Skip to main content
Top
Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

The effect of an intraoperative, lung-protective ventilation strategy in neurosurgical patients undergoing craniotomy: study protocol for a randomized controlled trial

Authors: Liyong Zhang, Wei Xiong, Yuming Peng, Wei Zhang, Ruquan Han

Published in: Trials | Issue 1/2018

Login to get access

Abstract

Background

Ventilator-induced lung injury is a major cause of postoperative pulmonary complications (PPCs) in patients undergoing neurosurgery after general anesthesia. However, there is no study on the effect of a lung-protective ventilation strategy in patients undergoing neurosurgery.

Methods

This is a single-center, randomized, parallel-group controlled trial which will be carried out at Beijing Tiantan Hospital, Capital Medical University. Three hundred and thirty-four patients undergoing intracranial tumor surgery will be randomly allocated to the control group and the protective-ventilation strategy group. In the control group, tidal volume (VT) will be set at 10–12 ml/kg of predicted body weight but PEEP and recruitment maneuvers will not be used. In the protective group, VT will be set at 6–8 ml/kg of predicted body weight, PEEP at 6–8 cmH2O, and a recruitment maneuver will be used intermittently. The primary outcome is pulmonary complications within 7 days postoperatively. Secondary outcomes include intraoperative brain relaxation, the postoperative complications within 30 days and the cost analysis.

Discussion

This study aims to determine if the protective, pulmonary-ventilation strategy decreases the incidence of PPCs in patients undergoing neurosurgical anesthesia. If our results are positive, the study will indicate whether the protective, pulmonary-ventilation strategy is efficiently and safely used in neurosurgical patients undergoing the craniotomy.

