- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04024410
Optimal Positive End-expiratory Pressure (PEEP) in Prone Position During Spine Surgery (OPTIPRONE)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Barcelona, Spain, 08003
- Hospital del Mar
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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).
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive End-Expiratory Pressure (PEEP)
Time Frame: 10 minutes after intubation
|
Positive End-Expiratory Pressure (cmH2O) in supine position
|
10 minutes after intubation
|
Positive End-Expiratory Pressure (PEEP)
Time Frame: 10 minutes after positioning
|
Positive End-Expiratory Pressure (cmH2O) in prone position
|
10 minutes after positioning
|
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
|
From determination of optimal PEEP until the first hour and then every hour, assessed up to the end of surgery (maximum 6 hours)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Static compliance
Time Frame: 10 minutes after intubation
|
Tidal volume / Plateau pressure ratio (mL/cmH2O) in supine position
|
10 minutes after intubation
|
Static compliance
Time Frame: 10 minutes after positioning
|
Tidal volume / Plateau pressure ratio (mL/cmH2O) in prone position
|
10 minutes after positioning
|
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
|
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)
Time Frame: 10 minutes after intubation
|
Partial pressure of oxygen (mmHg) in supine position
|
10 minutes after intubation
|
Arterial oxygen pressure (PaO2)
Time Frame: 10 minutes after positioning
|
Partial pressure of oxygen (mmHg) in prone position
|
10 minutes after positioning
|
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
|
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 carbon dioxide pressure (PaCO2)
Time Frame: 10 minutes after intubation
|
Partial pressure of carbon dioxide (mmHg) in supine position
|
10 minutes after intubation
|
Arterial carbon dioxide pressure (PaCO2)
Time Frame: 10 minutes after positioning
|
Partial pressure of carbon dioxide (mmHg) in prone position
|
10 minutes after positioning
|
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
|
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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lluís Gallart, Dr, Hospital del Mar (Barcelona, Spain)
Publications and helpful links
General Publications
- 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.
- 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.
- Ferrando C, Mugarra A, Gutierrez A, Carbonell JA, Garcia M, Soro M, Tusman G, Belda FJ. Setting individualized positive end-expiratory pressure level with a positive end-expiratory pressure decrement trial after a recruitment maneuver improves oxygenation and lung mechanics during one-lung ventilation. Anesth Analg. 2014 Mar;118(3):657-65. doi: 10.1213/ANE.0000000000000105.
- 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. Erratum In: N Engl J Med. 2014 Apr 24;370(17):1668-9.
- 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.
- Duggan M, Kavanagh BP. Pulmonary atelectasis: a pathogenic perioperative entity. Anesthesiology. 2005 Apr;102(4):838-54. doi: 10.1097/00000542-200504000-00021.
- 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.
- 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.
- 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.
- 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.
- 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.
- Gattinoni L, Caironi P. Prone positioning: beyond physiology. Anesthesiology. 2010 Dec;113(6):1262-4. doi: 10.1097/ALN.0b013e3181fcd97e. No abstract available.
- 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.
- 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.
- Mure M, Domino KB, Lindahl SG, Hlastala MP, Altemeier WA, Glenny RW. 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.
- 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.
- Pelosi P, Croci M, Calappi E, Mulazzi D, Cerisara M, Vercesi P, Vicardi P, Gattinoni L. Prone positioning improves pulmonary function in obese patients during general anesthesia. Anesth Analg. 1996 Sep;83(3):578-83. doi: 10.1097/00000539-199609000-00025.
- Petersson J, Ax M, Frey J, Sanchez-Crespo A, Lindahl SG, Mure M. Positive end-expiratory pressure redistributes regional blood flow and ventilation differently in supine and prone humans. Anesthesiology. 2010 Dec;113(6):1361-9. doi: 10.1097/ALN.0b013e3181fcec4f.
- Beitler JR, Guerin C, Ayzac L, Mancebo J, Bates DM, Malhotra A, Talmor D. PEEP titration during prone positioning for acute respiratory distress syndrome. Crit Care. 2015 Dec 21;19:436. doi: 10.1186/s13054-015-1153-9.
- 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.
- Spaeth J, Daume K, Goebel U, Wirth S, Schumann S. Increasing positive end-expiratory pressure (re-)improves intraoperative respiratory mechanics and lung ventilation after prone positioning. Br J Anaesth. 2016 Jun;116(6):838-46. doi: 10.1093/bja/aew115.
- Katoh T, Suguro Y, Ikeda T, Kazama T, Ikeda K. Influence of age on awakening concentrations of sevoflurane and isoflurane. Anesth Analg. 1993 Feb;76(2):348-52.
- Pelosi P, Gama de Abreu M, Rocco PR. New and conventional strategies for lung recruitment in acute respiratory distress syndrome. Crit Care. 2010;14(2):210. doi: 10.1186/cc8851. Epub 2010 Mar 9.
- Mahajan RP, Hennessy N, Aitkenhead AR, Jellinek D. Effect of three different surgical prone positions on lung volumes in healthy volunteers. Anaesthesia. 1994 Jul;49(7):583-6. doi: 10.1111/j.1365-2044.1994.tb14224.x.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2018/8270/I
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Surgery
-
3MRecruitingAbdominal Surgery | Orthopedic Surgery | Vascular Surgery | Cardiovascular SurgeryUnited States
-
Vanderbilt UniversityCompletedHand Surgery | Wrist Surgery | Forearm Surgery | Elbow SurgeryUnited States
-
Nantes University HospitalCompletedGynecological Surgery | Plastic Surgery | ENT SurgeryFrance
-
Edwards LifesciencesCompletedAbdominal Surgery | Pelvic Surgery | Non-Cardiac/ Non-Thoracic Surgery | Major Peripheral Vascular SurgeryUnited States
-
Maquet Cardiopulmonary GmbHNAMSARecruitingCardiac Surgery | Cardiopulmonary Bypass | Thoracic Surgery | Vascular SurgerySpain
-
Baylor Research InstituteChiesi USA, Inc.RecruitingSurgery | Cardiac Surgery | Surgery--Complications | Percutaneous Coronary InterventionUnited States
-
Vanderbilt UniversityEdwards LifesciencesCompletedCardiac Surgery | Thoracic Surgery | Heart Surgery | Heart Transplant
-
Surgify Medical OyCompletedSurgery | Spine SurgeryFinland
-
Cairo UniversityBatterjee Medical College; Taif UniversityCompletedSurgery | Bariatric SurgeryEgypt, Saudi Arabia
-
Poudre Valley Health SystemTerminatedSurgery | Surgery--ComplicationsUnited States
Clinical Trials on Evaluation of PEEP in prone position
-
Seoul National University HospitalCompleted
-
University Hospital, GhentNational Cancer Plan, FranceCompleted
-
Sahlgrenska University Hospital, SwedenActive, not recruitingPulmonary AtelectasisSweden
-
VA Connecticut Healthcare SystemUS Department of Veterans AffairsCompleted
-
Bicetre HospitalUnknownAcute Respiratory Distress Syndrome | Acute Respiratory Distress Syndrome in Adult or Child
-
Lorenzo delSorboNot yet recruiting
-
Prof. Dr. Cemil Tascıoglu Education and Research...Completed
-
Assistance Publique Hopitaux De MarseilleCompleted
-
Xiangya Hospital of Central South UniversityNational Natural Science Foundation of ChinaUnknown
-
Saglik Bilimleri Universitesi Gulhane Tip FakultesiCompletedNursing Caries | PretermTurkey