- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02285946
Comparison of Supine to Prone Position During Major Spinal Surgery (MRA-RACHIS)
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.
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 Overview
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: COLLANGE Olivier, MD
- Phone Number: 33369551551
- Email: olivier.collange@chru-strasbourg.fr
Study Contact Backup
- Name: Kieffer Vianney, MD
- Phone Number: 33369551551
- Email: vianney.kieffer@chru-strasbourg.fr
Study Locations
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Strasbourg, France, 67091
- Not yet recruiting
- Service d'Anesthesiologie - NHC
-
Contact:
- Collonge Olivier, MD
- Phone Number: 33369551551
- Email: olivier.collange@chru-strasbourg.fr
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Strasbourg, France, 67091
- Recruiting
- Service d'Anesthesiologie - NHC
-
Contact:
- Olivier COLLONGE, MD
- Phone Number: 33 3 69 55 51 51
- Email: olivier.collange@chru-strasbourg.fr
-
Contact:
- Vianney KIEFFER, MD
- Phone Number: 33 3 69 55 51 51
- Email: vianney.kieffer@chru-strasbourg.fr
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Principal Investigator:
- Olivier COLLONGE, MD
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Sub-Investigator:
- Vianney KIEFFER, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
Description
Inclusion Criteria:
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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
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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)
|
Collaborators and Investigators
Investigators
- Principal Investigator: COLLANGE Olivier, MD, Strasbourg University Hospital, France
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 6032 (CTEP)
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