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

Laparoscopic Nephrectomy Clinical Trial

Official title:

Comparison of Ventilation Distribution Between Tidal Volume 6ml/kgBW and 10ml/kgBW in Laparoscopic Nephrectomy Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02834039
• Other study ID #: IndonesiaUAnes004
• Status: Completed
• Phase: N/A
• First received: July 12, 2016
• Last updated: August 15, 2017
• Start date: May 2016
• Est. completion date: March 31, 2017

Study information

• Verified date: August 2017
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Approval from Ethical Committee of Faculty of Medicine University of Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study. Non-invasive blood pressure (NIBP) monitor, electrocardiogram (ECG) and pulse-oximeter was set on the subjects in the operation room. Anesthesia procedure was epidural regional block. After given premedication (midazolam 0.05 mg/kgBW and fentanyl 1-2 ug/kgBW), induced with propofol, 1-2 mg/kgbb, endotracheal tube intubation was done facilitated by atracurium 0.5 mg/kgbb. Mechanical ventilation was set up with volume control mode, (Positive End Expiratory Pressure) PEEP 5cmH2O (5 centimeters of water), O2 fraction (FiO2) 30-50%, target carbondioxide (CO2) 35-45%. Volume tidal was given according to the group (6 mL/kgBW or 10 ml/kgBW). Hemodynamic, ventilation parameter, Electrical Impedance Tomography (EIT) parameter were recorded. If desaturation happened intraoperatively will be managed by increasing FiO2 and recruitment maneuver until oxygen saturation (SpO2) >95%. Data was analyzed using Statistical Program for Social Sciences (SPSS), for numeric data using unpaired T-test or Mann-Whitney-U test, for categorical data using Chi-square or Fisher Exact Test. Significant value is p<0.05.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 31, 2017
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Laparoscopic Nephrectomy

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Central National Hospital	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (12)

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. — View Citation

Costa EL, Lima RG, Amato MB. Electrical impedance tomography. Curr Opin Crit Care. 2009 Feb;15(1):18-24. Review. — View Citation

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. — 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

Gonçalves 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. English, Portuguese. — View Citation

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. Review. Erratum in: Lancet. 2013 Jul 20;382(9888):208. — View Citation

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. — View Citation

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. Review. — View Citation

Ricard JD, Dreyfuss D, Saumon G. Ventilator-induced lung injury. Eur Respir J Suppl. 2003 Aug;42:2s-9s. Review. — View Citation

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. Review. Spanish. — View Citation

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. — View Citation

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. Epub 2003 Dec 23. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tidal impedance variation regional (TIV-ROI)	Evaluating ROI values displayed on EIT Dräger PulmoVista® 500 monitor.	2 months
Primary	Global End expiratory lung impedance difference (?EELI-g)	Global End expiratory lung impedance difference (?EELI-g) will be measured by the EIT monitor.	2 months
Primary	Regional End expiratory lung impedance difference (?EELI- ROI)	Regional End expiratory lung impedance difference (?EELI-g) will be measured by the EIT monitor.	2 months
Primary	Compliance regional (CR)	Tidal Impedance Variation value divided by atmospheric pressure above PEEP value.	2 months