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

Surgery Clinical Trial

— OPTIPEP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06378710
• Other study ID #: 22-0219
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2023
• Est. completion date: January 30, 2025

Study information

• Verified date: April 2024
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: January 30, 2025
• Est. primary completion date: January 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgery

Intervention

Procedure:
• Optimized PEEP
Optimized PEEP

Locations

Country	Name	City	State
France	CAEN University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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