Trial registration

ClinicalTrials.gov, ID: NCT02386683. Registered on 18 October 2014.
Appendix
Available only for authorised users
Literature
1.
go back to reference Weiser TG, Regenbogen SE, Thompson KD, Haynes AB, Berry WR, Gawande AA. An estimation of the global volume of surgery: a modeling strategy based on available data. Lancet. 2008;372:139–44.CrossRefPubMed Weiser TG, Regenbogen SE, Thompson KD, Haynes AB, Berry WR, Gawande AA. An estimation of the global volume of surgery: a modeling strategy based on available data. Lancet. 2008;372:139–44.CrossRefPubMed
2.
go back to reference Fernandez-Bustamante A, Frendl G, Sprung J, Subramaniam B, Martinez Ruiz R, Lee JW, Henderson WG, Moss A, Mehdiratta N, Colwell MM, Bartels K, Kolodzie K, Giquel J, Vidal Melo MF. Postoperative pulmonary complications, early mortality, and hospital stay following noncardiothoracic surgery: a multicenter study by the perioperative research network investigators. JAMA Surg. 2017;152(2):157–66.CrossRefPubMedPubMedCentral Fernandez-Bustamante A, Frendl G, Sprung J, Subramaniam B, Martinez Ruiz R, Lee JW, Henderson WG, Moss A, Mehdiratta N, Colwell MM, Bartels K, Kolodzie K, Giquel J, Vidal Melo MF. Postoperative pulmonary complications, early mortality, and hospital stay following noncardiothoracic surgery: a multicenter study by the perioperative research network investigators. JAMA Surg. 2017;152(2):157–66.CrossRefPubMedPubMedCentral
3.
4.
go back to reference Arozullah AM, Daley J, Henderson WG, Khuri SF. Multifactorial risk index for predicting postoperative respiratory failure in men after major noncardiac surgery: the National Veterans Administration Surgical Quality Improvement Program. Ann Surg. 2000;232:242–53.CrossRefPubMedPubMedCentral Arozullah AM, Daley J, Henderson WG, Khuri SF. Multifactorial risk index for predicting postoperative respiratory failure in men after major noncardiac surgery: the National Veterans Administration Surgical Quality Improvement Program. Ann Surg. 2000;232:242–53.CrossRefPubMedPubMedCentral
5.
go back to reference Shander A, Fleisher LA, Barie PS, Bigatello LM, Sladen RN, Watson CB. Clinical and economic burden of postoperative pulmonary complications: patient safety summit on definition, risk-reducing interventions, and preventive strategies. Crit Care Med. 2011;39:2163–72.CrossRefPubMed Shander A, Fleisher LA, Barie PS, Bigatello LM, Sladen RN, Watson CB. Clinical and economic burden of postoperative pulmonary complications: patient safety summit on definition, risk-reducing interventions, and preventive strategies. Crit Care Med. 2011;39:2163–72.CrossRefPubMed
6.
go back to reference Hedenstierna G, Edmark L. The effects of anesthesia and muscle paralysis on the respiratory system. Intensive Care Med. 2005;31:1327–35.CrossRefPubMed Hedenstierna G, Edmark L. The effects of anesthesia and muscle paralysis on the respiratory system. Intensive Care Med. 2005;31:1327–35.CrossRefPubMed
7.
go back to reference Bendixen HH, Hedley-Whyte J, Laver MB. Impaired oxygenation in surgical patients during general anesthesia with controlled ventilation. A concept of atelectasis. N Engl J Med. 1963;269:991–6.CrossRefPubMed Bendixen HH, Hedley-Whyte J, Laver MB. Impaired oxygenation in surgical patients during general anesthesia with controlled ventilation. A concept of atelectasis. N Engl J Med. 1963;269:991–6.CrossRefPubMed
8.
go back to reference Wrigge H, Pelosi P. Tidal volume in patients with normal lungs during general anesthesia: lower the better? Anesthesiology. 2011;114:1011–3.CrossRefPubMed Wrigge H, Pelosi P. Tidal volume in patients with normal lungs during general anesthesia: lower the better? Anesthesiology. 2011;114:1011–3.CrossRefPubMed
9.
go back to reference Blum JM, Fetterman DM, Park PK, Morris M, Rosenberg AL. A description of intraoperative ventilator management and ventilation strategies in hypoxic patients. Anesth Analg. 2010;110:1616–22.CrossRefPubMed Blum JM, Fetterman DM, Park PK, Morris M, Rosenberg AL. A description of intraoperative ventilator management and ventilation strategies in hypoxic patients. Anesth Analg. 2010;110:1616–22.CrossRefPubMed
10.
go back to reference Lellouche F, Dionne S, Simard S, Bussières J, Dagenais F. High tidal volumes in mechanically ventilated patients increase organ dysfunction after cardiac surgery. Anesthesiology. 2012;116:1072–82.CrossRefPubMed Lellouche F, Dionne S, Simard S, Bussières J, Dagenais F. High tidal volumes in mechanically ventilated patients increase organ dysfunction after cardiac surgery. Anesthesiology. 2012;116:1072–82.CrossRefPubMed
