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Clinical Trials/NCT04024410
NCT04024410
Completed
Not Applicable

Optimal Positive End-expiratory Pressure (PEEP) in Prone Position During Spine Surgery. A Prospective Observational Study

Parc de Salut Mar1 site in 1 country20 target enrollmentJune 3, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia
Sponsor
Parc de Salut Mar
Enrollment
20
Locations
1
Primary Endpoint
Change in Positive End-Expiratory Pressure (PEEP)
Status
Completed
Last Updated
4 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
June 3, 2019
End Date
February 22, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Parc de Salut Mar
Responsible Party
Sponsor

Eligibility Criteria

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) \>
  • 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).

Outcomes

Primary Outcomes

Change in Positive End-Expiratory Pressure (PEEP)

Time Frame: 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)

Time Frame: 10 minutes after positioning

Positive End-Expiratory Pressure (cmH2O) in prone position

Secondary Outcomes

  • Arterial oxygen pressure (PaO2)(10 minutes after positioning)
  • 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))
  • Arterial carbon dioxide pressure (PaCO2)(10 minutes after positioning)
  • 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))
  • Static compliance(10 minutes after positioning)
  • 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))

Study Sites (1)

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