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

NCT04024410 | Completed

• 1 other identifier: 2018/8270/I
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Surgery

Keywords

prone position; anesthesia, general; end-expiratory pressure, positive; respiration, artificial

Outcome Measures

Primary Outcomes (3)

• Positive End-Expiratory Pressure (PEEP)

  Positive End-Expiratory Pressure (cmH2O) in supine position

  10 minutes after intubation

• Positive End-Expiratory Pressure (PEEP)

  Positive End-Expiratory Pressure (cmH2O) in prone position

  10 minutes after positioning

• Change in Positive End-Expiratory Pressure (PEEP)

  Variation of Positive End-Expiratory Pressure (cmH2O) during surgery in prone position with respect to PEEP value at 10 minutes after positioning

  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 (9)

• Static compliance

  10 minutes after intubation

• Static compliance

  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 oxygen pressure (PaO2)

  10 minutes after intubation

• Arterial oxygen pressure (PaO2)

  10 minutes after positioning

Interventions

Evaluation of PEEP in prone position OTHER

Assessment of optimal Positive End-Expiratory Pressure (PEEP) in patients undergoing scheduled spine surgery in prone position.

Eligibility Criteria

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

Study Population

Patients scheduled for spine surgery that requires prone decubitus.

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Hospital del Mar

Barcelona, 08003, Spain

Location

Related Publications (24)

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MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lluís Gallart, Dr

  Hospital del Mar (Barcelona, Spain)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 18, 2019
• Study Start: June 3, 2019
• Primary Completion: February 22, 2021
• Study Completion: February 22, 2021
• Last Updated: October 13, 2021

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)