OsteotomiesMRA-RACHISNCT02285946
Comparison of Supine to Prone Position During Major Spinal Surgery
An observational study of Osteotomies, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
During mechanical ventilation, the alveolar recruitment maneuver (ARM) is to apply a positive end-expiratory pressure (PEEP) (generally 30 cm H2O) for a period of at least 30 seconds. The realization of MRA is one of three main elements of mechanical ventilation called "protective". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteotomies
- What is being tested?
- major spine surgery
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2014to 1 Sep 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient operated major spine surgery, including: * The transpedicular osteotomies * Tumor spinal surgery (sarcoma, osteosarcoma) or metastatic * Degenerative spinal surgery on multiple vertebral levels and degraded land * Surgery of scoliosis * Recovery of spinal surgery on several levels * Sepsis spinal presumed origin
Who may be able to join
- Adult patient
- Patient operated major spine surgery, including:
- The transpedicular osteotomies
- Tumor spinal surgery (sarcoma, osteosarcoma) or metastatic
- Degenerative spinal surgery on multiple vertebral levels and degraded land
- Surgery of scoliosis
Who cannot join
- Inability to give informed patient information (eg difficulty of understanding)
- Patient under guardianship - Patient pregnant or during lactation - Detainees or under judicial protection.
- contraindications to MRA: emphysema, pneumothorax, major hypovolemia, hemodynamic instability defined as systolic blood pressure below 90 mmHg or tachycardia greater than 110 bpm.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alveolar Recruitment Maneuvers: Comparison of Supine to Prone Position During Major Spinal Surgery
During mechanical ventilation, the alveolar recruitment maneuver (ARM) is to apply a positive end-expiratory pressure (PEEP) (generally 30 cm H2O) for a period of at least 30 seconds. The realization of MRA is one of three main elements of mechanical ventilation called "protective". This ventilatory strategy, originally described for the ventilation of acute respiratory distress syndrome (ARDS), and pulmonary and during abdominal surgery is based on a decrease tidal volumes, optimization of PEEP and the realization of MRA. Protective ventilation limit the occurrence of atelectasis, the surdistentions and, ultimately, significantly decreases postoperative complications.
The MRA is currently recommended in the "major" surgery. Most spine surgery (eg transpedicular fixation) used in this definition, the MRA are indicated and now commonly used. This type of surgery requires further positioning the patient in the prone position (DV). The DV modifies the compliance of the chest respiratory characteristics and changes (increase in insufflation pressure) and hemodynamic (decreased venous return) of the patient.
Read more
Respiratory and haemodynamic effects of MRA made VIS at major spine surgery are not known. The aim of this observational study, non-interventional, is to compare the hemodynamic and respiratory effects of MRA performed in DV to those of MRA performed in the prone position (DD).
The investigators hypothesis is that the respiratory and hemodynamic consequences of MRA performed in DV is different from those conducted in DD. A better understanding of hemodynamic and respiratory characteristics of MRA performed in DV would provide a more tailored to this type of surgery respiratory optimization strategy and reduce respiratory complications of this surgery.
- Conditions
- Osteotomies
- Being tested
- major spine surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
major spine surgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
The hemodynamic and respiratory data are collected before, during and after the completion of 3 ARM (alveolar recruitment maneuver):
Measured: T1: ARM (in a supine position) (before setting prone position); T2: ARM (prone position) ; T3: ARM at acute respiratory distress syndrome [ARDS] (end of intervention, after supine position); (* At the end of ARM, only hemodynamic data are collected)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startNov 2014
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteotomiesStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- COLLANGE Olivier, MD, Principal investigator, Strasbourg University Hospital, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02285946
- Sponsor's protocol ID
- 6032
- Acronym
- MRA-RACHIS
- Status last verified
- Sep 2025
- First submitted
- 2 Oct 2014
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alveolar Recruitment Maneuvers: Comparison of Supine to Prone Position During Major Spinal Surgery
- ClinicalTrials.gov ID
- NCT02285946
- Acronym / sponsor ID
- MRA-RACHIS / 6032
- Conditions
- Osteotomies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 7 Nov 2014 (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.
During mechanical ventilation, the alveolar recruitment maneuver (ARM) is to apply a positive end-expiratory pressure (PEEP) (generally 30 cm H2O) for a period of at least 30 seconds. The realization of MRA is one of three main elements of mechanical ventilation called "protective". This ventilatory strategy, originally described for the ventilation of acute respiratory distress syndrome (ARDS), and pulmonary and during abdominal surgery is based on a decrease tidal volumes, optimization of PEEP and the realization of MRA. Protective ventilation limit the occurrence of atelectasis, the surdistentions and, ultimately, significantly decreases postoperative complications.
The MRA is currently recommended in the "major" surgery. Most spine surgery (eg transpedicular fixation) used in this definition, the MRA are indicated and now commonly used. This type of surgery requires further positioning the patient in the prone position (DV). The DV modifies the compliance of the chest respiratory characteristics and changes (increase in insufflation pressure) and hemodynamic (decreased venous return) of the patient.
Respiratory and haemodynamic effects of MRA made VIS at major spine surgery are not known. The aim of this observational study, non-interventional, is to compare the hemodynamic and respiratory effects of MRA performed in DV to those of MRA performed in the prone position (DD).
The investigators hypothesis is that the respiratory and hemodynamic consequences of MRA performed in DV is different from those conducted in DD. A better understanding of hemodynamic and respiratory characteristics of MRA performed in DV would provide a more tailored to this type of surgery respiratory optimization strategy and reduce respiratory complications of this surgery.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient operated major spine surgery, including: * The transpedicular osteotomies * Tumor spinal surgery (sarcoma, osteosarcoma) or metastatic * Degenerative spinal surgery on multiple vertebral levels and degraded land * Surgery of scoliosis * Recovery of spinal surgery on several levels * Sepsis spinal presumed origin
Key inclusion criteria (6 listed)
- Adult patient
- The transpedicular osteotomies
- Tumor spinal surgery (sarcoma, osteosarcoma) or metastatic
- Degenerative spinal surgery on multiple vertebral levels and degraded land
- Surgery of scoliosis
Key exclusion criteria (3 listed)
- Inability to give informed patient information (eg difficulty of understanding)
- Patient under guardianship - Patient pregnant or during lactation - Detainees or under judicial protection.
- contraindications to MRA: emphysema, pneumothorax, major hypovolemia, hemodynamic instability defined as systolic blood pressure below 90 mmHg or tachycardia greater than 110 bpm.
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 |
|---|---|---|
| major spine surgery | Procedure or surgery | – |
Primary outcome
The hemodynamic and respiratory data are collected before, during and after the completion of 3 ARM (alveolar recruitment maneuver):
Time frame: T1: ARM (in a supine position) (before setting prone position); T2: ARM (prone position) ; T3: ARM at acute respiratory distress syndrome [ARDS] (end of intervention, after supine position); (* At the end of ARM, only hemodynamic data are collected)
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 5 Sep 2025.
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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.
COLLANGE Olivier, MD principal investigator
Strasbourg University Hospital, France
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 Osteotomies, run by University Hospital, Strasbourg, France 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 6 inclusion and 3 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 5 Sep 2025. 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?
The hemodynamic and respiratory data are collected before, during and after the completion of 3 ARM (alveolar recruitment maneuver): (time frame: T1: ARM (in a supine position) (before setting prone position); T2: ARM (prone position) ; T3: ARM at acute respiratory distress syndrome [ARDS] (end of intervention, after supine position); (* At the end of ARM, only hemodynamic data are collected)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2025.