Effects of low pressure ventilation during spine surgery in knee-chest position
Haemodynamic and Respiratory Effects of a Low Positive End Expiratory Pressure Associated With a Fluid Challenge in Knee-chest Position- A Randomized Interventional Study
This study is testing if using a specific breathing technique during spine surgery helps patients breathe better and keeps their heart working well while they are under anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Caen Academic / other |
| Locations | 1 site (Caen) |
| Trial ID | NCT06378710 on ClinicalTrials.gov |
What this trial studies
This study investigates the hemodynamic and respiratory effects of using low positive end-expiratory pressure (PEEP) in patients undergoing spine surgery in the knee-pectoral position. The research aims to understand how this position affects cardiac output and pulmonary function during surgery. By optimizing PEEP, the study seeks to balance the respiratory benefits with potential hemodynamic drawbacks. The trial will include patients over 18 years old who require general anesthesia for surgery in this specific position.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 undergoing spine surgery that requires the knee-pectoral position under general anesthesia.
Not a fit: Patients with a BMI over 35, hemodynamic instability, or those undergoing prolonged surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve respiratory function while minimizing hemodynamic instability during spine surgeries.
How similar studies have performed: While the specific combination of low PEEP in the knee-pectoral position is novel, similar studies have shown varying results regarding the balance of hemodynamic and respiratory effects.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient \> 18 years old * Beneficiary of Social Security or CMU * Surgical operation under general anesthesia requiring a knee-pectoral position * Dated and signed informed consent Exclusion Criteria: * BMI \> 35 kg/m² * Hemodynamic instability before placing the knee in the pectoral position. * ASA class IV or V * Prolonged intervention \> 2 hours * Lack of consent * Contraindications to the use of esophageal Doppler * Concomitant third-party clinical trial that may induce a hemodynamic or respiratory change in the patient
Where this trial is running
Caen
- CAEN University Hospital — Caen, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.