Haemodynamic and Respiratory Effects of a Low Positive End Expiratory Pressure Associated With a Fluid Challenge in Knee-chest Position

NCT06378710 | Recruiting

• 1 other identifier: 22-0219
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The genu pectoral position is a surgical position used for spine surgery. This surgical position will lead to physiological hemodynamic and respiratory changes during the procedure. The knee-pectoral position notably induces an increase in CRF and improves pulmonary ventilation/perfusion ratios. On the other hand, it has been shown that it is accompanied by a reduction in cardiac output of approximately 15% Protective perioperative ventilation including a tidal volume between 6 and 8 ml/kg of theoretical ideal weight, PEEP and alveolar recruitment maneuvers is applied in the operating room to reduce postoperative pulmonary complications. The application of high PEEP and the performance of recruitment maneuvers induce arterial hypotension through changes in intra- and transpulmonary pressures. However, investigators hypothesize that the deleterious hemodynamic effects of PEEP seem to counterbalance its beneficial respiratory effects in this particular position. The combination of the effects of the knee-pectoral position and protective ventilation could be potentiated and be the cause of the sometimes severe arterial hypotension observed in clinical practice. Since this position improves pulmonary ventilation perfusion ratios, the investigators hypothesized that a lower PEEP and the elimination of intraoperative recruitment maneuvers could be beneficial from a hemodynamic point of view without being deleterious in terms of perioperative pulmonary complications. An exploratory study was carried out at the CAEN University Hospital in 2021 under the name PEEP POSTURE (CLERS Agreement No. 2198 of February 17, 2021) on 90 patients aiming to collect hemodynamic and respiratory parameters in 3 surgical positions: supine decubitus, ventral decubitus , pectoral genu. No difference was found in the evolution of respiratory compliance. On the other hand, a significant drop in SBP, DBP and MAP in the pectoral position was shown compared to the supine group as well as greater vascular filling. The investigators therefore hypothesize that a reduction in PEEP and optimization of vascular filling could help reduce the adverse effects on blood pressure linked to the surgical position.

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

• Number of occurrences of a MAP

  Number of occurrences of a MAP \<= 65mmHg per 3 min period occurring during the period of knee pectoral position

  baseline

Study Arms (2)

control group

NO INTERVENTION

Standard PEEP (at 7 cmH2o), Vt standardized between \[6- 8\] ml/kg theoretical ideal weight. Taking NIBP every 3 minutes.

Optimized PEEP

EXPERIMENTAL

Optimized PEEP (at 2 cmH2O), filling according to VES monitoring by esophageal Doppler before reversal, Vt standardized between \[6-8\] ml/kg theoretical ideal weight. Taking NIBP every 3 minutes.

Procedure: Optimized PEEP

Interventions

Optimized PEEP PROCEDURE

Optimized PEEP

Optimized PEEP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

CAEN University Hospital

Caen, France

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 22, 2024
• Study Start: January 20, 2023
• Primary Completion: January 20, 2025
• Study Completion: January 30, 2025
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)