed-loop versus standard manual oxygen administration after major abdominal or thoracic surgery: an international multicentre randomised controlled study. Eur Respir J. 2021 Jan 5;57(1):2000182. doi: 10.1183/13993003.00182-2020. Print 2021 Jan.
PubMed 32855218L'her E, Jaber S, Verzilli D, Jacob C, Huiban B, Futier E, Kerforne T, Pateau V, Bouchard PA, Gouillou M, Nowak E, Lellouche F. Automated oxygen administration versus conventional oxygen therapy after major abdominal or thoracic surgery: study protocol for an international multicentre randomised controlled study. BMJ Open. 2019 Jan 17;9(1):e023833. doi: 10.1136/bmjopen-2018-023833.
PubMed 30782716
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automatic Oxygen Administration in Early and Late Postoperative Hypoxaemia Prevention After Major Abdominal and Thoracic Surgery
- ClinicalTrials.gov ID
- NCT02546830
- Acronym / sponsor ID
- FreeO2PostOp / RB14-060
- Conditions
- Major Thoracic and Abdominal Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 11 Sep 2015 (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 aim of the study is to assess the use feasibility of the FreeO2 system so as to deliver automatically oxygen in the post anesthesia care unit in a patient population admitted for major abdominal and thoracic surgery.
The investigators' hypothesis is that FreeO2 system will provide a better control of the oxygen saturation and reduce postoperative hypoxaemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FreeO2 v2.2 active | Experimental | Device: FreeO2 v2.2 activeAutomatic Oxygen Administration |
| FreeO2 v2.2 with manual oxygenation | Active comparator | Device: FreeO2 v2.2 with manual oxygenationManual Oxygen Administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Preoperative anesthetic visit for major thoracic or abdominal surgery ( ARISCAT risk score ≥ 26) with general anesthesia
- Patient consent
- Admission in post-anesthesia care unit after major thoracic or abdominal surgery
- Randomization and device establishment within a time less than one hour after the endotracheal intubation
- Availability of the prototype FreeO2
Key exclusion criteria (6 listed)
- BMI ≥ 35 kg/m2
- Obstructive sleep Apnea (with or without Mechanical therapy)
- Emergency Surgery for life-threatening
- Age <18 years
- Pregnant women, lactating
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 |
|---|---|---|
| FreeO2 v2.2 active* Automatic adjustment of oxygen through the "Free O2" device. * "FreeO2" device in mode medical data collecting(SpO2,EtCO2...). | Device | FreeO2 v2.2 active |
| FreeO2 v2.2 with manual oxygenation* Manual adjustment of oxygen without the assistance of the "FreeO2" device. * Only "FreeO2" device in mode medical data collecting(SpO2,EtCO2...). | Device | FreeO2 v2.2 with manual oxygenation |
Primary outcome
Percentage of time spent in the target zone of oxygen saturation
Time frame: 3 days
The target zone of oxygen saturation is : SpO2 = 88-92% for COPD patient and 92-96% for non COPD
9 secondary outcomes
nursing workload
Time frame: 3 days
Time spent in a area of severe desaturation (SpO2 <85%)
Time frame: 3 days
Time spent in a hyperoxia area (SpO2> 98%).
Time frame: 3 days
Maintaining EtCO2 in a selected area
Time frame: 3 days
Oxygen consumption measured at the end of administration
Time frame: 3 days
Duration of oxygen administration during hospitalization
Time frame: 3 days
Number of complications related to the administration of oxygen
Time frame: 28 days max
Frequency of use of ventilation (invasive or noninvasive )
Time frame: 28 days max
Duration of hospitalization
Time frame: 28 days max
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 16 Jan 2019.
- Derived from this study: PubMed 32855218L'Her E, Jaber S, Verzilli D, Jacob C, Huiban B, Futier E, Kerforne T, Pateau V, Bouchard PA, Consigny M, Lellouche F. Automated closed-loop versus standard manual oxygen administration after major abdominal or thoracic surgery: an international multicentre randomised controlled study. Eur Respir J. 2021 Jan 5;57(1):2000182. doi: 10.1183/13993003.00182-2020. Print 2021 Jan.
- Derived from this study: PubMed 30782716L'her E, Jaber S, Verzilli D, Jacob C, Huiban B, Futier E, Kerforne T, Pateau V, Bouchard PA, Gouillou M, Nowak E, Lellouche F. Automated oxygen administration versus conventional oxygen therapy after major abdominal or thoracic surgery: study protocol for an international multicentre randomised controlled study. BMJ Open. 2019 Jan 17;9(1):e023833. doi: 10.1136/bmjopen-2018-023833.
- Individual participant dataSharing planned: No
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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.
Erwan L'HER principal investigator
University Hospital, Brest
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FreeO2 v2.2 active and FreeO2 v2.2 with manual oxygenation in people with Major Thoracic and Abdominal Surgery, run by University Hospital, Brest at 5 sites in 2 countries.
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 15 inclusion and 6 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 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Canada. 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?
Percentage of time spent in the target zone of oxygen saturation (time frame: 3 days). 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 NCT02546830, which also lists 2 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 16 Jan 2019.