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Laparoscopic NephrectomyNCT02834039

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

A study testing Tidal volume 6 ml/kgBW and Tidal volume 10 ml/kgBW in people with Laparoscopic Nephrectomy, run by Universitas Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Laparoscopic Nephrectomy
What is being tested?
Tidal volume 6 ml/kgBW and Tidal volume 10 ml/kgBW
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteIndonesia
Study dates
May 2016to 31 Mar 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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:
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Cipto Mangunkusumo Central National Hospital

    Jakarta, DKI Jakarta, 10430

Other trials in Indonesia

About this study

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

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

Read the detailed 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.

Being tested
Tidal volume 6 ml/kgBW, Tidal volume 10 ml/kgBW
Keywords
Tidal volume, renal transplant, donor, nephrectomy, ventilation, Living renal transplant donor patient
Medical subject headings
Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tidal volume 6 ml/kgBWProcedure or surgery

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

  • Tidal volume 10 ml/kgBWProcedure or surgery

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

Study groups in NCT02834039
Study groupRoleWhat they receive
Tidal volume 6 ml/kgBWActive comparatorTidal volume 6 ml/kgBW was given to patients after endotracheal tube was inserted properly
Receives: Procedure: Tidal volume 6 ml/kgBW
Tidal volume 10 ml/kgBWActive comparatorTidal volume 10 ml/kgBW was given to patients after endotracheal tube was inserted properly.
Receives: Procedure: Tidal volume 10 ml/kgBW

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tidal impedance variation regional (TIV-ROI)

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

    Measured: 2 months

  2. Global End expiratory lung impedance difference (ΔEELI-g)

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

    Measured: 2 months

  3. Regional End expiratory lung impedance difference (ΔEELI- ROI)

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

    Measured: 2 months

  4. Compliance regional (CR)

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

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2016 (estimated)
  2. Study startMay 2016
  3. Primary completion28 Feb 2017
  4. Study completion31 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02834039
Sponsor's protocol ID
IndonesiaUAnes004
Status last verified
Aug 2017
First submitted
12 Jul 2016
Last updated
18 Aug 2017
Results posted
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 23727169

  • 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.

    PubMed 12000007

  • 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.

    PubMed 23902482

  • 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.

    PubMed 12945994

  • 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.

    PubMed 21906379

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

    PubMed 19186406

  • 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.

    PubMed 10793162

  • 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.

    PubMed 21478747

  • 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.

    PubMed 14693669

  • 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.

    PubMed 21680060

  • 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.

    PubMed 16516022

  • 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.

    PubMed 19468537

Questions about this trial

What is this clinical trial studying?

A study testing Tidal volume 6 ml/kgBW and Tidal volume 10 ml/kgBW in people with Laparoscopic Nephrectomy, run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tidal impedance variation regional (TIV-ROI) (time frame: 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02834039, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2017.

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