AzTrials
AzTrials

AnesthesiaOPTIPRONENCT04024410

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

An observational study of Anesthesia and Surgery, run by Parc de Salut Mar at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anesthesia, Surgery
What is being tested?
Evaluation of PEEP in prone position
How many people
20 participants
Where
1 siteSpain
Study dates
3 Jun 2019to 22 Feb 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients scheduled for spine surgery that requires prone decubitus.

Who may be able to join

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

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital del Mar

    Barcelona, 08003

Other trials in Spain

About this study

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

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.

Read the 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

Conditions
Anesthesia, Surgery
Being tested
Evaluation of PEEP in prone position
Keywords
prone position, anesthesia, general, end-expiratory pressure, positive, respiration, artificial
Medical subject headings
Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Evaluation of PEEP in prone positionOther

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Positive End-Expiratory Pressure (PEEP)

    Positive End-Expiratory Pressure (cmH2O) in supine position

    Measured: 10 minutes after intubation

  2. Positive End-Expiratory Pressure (PEEP)

    Positive End-Expiratory Pressure (cmH2O) in prone position

    Measured: 10 minutes after positioning

  3. 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

    Measured: 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)

  1. Static compliance

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

    Measured: 10 minutes after intubation

  2. Static compliance

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

    Measured: 10 minutes after positioning

  3. Change in static compliance

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

    Measured: 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)

  4. Arterial oxygen pressure (PaO2)

    Partial pressure of oxygen (mmHg) in supine position

    Measured: 10 minutes after intubation

  5. Arterial oxygen pressure (PaO2)

    Partial pressure of oxygen (mmHg) in prone position

    Measured: 10 minutes after positioning

  6. Change in arterial oxygen pressure (PaO2)

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

    Measured: 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)

  7. Arterial carbon dioxide pressure (PaCO2)

    Partial pressure of carbon dioxide (mmHg) in supine position

    Measured: 10 minutes after intubation

  8. Arterial carbon dioxide pressure (PaCO2)

    Partial pressure of carbon dioxide (mmHg) in prone position

    Measured: 10 minutes after positioning

  9. Change in arterial carbon dioxide pressure (PaCO2)

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

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2019
  2. Study start3 Jun 2019
  3. Primary completion22 Feb 2021
  4. Study completion22 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04024410
Sponsor's protocol ID
2018/8270/I
Acronym
OPTIPRONE
Status last verified
Jun 2019
First submitted
27 Jun 2019
Last updated
13 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2013 Nov 28;369(22):2126-36. doi: 10.1056/NEJMra1208707. No abstract available.

    PubMed 24283226

  • Canet J, Gallart L, Gomar C, Paluzie G, Valles J, Castillo J, Sabate S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a.

    PubMed 21045639

  • Serpa Neto A, Cardoso SO, Manetta JA, Pereira VG, Esposito DC, Pasqualucci Mde O, Damasceno MC, Schultz MJ. Association between use of lung-protective ventilation with lower tidal volumes and clinical outcomes among patients without acute respiratory distress syndrome: a meta-analysis. JAMA. 2012 Oct 24;308(16):1651-9. doi: 10.1001/jama.2012.13730.

    PubMed 23093163

  • Duggan M, Kavanagh BP. Pulmonary atelectasis: a pathogenic perioperative entity. Anesthesiology. 2005 Apr;102(4):838-54. doi: 10.1097/00000542-200504000-00021.

    PubMed 15791115

  • Goldenberg NM, Steinberg BE, Lee WL, Wijeysundera DN, Kavanagh BP. Lung-protective ventilation in the operating room: time to implement? Anesthesiology. 2014 Jul;121(1):184-8. doi: 10.1097/ALN.0000000000000274. No abstract available.

    PubMed 24781494

  • Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.

    PubMed 23902482

  • Coppola S, Froio S, Chiumello D. Protective lung ventilation during general anesthesia: is there any evidence? Crit Care. 2014 Mar 18;18(2):210. doi: 10.1186/cc13777. No abstract available.

    PubMed 25029254

  • Ladha K, Vidal Melo MF, McLean DJ, Wanderer JP, Grabitz SD, Kurth T, Eikermann M. Intraoperative protective mechanical ventilation and risk of postoperative respiratory complications: hospital based registry study. BMJ. 2015 Jul 14;351:h3646. doi: 10.1136/bmj.h3646.

    PubMed 26174419

  • Hemmes SN, Serpa Neto A, Schultz MJ. Intraoperative ventilatory strategies to prevent postoperative pulmonary complications: a meta-analysis. Curr Opin Anaesthesiol. 2013 Apr;26(2):126-33. doi: 10.1097/ACO.0b013e32835e1242.

    PubMed 23385321

  • Hemmes SN, Severgnini P, Jaber S, Canet J, Wrigge H, Hiesmayr M, Tschernko EM, Hollmann MW, Binnekade JM, Hedenstierna G, Putensen C, de Abreu MG, Pelosi P, Schultz MJ. Rationale and study design of PROVHILO - a worldwide multicenter randomized controlled trial on protective ventilation during general anesthesia for open abdominal surgery. Trials. 2011 May 6;12:111. doi: 10.1186/1745-6215-12-111.

    PubMed 21548927

  • Gattinoni L, Caironi P. Prone positioning: beyond physiology. Anesthesiology. 2010 Dec;113(6):1262-4. doi: 10.1097/ALN.0b013e3181fcd97e. No abstract available.

    PubMed 21042196

  • Pelosi P, Caironi P, Taccone P, Brazzi L. Pathophysiology of prone positioning in the healthy lung and in ALI/ARDS. Minerva Anestesiol. 2001 Apr;67(4):238-47.

    PubMed 11376516

  • Edgcombe H, Carter K, Yarrow S. Anaesthesia in the prone position. Br J Anaesth. 2008 Feb;100(2):165-83. doi: 10.1093/bja/aem380.

    PubMed 18211991

  • Mure M, Domino KB, Lindahl SG, Hlastala MP, Altemeier WA, Glenny RW; New Collective Author. Regional ventilation-perfusion distribution is more uniform in the prone position. J Appl Physiol (1985). 2000 Mar;88(3):1076-83. doi: 10.1152/jappl.2000.88.3.1076.

    PubMed 10710406

  • Pelosi P, Croci M, Calappi E, Cerisara M, Mulazzi D, Vicardi P, Gattinoni L. The prone positioning during general anesthesia minimally affects respiratory mechanics while improving functional residual capacity and increasing oxygen tension. Anesth Analg. 1995 May;80(5):955-60. doi: 10.1097/00000539-199505000-00017.

    PubMed 7726438

Questions about this trial

What is this clinical trial studying?

An observational study of Anesthesia and Surgery, run by Parc de Salut Mar at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positive End-Expiratory Pressure (PEEP) (time frame: 10 minutes after intubation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04024410, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in