Comparison of Ventilation Distribution Between Tidal Volume 6ml/kgBW and 10ml/kgBW

NCT02834039 | Completed

• 1 other identifier: IndonesiaUAnes004
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the ventilation Distribution between tidal Volume 6ml/kgBW and tidal volume 10ml/kgBW in laparoscopic nephrectomy patients

Conditions

Laparoscopic Nephrectomy

Keywords

Tidal volume; renal transplant; donor; nephrectomy; ventilation; Living renal transplant donor patient

Outcome Measures

Primary Outcomes (4)

• Tidal impedance variation regional (TIV-ROI)

  Evaluating ROI values displayed on EIT Dräger PulmoVista® 500 monitor.

  2 months

• Global End expiratory lung impedance difference (ΔEELI-g)

  Global End expiratory lung impedance difference (ΔEELI-g) will be measured by the EIT monitor.

  2 months

• Regional End expiratory lung impedance difference (ΔEELI- ROI)

  Regional End expiratory lung impedance difference (ΔEELI-g) will be measured by the EIT monitor.

  2 months

• Compliance regional (CR)

  Tidal Impedance Variation value divided by atmospheric pressure above PEEP value.

  2 months

Study Arms (2)

Tidal volume 6 ml/kgBW

ACTIVE COMPARATOR

Tidal volume 6 ml/kgBW was given to patients after endotracheal tube was inserted properly

Procedure: Tidal volume 6 ml/kgBW

Tidal volume 10 ml/kgBW

ACTIVE COMPARATOR

Tidal volume 10 ml/kgBW was given to patients after endotracheal tube was inserted properly.

Procedure: Tidal volume 10 ml/kgBW

Interventions

Tidal volume 6 ml/kgBW PROCEDURE

Tidal volume 6ml/kgBW was given to subjects after endotracheal tube was inserted properly.

Tidal volume 6 ml/kgBW

Tidal volume 10 ml/kgBW PROCEDURE

Tidal volume 10 ml/kgBW was given to subjects after endotracheal tube was inserted properly.

Tidal volume 10 ml/kgBW

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects aged 18-60 years old
• 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.

You may not qualify if:

• Subjects with pulmonary diseases or PaO2 (arterial partial pressure of oxygen) /FiO2 \< 300 mmHg
• 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.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Central National Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

Location

Related Publications (12)

• 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.

  PMID: 23727169 BACKGROUND

• 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.

  PMID: 12000007 BACKGROUND

• 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.

  PMID: 23902482 BACKGROUND

• 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.

  PMID: 12945994 BACKGROUND

• 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.

  PMID: 21906379 BACKGROUND

• Costa EL, Lima RG, Amato MB. Electrical impedance tomography. Curr Opin Crit Care. 2009 Feb;15(1):18-24. doi: 10.1097/mcc.0b013e3283220e8c.

  PMID: 19186406 BACKGROUND

• 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.

  PMID: 10793162 BACKGROUND

• 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.

  PMID: 21478747 BACKGROUND

• 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.

  PMID: 14693669 BACKGROUND

• 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.

  PMID: 21680060 BACKGROUND

• 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.

  PMID: 16516022 BACKGROUND

• 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.

  PMID: 19468537 BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Tidal Volume

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Inspiratory Capacity; Vital Capacity; Total Lung Capacity; Lung Volume Measurements; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Dita Aditianingsih, Consultant

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Anesthesiologist

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: July 15, 2016
• Study Start: May 1, 2016
• Primary Completion: February 28, 2017
• Study Completion: March 31, 2017
• Last Updated: August 18, 2017

Record last verified: 2017-08

Locations

ID (1)