11.
go back to reference Tremblay LN, Slutsky AS. Pathogenesis of ventilator-induced lung injury: trials and tribulations. Am J Physiol Lung Cell Mol Physiol. 2005;288:L596–8.CrossRefPubMed Tremblay LN, Slutsky AS. Pathogenesis of ventilator-induced lung injury: trials and tribulations. Am J Physiol Lung Cell Mol Physiol. 2005;288:L596–8.CrossRefPubMed
12.
go back to reference De Prost N, Costa EL, Wellman T, Musch G, Tucci MR, Winkler T, Harris R, Venegas JG, Kavanagh BP, Vidal Melo MF. Effects of ventilation strategy on distribution of lung inflammatory cell activity. Crit Care. 2013;17:R175.CrossRefPubMedPubMedCentral De Prost N, Costa EL, Wellman T, Musch G, Tucci MR, Winkler T, Harris R, Venegas JG, Kavanagh BP, Vidal Melo MF. Effects of ventilation strategy on distribution of lung inflammatory cell activity. Crit Care. 2013;17:R175.CrossRefPubMedPubMedCentral
13.
go back to reference Kroon AA, Delriccio V, Tseu I, Kavanagh BP, Post M. Mechanical ventilation-induced apoptosis in newborn rat lung is mediated via FasL/Fas pathway. Am J Physiol Lung Cell Mol Physiol. 2013;305:L795–804.CrossRefPubMed Kroon AA, Delriccio V, Tseu I, Kavanagh BP, Post M. Mechanical ventilation-induced apoptosis in newborn rat lung is mediated via FasL/Fas pathway. Am J Physiol Lung Cell Mol Physiol. 2013;305:L795–804.CrossRefPubMed
14.
go back to reference Gurkan OU, O’Donnell C, Brower R, Ruckdeschel E, Becker PM. Differential effects of mechanical ventilatory strategy on lung injury and systemic organ inflammation in mice. Am J Physiol Lung Cell Mol Physiol. 2003;285:L710–8.CrossRefPubMed Gurkan OU, O’Donnell C, Brower R, Ruckdeschel E, Becker PM. Differential effects of mechanical ventilatory strategy on lung injury and systemic organ inflammation in mice. Am J Physiol Lung Cell Mol Physiol. 2003;285:L710–8.CrossRefPubMed
15.
go back to reference Tojo K, Nagamine Y, Yazawa T, Mihara T, Baba Y, Ota S, Goto T, Kurahashi K. Atelectasis causes alveolar hypoxia-induced inflammation during uneven mechanical ventilation in rats. Intensive Care Med Exp. 2015;3(1):56.CrossRefPubMed Tojo K, Nagamine Y, Yazawa T, Mihara T, Baba Y, Ota S, Goto T, Kurahashi K. Atelectasis causes alveolar hypoxia-induced inflammation during uneven mechanical ventilation in rats. Intensive Care Med Exp. 2015;3(1):56.CrossRefPubMed
16.
go back to reference Lu Q. How to assess positive end-expiratory pressure-induced alveolar recruitment? Minerva Anestesiol. 2013;79(1):83–91.PubMed Lu Q. How to assess positive end-expiratory pressure-induced alveolar recruitment? Minerva Anestesiol. 2013;79(1):83–91.PubMed
17.
go back to reference Chikhani M, Das A, Haque M, Wang W, Bates DG, Hardman JG. High PEEP in acute respiratory distress syndrome: quantitative evaluation between improved arterial oxygenation and decreased oxygen delivery. Br J Anaesth. 2016;117(5):650–8.CrossRefPubMedPubMedCentral Chikhani M, Das A, Haque M, Wang W, Bates DG, Hardman JG. High PEEP in acute respiratory distress syndrome: quantitative evaluation between improved arterial oxygenation and decreased oxygen delivery. Br J Anaesth. 2016;117(5):650–8.CrossRefPubMedPubMedCentral
18.
go back to reference Cho YJ, Moon JY, Shin ES, Kim JH, Jung H, Park SY, Kim HC, Sim YS, Rhee CK, Lim J, Lee SJ, Lee WY, Lee HJ, Kwak SH, Kang EK, Chung KS, Choi WI. Clinical practice guideline of acute respiratory distress syndrome. Tuberc Respir Dis (Seoul). 2016;79(4):214–33.CrossRef Cho YJ, Moon JY, Shin ES, Kim JH, Jung H, Park SY, Kim HC, Sim YS, Rhee CK, Lim J, Lee SJ, Lee WY, Lee HJ, Kwak SH, Kang EK, Chung KS, Choi WI. Clinical practice guideline of acute respiratory distress syndrome. Tuberc Respir Dis (Seoul). 2016;79(4):214–33.CrossRef
19.
go back to reference Bime C, Fiero M, Lu Z, Oren E, Berry CE, Parthasarathy S, Garcia JG. High positive end-expiratory pressure is associated with improved survival in obese patients with acute respiratory distress syndrome. Am J Med. 2017;130(2):207–13.CrossRefPubMed Bime C, Fiero M, Lu Z, Oren E, Berry CE, Parthasarathy S, Garcia JG. High positive end-expiratory pressure is associated with improved survival in obese patients with acute respiratory distress syndrome. Am J Med. 2017;130(2):207–13.CrossRefPubMed
20.
