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

Sponsor
Parc de Salut Mar (Other)
Overall Status
Completed
CT.gov ID
NCT04024410
Collaborator
(none)
20
Enrollment
1
Location
20.7
Actual Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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

Study Design

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 :
Jun 3, 2019
Actual Primary Completion Date :
Feb 22, 2021
Actual Study Completion Date :
Feb 22, 2021

Outcome Measures

Primary Outcome Measures

  1. Positive End-Expiratory Pressure (PEEP) [10 minutes after intubation]

    Positive End-Expiratory Pressure (cmH2O) in supine position

  2. Positive End-Expiratory Pressure (PEEP) [10 minutes after positioning]

    Positive End-Expiratory Pressure (cmH2O) in prone position

  3. Change in Positive End-Expiratory Pressure (PEEP) [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 [10 minutes after intubation]

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

  2. Static compliance [10 minutes after positioning]

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

  3. 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)]

    Variation of static compliance (Tidal volume / Plateau pressure ratio, in mL/cmH2O) during surgery in prone position

  4. Arterial oxygen pressure (PaO2) [10 minutes after intubation]

    Partial pressure of oxygen (mmHg) in supine position

  5. Arterial oxygen pressure (PaO2) [10 minutes after positioning]

    Partial pressure of oxygen (mmHg) in prone position

  6. 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)]

    Variation of partial pressure of oxygen (mmHg) during surgery in prone position

  7. Arterial carbon dioxide pressure (PaCO2) [10 minutes after intubation]

    Partial pressure of carbon dioxide (mmHg) in supine position

  8. Arterial carbon dioxide pressure (PaCO2) [10 minutes after positioning]

    Partial pressure of carbon dioxide (mmHg) in prone position

  9. 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)]

    Variation of partial pressure of carbon dioxide (mmHg) during surgery in prone position

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital del Mar Barcelona Spain 08003

Sponsors and Collaborators

  • Parc de Salut Mar

Investigators

  • Principal Investigator: Lluís Gallart, Dr, Hospital del Mar (Barcelona, Spain)

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Parc de Salut Mar
ClinicalTrials.gov Identifier:
NCT04024410
Other Study ID Numbers:
  • 2018/8270/I
First Posted:
Jul 18, 2019
Last Update Posted:
Oct 13, 2021
Last Verified:
Jun 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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

Study Results

No Results Posted as of Oct 13, 2021