CClinicalTrials.gg
Status unknownNCT03740854Updated Feb 27, 2019

The Effects of Two Different Ventilation Strategies on Lung Ventilation: An Ultrasonographic Evaluation.

An interventional study of Pressure Controlled Ventilation and Volume Controlled Ventilation in Prostate Cancer, sponsored by Istanbul University. Status unknown at 1 site in Turkey. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-02-27.

Sponsored by Istanbul University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Male
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Study summary

This study will be performed in robotic assisted laparoscopic radical prostatectomy patients in Cerrahpasa Medical Faculty Monoblock Operating Room. Since robot-assisted laparoscopic radical prostatectomy is a surgical procedure which requires long-term mechanical ventilation, excessive trendelenburg position (30-45 °) and pneumoperitoneum; these interventions may lead to respiratory complications such as ventilation difficulty and aeration loss in patients. Nowadays, lung ultrasonography has been used in anesthesia practice and intensive care units in order to determine lung aeration loss. In this study, the investigators aimed to compare the possible aeration loss in lung parenchyma during pressure controlled ventilation and volume controlled ventilation which are frequently used in anesthesia practice in patients undergoing robotic radical prostatectomy.

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Conditions studied

  • Prostate Cancer

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Keywords

  • lung ultrasonography
  • mechanical ventilation
  • pressure controlled ventilation
  • volume controlled ventilation
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In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 72 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Istanbul University is the lead sponsor of 496 studies on the registry; 79 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria: 18-75 age

  • Patient who will be undergo robot assisted laparoscopic prostatectomy surgery
  • Patient with ASA (American Society of Anesthesiologists) Score 1-3

Exclusion Criteria:

  • Patients with ASA Score above 3
  • Patients with obstructive (FEV1\<%60) or restrictive pulmonary disease (FVC\<%60)
  • Patients with intrathoracic operation history
  • Heavy smokers (>25 cigarettes/day)
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
72 participants (estimated)

Study arms

  • Active comparator
    Pressure Controlled Ventilation

    Patients undergoing pressure controlled ventilation

    Other: Pressure Controlled Ventilation

  • Active comparator
    Volume Controlled Ventilation

    Patients undergoing volume controlled ventilation

    Other: Volume Controlled Ventilation

Interventions

  • OtherPressure Controlled Ventilation

    Patients will be ventilated with a pressure level which supplies a tidal volume corresponding 8ml/kg, 12 breaths per minute, 1/2 inspiration/expiration ratio and %40 Fraction of Inspired Oxygen . These ventilator settings can be changed in order to adjust end tidal carbon dioxide and oxygen saturation levels.

  • OtherVolume Controlled Ventilation

    Patients will be ventilated with a tidal volume which corresponds 8ml/kg, 12 breaths per minute, 1/2 inspirastion/expiration ratio and %40 Fraction of Inspired Oxygen . These ventilator settings can be changed in order to adjust end tidal carbon dioxide and oxygen saturation levels.

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What researchers measure

Primary outcomes

  1. The difference between LUS Scores at T5 in patients ventilated with VCV and PCV

    Lung Ultrasonography will be applied to patients after surgery in the recovery room at T5. Two different groups' LUS scores will be calculated and compared.

    Time frame: (T5) 60 minutes after patients come to the recovery room.

Secondary outcomes

  1. The difference between LUS Scores at T2 in patients ventilated with VCV and PCV

    Lung Ultrasonography will be applied to patients after intubation. Two different groups' LUS scores will be calculated and compared.

    Time frame: (T2) 5 minutes after intubation

  2. The difference between LUS Scores at T3 in patients ventilated with VCV and PCV

    Lung Ultrasonography will be applied to patients at Trendelenburg position after the surgical prosedure is finished. Two different groups' LUS scores will be calculated and compared.

    Time frame: (T3) 5 minutes after the surgical procedure is finished

  3. The difference between LUS Scores at T4 in patients ventilated with VCV and PCV

    Lung Ultrasonography will be applied to patients at supin position after the surgical prosedure is finished. Two different groups' LUS scores will be calculated and compared.

    Time frame: (T4) 5 minutes after taking the patient to supin position

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03740854
Lead sponsor
Istanbul University
Responsible party
Hacer Zeynep Turgut (MD, Istanbul University) — Principal investigator
First posted
Nov 14, 2018
Start date
Dec 4, 2018
Primary completion
Nov 1, 2019 (estimated)
Completion
Jul 1, 2020 (estimated)
Last update
Feb 27, 2019

Study contacts

Hacer Zeynep Turgut, MD
Contact
drzturgut@gmail.com
+905057859922
Fatis Altintas, MD
Contact
fatisaltintas@hotmail.com
+905337785278
Fatis Altintas, MD
study director · Istanbul Unıversity-Cerrahpasa, Cerrahpasa Medical Faculty

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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