go back to reference Dellinger RP, Levy MM, Carlet JM, Bion J, Parker MM, Jaeschke R, Reinhart K, Angus DC, Brun-Buisson C, Beale R, Calandra T, Dhainaut JF, Gerlach H, Harvey M, Marini JJ, Marshall J, Ranieri M, Ramsay G, Sevransky J, Thompson BT, Townsend S, Vender JS, Zimmerman JL, Vincent JL. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock: 2008. Crit Care Med. 2008;36:296–327.CrossRefPubMed Dellinger RP, Levy MM, Carlet JM, Bion J, Parker MM, Jaeschke R, Reinhart K, Angus DC, Brun-Buisson C, Beale R, Calandra T, Dhainaut JF, Gerlach H, Harvey M, Marini JJ, Marshall J, Ranieri M, Ramsay G, Sevransky J, Thompson BT, Townsend S, Vender JS, Zimmerman JL, Vincent JL. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock: 2008. Crit Care Med. 2008;36:296–327.CrossRefPubMed
21.
go back to reference Sundar S, Novack V, Jervis K, Bender SP, Lerner A, Panzica P, Mahmood F, Malhotra A, Talmor D. Influence of low tidal volume ventilation on time to extubation in cardiac surgical patients. Anesthesiology. 2011;114:1102–10.CrossRefPubMedPubMedCentral Sundar S, Novack V, Jervis K, Bender SP, Lerner A, Panzica P, Mahmood F, Malhotra A, Talmor D. Influence of low tidal volume ventilation on time to extubation in cardiac surgical patients. Anesthesiology. 2011;114:1102–10.CrossRefPubMedPubMedCentral
22.
go back to reference Treschan TA, Kaisers W, Schaefer MS, Bastin B, Schmalz U, Wania V, Eisenberger CF, Saleh A, Weiss M, Schmitz A, Kienbaum P, Sessler DI, Pannen B, Beiderlinden M. Ventilation with low tidal volumes during upper abdominal surgery does not improve postoperative lung function. Br J Anaesth. 2012;109:263–71.CrossRefPubMed Treschan TA, Kaisers W, Schaefer MS, Bastin B, Schmalz U, Wania V, Eisenberger CF, Saleh A, Weiss M, Schmitz A, Kienbaum P, Sessler DI, Pannen B, Beiderlinden M. Ventilation with low tidal volumes during upper abdominal surgery does not improve postoperative lung function. Br J Anaesth. 2012;109:263–71.CrossRefPubMed
23.
go back to reference Severgnini P, Selmo G, Lanza C, Chiesa A, Frigerio A, Bacuzzi A, Dionigi G, Novario R, Gregoretti C, de Abreu MG, Schultz MJ, Jaber S, Futier E, Chiaranda M, Pelosi P. Protective mechanical ventilation during general anesthesia for open abdominal surgery improves postoperative pulmonary function. Anesthesiology. 2013;118:1307–21.CrossRefPubMed Severgnini P, Selmo G, Lanza C, Chiesa A, Frigerio A, Bacuzzi A, Dionigi G, Novario R, Gregoretti C, de Abreu MG, Schultz MJ, Jaber S, Futier E, Chiaranda M, Pelosi P. Protective mechanical ventilation during general anesthesia for open abdominal surgery improves postoperative pulmonary function. Anesthesiology. 2013;118:1307–21.CrossRefPubMed
24.
go back to reference 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. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013;369:428–37.CrossRefPubMed 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. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013;369:428–37.CrossRefPubMed
25.
go back to reference 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;308(16):1651–9.CrossRefPubMed 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;308(16):1651–9.CrossRefPubMed
26.
go back to reference Yang D, Grant MC, Stone A, Wu CL, Wick EC. A meta-analysis of intraoperative ventilation strategies to prevent pulmonary complications: is low tidal volume alone sufficient to protect healthy lungs? Ann Surg. 2016;263(5):881–7.CrossRefPubMed Yang D, Grant MC, Stone A, Wu CL, Wick EC. A meta-analysis of intraoperative ventilation strategies to prevent pulmonary complications: is low tidal volume alone sufficient to protect healthy lungs? Ann Surg. 2016;263(5):881–7.CrossRefPubMed
27.
go back to reference Guay J, Ochroch EA. Intraoperative use of low volume ventilation to decrease postoperative mortality, mechanical ventilation, lengths of stay and lung injury in patients without acute lung injury. Cochrane Database Syst Rev. 2015;Dec 7(12):CD011151. Guay J, Ochroch EA. Intraoperative use of low volume ventilation to decrease postoperative mortality, mechanical ventilation, lengths of stay and lung injury in patients without acute lung injury. Cochrane Database Syst Rev. 2015;Dec 7(12):CD011151.
28.
go back to reference Boone MD, Jinadasa SP, Mueller A, Shaefi S, Kasper EM, Hanafy KA, O’Gara BP, Talmor DS. The effect of positive end-expiratory pressure on intracranial pressure and cerebral hemodynamics. Neurocrit Care. 2017;26(2):174–81.CrossRefPubMed Boone MD, Jinadasa SP, Mueller A, Shaefi S, Kasper EM, Hanafy KA, O’Gara BP, Talmor DS. The effect of positive end-expiratory pressure on intracranial pressure and cerebral hemodynamics. Neurocrit Care. 2017;26(2):174–81.CrossRefPubMed
