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

Surgery Clinical Trial

— OPTIPRONE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04024410
• Other study ID #: 2018/8270/I
• Status: Completed
• Start date: June 3, 2019
• Est. completion date: February 22, 2021

Study information

• Verified date: June 2019
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 22, 2021
• Est. primary completion date: February 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Anesthesia
• Surgery

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital del Mar	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

References & Publications (24)

Beitler JR, Guérin 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. — View Citation

Canet J, Gallart L, Gomar C, Paluzie G, Vallès J, Castillo J, Sabaté 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. — View Citation

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. Review. — View Citation

Duggan M, Kavanagh BP. Pulmonary atelectasis: a pathogenic perioperative entity. Anesthesiology. 2005 Apr;102(4):838-54. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Ferrando C, Mugarra A, Gutierrez A, Carbonell JA, García 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. — View Citation

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. — View Citation

Gattinoni L, Caironi P. Prone positioning: beyond physiology. Anesthesiology. 2010 Dec;113(6):1262-4. doi: 10.1097/ALN.0b013e3181fcd97e. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Petersson J, Ax M, Frey J, Sánchez-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. — View Citation

Serpa Neto A, Cardoso SO, Manetta JA, Pereira VG, Espósito 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. — View Citation

Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2013 Nov 28;369(22):2126-36. doi: 10.1056/NEJMra1208707. Review. Erratum in: N Engl J Med. 2014 Apr 24;370(17):1668-9. — View Citation

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. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive End-Expiratory Pressure (PEEP)	Positive End-Expiratory Pressure (cmH2O) in supine position	10 minutes after intubation
Primary	Positive End-Expiratory Pressure (PEEP)	Positive End-Expiratory Pressure (cmH2O) in prone position	10 minutes after positioning
Primary	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	From determination of optimal PEEP until the first hour and then every hour, assessed up to the end of surgery (maximum 6 hours)
Secondary	Static compliance	Tidal volume / Plateau pressure ratio (mL/cmH2O) in supine position	10 minutes after intubation
Secondary	Static compliance	Tidal volume / Plateau pressure ratio (mL/cmH2O) in prone position	10 minutes after positioning
Secondary	Change in static compliance	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)
Secondary	Arterial oxygen pressure (PaO2)	Partial pressure of oxygen (mmHg) in supine position	10 minutes after intubation
Secondary	Arterial oxygen pressure (PaO2)	Partial pressure of oxygen (mmHg) in prone position	10 minutes after positioning
Secondary	Change in arterial oxygen pressure (PaO2)	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)
Secondary	Arterial carbon dioxide pressure (PaCO2)	Partial pressure of carbon dioxide (mmHg) in supine position	10 minutes after intubation
Secondary	Arterial carbon dioxide pressure (PaCO2)	Partial pressure of carbon dioxide (mmHg) in prone position	10 minutes after positioning
Secondary	Change in arterial carbon dioxide pressure (PaCO2)	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)