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CompletedNCT02285946MRA-RACHISUpdated Sep 5, 2025

Comparison of Supine to Prone Position During Major Spinal Surgery

An observational study in Osteotomies, sponsored by University Hospital, Strasbourg, France. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-05.

Sponsored by University Hospital, Strasbourg, France · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study 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". 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.

02

Conditions studied

  • Osteotomies
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In context

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 966 studies on the registry; 342 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

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

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.
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No

Interventions

  • Proceduremajor spine surgery
06

What researchers measure

Primary outcomes

  1. 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)

07

Study locations

1 site
  • Service D'Anesthesiologie - Nhc
    Strasbourg, 67091, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02285946
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Nov 7, 2014
Start date
Nov 2014
Primary completion
Sep 1, 2017
Completion
Sep 1, 2017
Last update
Sep 5, 2025

Study contacts

COLLANGE Olivier, MD
principal investigator · Strasbourg University Hospital, France

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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