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AzTrials

Prostatic NeoplasmNCT02966535

The Effect of Prolonged Inspiratory Time on Gas Exchange During Robot-assisted Laparoscopic Surgery With Steep Trendelenburg Position : A Crossover Randomized Clinical Trial

A study testing Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:2 to 1:1) and Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:1 to 1:2) in people with Prostatic Neoplasm and Urinary Bladder Neoplasm, run by Seoul National University Hospital at 1 site in South Korea.

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

Gas exchange disturbance frequently occurs in steep Trendelenburg position during robot-assisted laparoscopic prostatectomy or cystectomy. Due to increased intrathoracic pressure and absorbed carbon dioxide (CO2) gas insufflated into abdominal cavity, hypercapnia as well as hypoxia may occur. Read more about this study

Who is it for?
Ages 20 to 90 years, men onlyHealthy volunteers can take part
Conditions the study is for
Prostatic Neoplasm, Urinary Bladder Neoplasm
What is being tested?
Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:2 to 1:1) and Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:1 to 1:2)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteSouth Korea
Study dates
Nov 2016to Apr 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 20 to 90 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • American Society of Anesthesiologists physical status class I-II and scheduled for an elective robot-assisted laparoscopic radical prostatectomy or robot-assisted laparoscopic radical cystectomy
  • Patients who voluntarily decides to participate in the trial and has agreed in written informed consent

Who cannot join

  • Patients with the anatomical abnormalities of respiratory system(abnormal airway anatomy, severe scoliosis, post-pneumonectomy state), severe chronic respiratory diseases, chronic obstructive pulmonary disease (COPD), asthma, heart failure, obesity ( Body Mass Index [BMI] > 30kg/m2), severe hepatic failure or renal failure

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul, 03080

Other trials in South Korea

About this study

Gas exchange disturbance frequently occurs in steep Trendelenburg position during robot-assisted laparoscopic prostatectomy or cystectomy. Due to increased intrathoracic pressure and absorbed carbon dioxide (CO2) gas insufflated into abdominal cavity, hypercapnia as well as hypoxia may occur. Inverse ratio ventilation or prolonged inspiratory time during mechanical ventilation has been reported to be improve gas exchange in adult respiratory distress syndrome. The investigators attempt to test the hypothesis that prolonged inspiratory time may improve the gas exchange during robot-assisted laparoscopic urologic surgery.

Read the detailed description

Gas exchange disturbance frequently occurs in steep Trendelenburg position during robot-assisted laparoscopic prostatectomy or cystectomy. Due to increased intrathoracic pressure and absorbed CO2 gas insufflated into abdominal cavity, hypercapnia as well as hypoxia may occur. Inverse ratio ventilation or prolonged inspiratory time during mechanical ventilation has been reported to be improve gas exchange in adult respiratory distress syndrome. The investigators attempt to test the hypothesis that prolonged inspiratory time (I:E ratio = 1:1) may improve the gas exchange during robot-assisted laparoscopic urologic surgery.

Being tested
Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:2 to 1:1), Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:1 to 1:2)
Medical subject headings
Prostatic Neoplasms, Urinary Bladder Neoplasms

What participants receive

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

  • Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:2 to 1:1)Device

    Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:2 to 1:1)

  • Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:1 to 1:2)Device

    Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:1 to 1:2)

Study groups in NCT02966535
Study groupRoleWhat they receive
1:2, 1:1 groupExperimentalInspiratory to expiratory time ratio (I:E ratio) of 1:2 during the first one hour of laparoscopy and then switched to I:E ratio of 1:1 during the rest time of laparoscopy.
Receives: Device: Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:2 to 1:1)
1:1, 1:2 groupActive comparatorInspiratory to expiratory time ratio (I:E ratio) of 1:1 during the first one hour of laparoscopy and then switched to I:E ratio of 1:2 during the rest time of laparoscopy.
Receives: Device: Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:1 to 1:2)

What is being measured

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

  1. PaCO2 (mmHg) in the patient's arterial blood gas analysis

    PaCO2 (arterial partial pressure of carbon dioxide)

    Measured: 60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning

Secondary outcomes (16)

  1. PaCO2 (mmHg) in the patient's arterial blood gas analysis

    PaCO2 (arterial partial pressure of carbon dioxide)

