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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04024410
Recruitment Status : Completed
First Posted : July 18, 2019
Last Update Posted : October 13, 2021
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Anesthesia Surgery Other: Evaluation of PEEP in prone 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

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Optimal Positive End-expiratory Pressure (PEEP) in Prone Position During Spine Surgery. A Prospective Observational Study
Actual Study Start Date : June 3, 2019
Actual Primary Completion Date : February 22, 2021
Actual Study Completion Date : February 22, 2021

Intervention Details:
  • Other: Evaluation of PEEP in prone position
    Assessment of optimal Positive End-Expiratory Pressure (PEEP) in patients undergoing scheduled spine surgery in prone position.


Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled for spine surgery that requires prone decubitus.
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04024410


Locations
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Spain
Hospital del Mar
Barcelona, Spain, 08003
Sponsors and Collaborators
Parc de Salut Mar
Investigators
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Principal Investigator: Lluís Gallart, Dr Hospital del Mar (Barcelona, Spain)
Publications:
Fan E, Del Sorbo L, Goligher EC, Hodgson CL, Munshi L, Walkey AJ, Adhikari NKJ, Amato MBP, Branson R, Brower RG, Ferguson ND, Gajic O, Gattinoni L, Hess D, Mancebo J, Meade MO, McAuley DF, Pesenti A, Ranieri VM, Rubenfeld GD, Rubin E, Seckel M, Slutsky AS, Talmor D, Thompson BT, Wunsch H, Uleryk E, Brozek J, Brochard LJ; American Thoracic Society, European Society of Intensive Care Medicine, and Society of Critical Care Medicine. An Official American Thoracic Society/European Society of Intensive Care Medicine/Society of Critical Care Medicine Clinical Practice Guideline: Mechanical Ventilation in Adult Patients with Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2017 May 1;195(9):1253-1263. doi: 10.1164/rccm.201703-0548ST. Erratum in: Am J Respir Crit Care Med. 2017 Jun 1;195(11):1540.

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Responsible Party: Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT04024410    
Other Study ID Numbers: 2018/8270/I
First Posted: July 18, 2019    Key Record Dates
Last Update Posted: October 13, 2021
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Parc de Salut Mar:
prone position
anesthesia, general
end-expiratory pressure, positive
respiration, artificial