Optimal Positive End-expiratory Pressure (PEEP) in Prone Position During Spine Surgery

Completed

• Conditions: Surgery; Anesthesia

• Registration Number: NCT04024410
• Lead Sponsor: Parc de Salut Mar

Brief Summary

Background:

There is a lack of studies regarding Optimal (best) positive end-expiratory pressure (PEEP) in prone position during surgery, and its relation with optimal PEEP in supine position.

Hypothesis:

In patients undergoing scheduled spinal surgery, optimal PEEP in the prone position is lower than optimal PEEP in the supine position.

Aims:

To assess the difference optimal PEEP in supine vs. prone positions in patients undergoing spine surgery.

To evaluate the changes in optimal PEEP in prone position throughout the surgical procedure.

Methods:

Observational study, one center. Main variable: optimal PEEP. Secondary variables: PaO2, pCO2 and dynamic compliance (Crd) in prone and supine position.

Detailed Description

Recruitment: Patients scheduled for spine surgery were Main outcome: Optimal PEEP determined after a pulmonary recruitment manoeuvre in supine and in prone position and every hour during the surgery in prone position.

Secondary outcomes: Pulmonary compliance, blood gas analysis and hemodynamic parameters

Study Timeline

• Status Verified: 2019-06
• Study Start: 2019-06-03
• Study First Submitted: 2019-06-27
• Study First Submitted QC: 2019-07-16
• Study First Posted: 2019-07-18
• Primary Completion: 2021-02-22
• Study Completion: 2021-02-22
• Last Update Submitted: 2021-10-05
• Last Update Posted: 2021-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Age ≥18 years.
• Spine prone surgery lasting ≥2 hours.
• Absence of known pulmonary pathology.

Exclusion Criteria

• Pregnancy or lactation.
• Contraindication to alveolar recruitment maneuvers (risk of barotrauma, hemodynamic instability).
• Body mass index (BMI) >35.
• Heart failure defined as IC <2.5 L/min/m2 and/or inotropic support requirements prior to surgery.
• Diagnosis or suspicion of intracranial hypertension (intracranial pressure >15 mmHg).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Positive End-Expiratory Pressure (PEEP)	From determination of optimal PEEP until the first hour and then every hour, assessed up to the end of surgery (maximum 6 hours)	Variation of Positive End-Expiratory Pressure (cmH2O) during surgery in prone position with respect to PEEP value at 10 minutes after positioning
Positive End-Expiratory Pressure (PEEP)	10 minutes after positioning	Positive End-Expiratory Pressure (cmH2O) in prone position

Secondary Outcome Measures

Name	Time	Method
Arterial oxygen pressure (PaO2)	10 minutes after positioning	Partial pressure of oxygen (mmHg) in prone position
Change in static compliance	Measured at the same time as Auto PEEP until the first hour and then every hour, assessed up to the end of surgery (maximum 6 hours)	Variation of static compliance (Tidal volume / Plateau pressure ratio, in mL/cmH2O) during surgery in prone position
Arterial carbon dioxide pressure (PaCO2)	10 minutes after positioning	Partial pressure of carbon dioxide (mmHg) in prone position
Change in arterial carbon dioxide pressure (PaCO2)	Measured at the same time as Auto PEEP until the first hour and then every hour, assessed up to the end of surgery (maximum 6 hours)	Variation of partial pressure of carbon dioxide (mmHg) during surgery in prone position
Static compliance	10 minutes after positioning	Tidal volume / Plateau pressure ratio (mL/cmH2O) in prone position
Change in arterial oxygen pressure (PaO2)	Measured at the same time as Auto PEEP until the first hour and then every hour, assessed up to the end of surgery (maximum 6 hours)	Variation of partial pressure of oxygen (mmHg) during surgery in prone position

Trial Locations

Locations (1)

Hospital del Mar; 🇪🇸 Barcelona, Spain