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Completed

NCT Number: NCT04024410

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

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.

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Key information

Conditions

Anesthesia Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital del Mar

Barcelona, 08003, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Evaluation of PEEP in prone position

Other

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

Primary outcomes

  1. Positive End-Expiratory Pressure (PEEP)

    Time frame: 10 minutes after intubation

    Positive End-Expiratory Pressure (cmH2O) in supine position

  2. Positive End-Expiratory Pressure (PEEP)

    Time frame: 10 minutes after positioning

    Positive End-Expiratory Pressure (cmH2O) in prone position

  3. 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

Secondary outcomes

  1. Static compliance

    Time frame: 10 minutes after intubation

    Tidal volume / Plateau pressure ratio (mL/cmH2O) in supine position

  2. Static compliance

    Time frame: 10 minutes after positioning

    Tidal volume / Plateau pressure ratio (mL/cmH2O) in prone position

  3. Change in static compliance

    Time frame: 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

  4. Arterial oxygen pressure (PaO2)

    Time frame: 10 minutes after intubation

    Partial pressure of oxygen (mmHg) in supine position

  5. Arterial oxygen pressure (PaO2)

    Time frame: 10 minutes after positioning

    Partial pressure of oxygen (mmHg) in prone position

  6. Change in arterial oxygen pressure (PaO2)

    Time frame: 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

  7. Arterial carbon dioxide pressure (PaCO2)

    Time frame: 10 minutes after intubation

    Partial pressure of carbon dioxide (mmHg) in supine position

  8. Arterial carbon dioxide pressure (PaCO2)

    Time frame: 10 minutes after positioning

    Partial pressure of carbon dioxide (mmHg) in prone position

  9. Change in arterial carbon dioxide pressure (PaCO2)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Registry information

Official study title

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

Acronym: OPTIPRONE

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 18, 2019
Registry last updated
Oct 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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