29.
go back to reference Huynh T, Messer M, Sing RF, Miles W, Jacobs DG, Thomason MH. Positive end-expiratory pressure alters intracranial and cerebral perfusion pressure in severe traumatic brain injury. J Trauma. 2002;53:488–92.CrossRefPubMed Huynh T, Messer M, Sing RF, Miles W, Jacobs DG, Thomason MH. Positive end-expiratory pressure alters intracranial and cerebral perfusion pressure in severe traumatic brain injury. J Trauma. 2002;53:488–92.CrossRefPubMed
30.
go back to reference Arozullah AM, Khuri SF, Henderson WG, Daley J. Development and validation of a multifactorial risk index for predicting postoperative pneumonia after major noncardiac surgery. Ann Intern Med. 2001;135:847–57.CrossRefPubMed Arozullah AM, Khuri SF, Henderson WG, Daley J. Development and validation of a multifactorial risk index for predicting postoperative pneumonia after major noncardiac surgery. Ann Intern Med. 2001;135:847–57.CrossRefPubMed
31.
go back to reference Kroenke K, Lawrence VA, Theroux JF, Tuley MR. Operative risk in patients with severe obstructive pulmonary disease. Arch Intern Med. 1992;152:967–71.CrossRefPubMed Kroenke K, Lawrence VA, Theroux JF, Tuley MR. Operative risk in patients with severe obstructive pulmonary disease. Arch Intern Med. 1992;152:967–71.CrossRefPubMed
32.
go back to reference Sogame LC, Vidotto MC, Jardim JR, Faresin SM. Incidence and risk factors for postoperative pulmonary complications in elective intracranial surgery. J Neurosurg. 2008;109(2):222–7.CrossRefPubMed Sogame LC, Vidotto MC, Jardim JR, Faresin SM. Incidence and risk factors for postoperative pulmonary complications in elective intracranial surgery. J Neurosurg. 2008;109(2):222–7.CrossRefPubMed
33.
go back to reference Hulley SB, Cummings SR, Browner WS. Designing clinical research: an epidemiologic approach. 4th ed. Philadelphia: Lippincott Williams & Wilkins; 2013. p. 75. Hulley SB, Cummings SR, Browner WS. Designing clinical research: an epidemiologic approach. 4th ed. Philadelphia: Lippincott Williams & Wilkins; 2013. p. 75.
34.
go back to reference Fleiss JL, Tytun A, Ury HK. A simple approximation for calculating sample sizes for comparing independent proportions. Biometrics. 1980;36:343–6.CrossRefPubMed Fleiss JL, Tytun A, Ury HK. A simple approximation for calculating sample sizes for comparing independent proportions. Biometrics. 1980;36:343–6.CrossRefPubMed
35.
go back to reference Qaseem A, Snow V, Fitterman N, Hornbake ER, Lawrence VA, Smetana GW, Weiss K, Owens DK, Aronson M, Barry P, Casey Jr DE, Cross Jr JT, Fitterman N, Sherif KD, Weiss KB. Risk assessment for and strategies to reduce perioperative pulmonary complications for patients undergoing noncardiothoracic surgery: a guideline from the American College of Physicians. Ann Intern Med. 2006;144(8):575–80.CrossRefPubMed Qaseem A, Snow V, Fitterman N, Hornbake ER, Lawrence VA, Smetana GW, Weiss K, Owens DK, Aronson M, Barry P, Casey Jr DE, Cross Jr JT, Fitterman N, Sherif KD, Weiss KB. Risk assessment for and strategies to reduce perioperative pulmonary complications for patients undergoing noncardiothoracic surgery: a guideline from the American College of Physicians. Ann Intern Med. 2006;144(8):575–80.CrossRefPubMed
36.
go back to reference De Jong MA1, Ladha KS, Melo MF, Staehr-Rye AK, Bittner EA, Kurth T, Eikermann M. Differential effects of intraoperative positive end-expiratory pressure (PEEP) on respiratory outcome in major abdominal surgery versus craniotomy. Ann Surg. 2016;264(2):362–9.CrossRefPubMedPubMedCentral De Jong MA1, Ladha KS, Melo MF, Staehr-Rye AK, Bittner EA, Kurth T, Eikermann M. Differential effects of intraoperative positive end-expiratory pressure (PEEP) on respiratory outcome in major abdominal surgery versus craniotomy. Ann Surg. 2016;264(2):362–9.CrossRefPubMedPubMedCentral
Metadata
Title
The effect of an intraoperative, lung-protective ventilation strategy in neurosurgical patients undergoing craniotomy: study protocol for a randomized controlled trial
Authors
Liyong Zhang
Wei Xiong
Yuming Peng
Wei Zhang
Ruquan Han
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2447-4

Other articles of this Issue 1/2018

Trials 1/2018 Go to the issue