Comparison of Ventilation Distribution Between Tidal Volume 6ml/kgBW and 10ml/kgBW
NCT ID: NCT02834039
Last Updated: 2017-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2016-05-31
2017-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Tidal volume 6 ml/kgBW
Tidal volume 6 ml/kgBW was given to patients after endotracheal tube was inserted properly
Tidal volume 6 ml/kgBW
Tidal volume 6ml/kgBW was given to subjects after endotracheal tube was inserted properly.
Tidal volume 10 ml/kgBW
Tidal volume 10 ml/kgBW was given to patients after endotracheal tube was inserted properly.
Tidal volume 10 ml/kgBW
Tidal volume 10 ml/kgBW was given to subjects after endotracheal tube was inserted properly.
Interventions
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Tidal volume 6 ml/kgBW
Tidal volume 6ml/kgBW was given to subjects after endotracheal tube was inserted properly.
Tidal volume 10 ml/kgBW
Tidal volume 10 ml/kgBW was given to subjects after endotracheal tube was inserted properly.
Eligibility Criteria
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Inclusion Criteria
* Subjects with good health condition (did not suffer from cancer, diabetes mellitus, kidney diseases, cardiovascular diseases, liver diseases, hematologic disorders, HIV, hepatitis)
* Subjects had the same blood type with the renal recipients and had passed cross match test
* Subjects were willing to be renal donors.
Exclusion Criteria
* Subjects with Body Mass Index (BMI) \> 30 kg/m2
* Subjects who had mechanical ventilation 2 weeks prior to the surgery
* Subjects with congestive heart failure
* Subjects with neuromuscular diseases.
Drop out criteria:
* Subjects with intraoperative pulmonary complications not due to ventilation
* Subjects with intraoperative cardiac arrest
* Subjects with desaturation that could not be managed by FiO2 increase, PEEP or recruitment maneuver, and required tidal volume changes.
18 Years
60 Years
ALL
Yes
Sponsors
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Indonesia University
OTHER
Responsible Party
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Dita Aditianingsih
Consultant, Anesthesiologist
Principal Investigators
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Dita Aditianingsih, Consultant
Role: PRINCIPAL_INVESTIGATOR
Indonesia University
Locations
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Cipto Mangunkusumo Central National Hospital
Jakarta, DKI Jakarta, Indonesia
Countries
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References
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Jha V, Garcia-Garcia G, Iseki K, Li Z, Naicker S, Plattner B, Saran R, Wang AY, Yang CW. Chronic kidney disease: global dimension and perspectives. Lancet. 2013 Jul 20;382(9888):260-72. doi: 10.1016/S0140-6736(13)60687-X. Epub 2013 May 31.
Rizzotti L, Vassiliou M, Amygdalou A, Psarakis Ch, Rasmussen TR, Laopodis V, Behrakis P. Respiratory system mechanics during laparoscopic cholecystectomy. Respir Med. 2002 Apr;96(4):268-74. doi: 10.1053/rmed.2001.1264.
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.
Ricard JD, Dreyfuss D, Saumon G. Ventilator-induced lung injury. Eur Respir J Suppl. 2003 Aug;42:2s-9s. doi: 10.1183/09031936.03.00420103.
de Prost N, Ricard JD, Saumon G, Dreyfuss D. Ventilator-induced lung injury: historical perspectives and clinical implications. Ann Intensive Care. 2011 Jul 23;1(1):28. doi: 10.1186/2110-5820-1-28.
Costa EL, Lima RG, Amato MB. Electrical impedance tomography. Curr Opin Crit Care. 2009 Feb;15(1):18-24. doi: 10.1097/mcc.0b013e3283220e8c.
Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
Moerer O, Hahn G, Quintel M. Lung impedance measurements to monitor alveolar ventilation. Curr Opin Crit Care. 2011 Jun;17(3):260-7. doi: 10.1097/MCC.0b013e3283463c9c.
Victorino JA, Borges JB, Okamoto VN, Matos GF, Tucci MR, Caramez MP, Tanaka H, Sipmann FS, Santos DC, Barbas CS, Carvalho CR, Amato MB. Imbalances in regional lung ventilation: a validation study on electrical impedance tomography. Am J Respir Crit Care Med. 2004 Apr 1;169(7):791-800. doi: 10.1164/rccm.200301-133OC. Epub 2003 Dec 23.
Riera J, Riu PJ, Casan P, Masclans JR. [Electrical impedance tomography in acute lung injury]. Med Intensiva. 2011 Nov;35(8):509-17. doi: 10.1016/j.medin.2011.05.005. Epub 2011 Jun 15. Spanish.
Lorenzo AJ, Karsli C, Halachmi S, Dolci M, Luginbuehl I, Bissonnette B, Farhat WA. Hemodynamic and respiratory effects of pediatric urological retroperitoneal laparoscopic surgery: a prospective study. J Urol. 2006 Apr;175(4):1461-5. doi: 10.1016/S0022-5347(05)00668-3.
Goncalves LO, Cicarelli DD. Alveolar recruitment maneuver in anesthetic practice: how, when and why it may be useful. Rev Bras Anestesiol. 2005 Dec;55(6):631-8. doi: 10.1590/s0034-70942005000600006. English, Portuguese.
Other Identifiers
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IndonesiaUAnes004
Identifier Type: -
Identifier Source: org_study_id
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