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Completed

NCT Number: NCT02285946

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service D'Anesthesiologie - Nhc

Strasbourg, 67091, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

major spine surgery

Procedure

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)

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Alveolar Recruitment Maneuvers: Comparison of Supine to Prone Position During Major Spinal Surgery

Acronym: MRA-RACHIS

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 7, 2014
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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