    Measured: 5 minutes after anesthesia induction

  2. PaO2 (mmHg) in the patient's arterial blood gas analysis

    PaO2 (arterial partial pressure of oxygen)

    Measured: 5 minutes after anesthesia induction

  3. PaO2 (mmHg) in the patient's arterial blood gas analysis

    PaO2 (arterial partial pressure of oxygen)

    Measured: 60 minutes after anesthesia induction

  4. PaCO2 (mmHg) in the patient's arterial blood gas analysis

    PaCO2 (arterial partial pressure of carbon dioxide)

    Measured: 120 minutes after anesthesia induction

  5. PaO2 (mmHg) in the patient's arterial blood gas analysis

    PaO2 (arterial partial pressure of oxygen)

    Measured: 120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning

  6. PaCO2 (mmHg) in the patient's arterial blood gas analysis

    PaCO2 (arterial partial pressure of carbon dioxide)

    Measured: 10 min after restoration of supine position

  7. PaO2 (mmHg) in the patient's arterial blood gas analysis

    PaO2 (arterial partial pressure of oxygen)

    Measured: 10 min after restoration of supine position

  8. Respiratory compliance (Static, Dynamic)

    Static compliance = exhaled tidal volume / (plateau pressure - PEEP), Dynamic compliance = Exhaled tidal volume / (PIP - PEEP)

    Measured: 5 minutes after anesthesia induction

  9. Respiratory compliance (Static, Dynamic)

    Static compliance = exhaled tidal volume / (plateau pressure - PEEP), Dynamic compliance = Exhaled tidal volume / (PIP - PEEP)

    Measured: 60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning

  10. Respiratory compliance (Static, Dynamic)

    Static compliance = exhaled tidal volume / (plateau pressure - PEEP), Dynamic compliance = Exhaled tidal volume / (PIP - PEEP)

    Measured: 120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning

  11. oxygen index

    oxygen index calculated by PaO2/inspired oxygen fraction

    Measured: 5 minutes after anesthesia induction

  12. oxygen index

    oxygen index calculated by PaO2/inspired oxygen fraction

    Measured: 60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning

  13. oxygen index

    oxygen index calculated by PaO2/inspired oxygen fraction

    Measured: 120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning

  14. Alveolar-arterial oxygen difference

    Measured: 5 minutes after anesthesia induction

  15. Alveolar-arterial oxygen difference

    Measured: 60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning

  16. Alveolar-arterial oxygen difference

    Measured: 120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning

Timeline

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

  1. First posted17 Nov 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionFeb 2017
  4. Study completionApr 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
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02966535
Sponsor's protocol ID
1609-102-793
Status last verified
Sep 2017
First submitted
13 Nov 2016
Last updated
14 Mar 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • De Carlo F, Celestino F, Verri C, Masedu F, Liberati E, Di Stasi SM. Retropubic, laparoscopic, and robot-assisted radical prostatectomy: surgical, oncological, and functional outcomes: a systematic review. Urol Int. 2014;93(4):373-83. doi: 10.1159/000366008. Epub 2014 Sep 23.

    PubMed 25277444

  • Gainsburg DM. Anesthetic concerns for robotic-assisted laparoscopic radical prostatectomy. Minerva Anestesiol. 2012 May;78(5):596-604. Epub 2012 Mar 13.

    PubMed 22415437

  • Kim MS, Kim NY, Lee KY, Choi YD, Hong JH, Bai SJ. The impact of two different inspiratory to expiratory ratios (1:1 and 1:2) on respiratory mechanics and oxygenation during volume-controlled ventilation in robot-assisted laparoscopic radical prostatectomy: a randomized controlled trial. Can J Anaesth. 2015 Sep;62(9):979-87. doi: 10.1007/s12630-015-0383-2. Epub 2015 Apr 14.

    PubMed 25869025

Questions about this trial

What is this clinical trial studying?

A study testing Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:2 to 1:1) and Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:1 to 1:2) in people with Prostatic Neoplasm and Urinary Bladder Neoplasm, run by Seoul National University Hospital at 1 site in South Korea.

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 2 inclusion and 1 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 14 Mar 2019. 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 South Korea. 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?

PaCO2 (mmHg) in the patient's arterial blood gas analysis (time frame: 60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning). 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 NCT02966535, which also lists 3 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 14 Mar 2019.

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