Clinical trial NCT04024410: Optimal Positive End-expiratory Pressure (PEEP) in Prone Position During Spine Surgery
Official title: Optimal Positive End-expiratory Pressure (PEEP) in Prone Position During Spine Surgery. A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Surgery
Keywords: prone position
anesthesia, general
end-expiratory pressure, positive
respiration, artificial
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2019-07-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for spine surgery that requires prone decubitus.

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

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) \>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).

Primary outcomes:
measure: Positive End-Expiratory Pressure (PEEP)
timeFrame: 10 minutes after intubation
measure: Positive End-Expiratory Pressure (PEEP)
timeFrame: 10 minutes after positioning
measure: Change in Positive End-Expiratory Pressure (PEEP)
timeFrame: From determination of optimal PEEP until the first hour and then every hour, assessed up to the end of surgery (maximum 6 hours)
Secondary outcomes:
measure: Static compliance
timeFrame: 10 minutes after intubation
measure: Static compliance
timeFrame: 10 minutes after positioning
measure: Change in static compliance
timeFrame: 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)
measure: Arterial oxygen pressure (PaO2)
timeFrame: 10 minutes after intubation
measure: Arterial oxygen pressure (PaO2)
timeFrame: 10 minutes after positioning
measure: Change in arterial oxygen pressure (PaO2)
timeFrame: 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)
measure: Arterial carbon dioxide pressure (PaCO2)
timeFrame: 10 minutes after intubation
measure: Arterial carbon dioxide pressure (PaCO2)
timeFrame: 10 minutes after positioning
measure: Change in arterial carbon dioxide pressure (PaCO2)
timeFrame: 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)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar
Study officials:
affiliation: Hospital del Mar (Barcelona, Spain)
name: Lluís Gallart, Dr
role: PRINCIPAL_INVESTIGATOR
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