General Anesthesia Using Endotracheal IntubationNCT01892449
Comparison of Different Inspiratory to Expiratory Ratios on Respiratory Mechanics and Oxygenation in Robot-assisted Laparoscopic Radical Prostatectomy With Steep Trendelenburg Position and Pneumoperitoneum
A study testing prolonged inspiratory to expiratory (I:E) ratio (1:1) and conventional I:E ratio (1:2) in people with General Anesthesia Using Endotracheal Intubation, run by Yonsei University at 1 site in South Korea.
Trial summary
The steep trendelenburg position and pneumoperitoneum during laparoscopic surgery have the potential to cause an adverse effects on respiratory mechanics and gas exchange. Previous studies have proposed that a prolonged I:E ratio ventilation improved respiratory mechanics and gas exchange. Read more about this study
- Who is it for?
- Ages 20 to 90 years, men only
- Conditions the study is for
- General Anesthesia Using Endotracheal Intubation
- What is being tested?
- prolonged inspiratory to expiratory (I:E) ratio (1:1) and conventional I:E ratio (1:2)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2013to Feb 2014
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male patients (20-90 years of age) scheduled for elective robot-assisted laparoscopic radical prostatectomy undergoing general anesthesia
Who cannot join
- Patients with an abnormal airway anatomy, reactive airway diseases, chronic respiratory diseases, a history of coronary artery diseases, or heart failure
- BMI > 30 kg/m 2
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei University
Seoul, 120-752
About this study
The steep trendelenburg position and pneumoperitoneum during laparoscopic surgery have the potential to cause an adverse effects on respiratory mechanics and gas exchange. Previous studies have proposed that a prolonged I:E ratio ventilation improved respiratory mechanics and gas exchange. Therefore, the aim of this study is to evaluate whether a prolonged I:E ratio ventilation improves gas exchange and respiratory mechanics in patients undergoing robot-assisted laparoscopic radical prostatectomy.
- Being tested
- prolonged inspiratory to expiratory (I:E) ratio (1:1), conventional I:E ratio (1:2)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prolonged inspiratory to expiratory (I:E) ratio (1:1)Other
80 patients are randomly allocated into two groups : prolonged I:E ratio (1:1) (n=40) and conventional I:E ratio (1:2) group (n=40). In the prolonged I:E ratio (1:1), mechanical ventilation is maintained with during I:E ratio 1:1 during steep trendelenburg with pneumoperitoneum.
conventional I:E ratio (1:2)Other
80 patients are randomly allocated into two groups : prolonged I:E ratio (1:1) (n=40) and conventional I:E ratio (1:2) group (n=40). In the conventional I:E ratio (1:2) group (n=40), mechanical ventilation is maintained with during I:E ratio 1:2 during steep trendelenburg with pneumoperitoneum.
| Study group | Role | What they receive |
|---|---|---|
| prolonged I:E ratio (1:1) group | Experimental | Not described Receives: Other: prolonged inspiratory to expiratory (I:E) ratio (1:1) |
| conventional I:E ratio (1:2) group | Active comparator | Not described Receives: Other: conventional I:E ratio (1:2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The peak inspiratory pressure
The peak inspiratory pressure during mechanical ventilation with endotracheal intubation under general anesthesia
Measured: before 10 minutes after anesthesia induction, 30 and 60 minutes after steep trendelenburg position and pneumoperitoneum, and 10 minutes after supine position and CO2 desufflation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for General Anesthesia Using Endotracheal IntubationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01892449
- Sponsor's protocol ID
- 4-2013-0287
- Status last verified
- May 2014
- First submitted
- 30 Jun 2013
- Last updated
- 23 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Al-Shaikh B, George William M, Van Zundert AA. Using atmospheric pressure to inflate the cuff of the Portex Laryngeal Mask. Anaesthesia. 2005 Mar;60(3):296-7. doi: 10.1111/j.1365-2044.2005.04135.x. No abstract available.
PubMed 15710025Kim 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
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Inspiratory to Expiratory Ratios on Respiratory Mechanics and Oxygenation in Robot-assisted Laparoscopic Radical Prostatectomy With Steep Trendelenburg Position and Pneumoperitoneum
- ClinicalTrials.gov ID
- NCT01892449
- Acronym / sponsor ID
- 4-2013-0287
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 4 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The steep trendelenburg position and pneumoperitoneum during laparoscopic surgery have the potential to cause an adverse effects on respiratory mechanics and gas exchange. Previous studies have proposed that a prolonged I:E ratio ventilation improved respiratory mechanics and gas exchange. Therefore, the aim of this study is to evaluate whether a prolonged I:E ratio ventilation improves gas exchange and respiratory mechanics in patients undergoing robot-assisted laparoscopic radical prostatectomy.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prolonged I:E ratio (1:1) group | Experimental | Other: prolonged inspiratory to expiratory (I:E) ratio (1:1) |
| conventional I:E ratio (1:2) group | Active comparator | Other: conventional I:E ratio (1:2) |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult male patients (20-90 years of age) scheduled for elective robot-assisted laparoscopic radical prostatectomy undergoing general anesthesia
Key exclusion criteria (2 listed)
- Patients with an abnormal airway anatomy, reactive airway diseases, chronic respiratory diseases, a history of coronary artery diseases, or heart failure
- BMI > 30 kg/m 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prolonged inspiratory to expiratory (I:E) ratio (1:1)80 patients are randomly allocated into two groups : prolonged I:E ratio (1:1) (n=40) and conventional I:E ratio (1:2) group (n=40). In the prolonged I:E ratio (1:1), mechanical ventilation is maintained with during I:E ratio 1:1 during steep trendelenburg with pneumoperitoneum. | Other | prolonged I:E ratio (1:1) group |
| conventional I:E ratio (1:2)80 patients are randomly allocated into two groups : prolonged I:E ratio (1:1) (n=40) and conventional I:E ratio (1:2) group (n=40). In the conventional I:E ratio (1:2) group (n=40), mechanical ventilation is maintained with during I:E ratio 1:2 during steep trendelenburg with pneumoperitoneum. | Other | conventional I:E ratio (1:2) group |
Primary outcome
The peak inspiratory pressure
Time frame: before 10 minutes after anesthesia induction, 30 and 60 minutes after steep trendelenburg position and pneumoperitoneum, and 10 minutes after supine position and CO2 desufflation
The peak inspiratory pressure during mechanical ventilation with endotracheal intubation under general anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2014.
- Background: PubMed 15710025Al-Shaikh B, George William M, Van Zundert AA. Using atmospheric pressure to inflate the cuff of the Portex Laryngeal Mask. Anaesthesia. 2005 Mar;60(3):296-7. doi: 10.1111/j.1365-2044.2005.04135.x. No abstract available.
- Derived from this study: PubMed 25869025Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prolonged inspiratory to expiratory (I:E) ratio (1:1) and conventional I:E ratio (1:2) in people with General Anesthesia Using Endotracheal Intubation, run by Yonsei University 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 1 inclusion and 2 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 23 May 2014. 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?
The peak inspiratory pressure (time frame: before 10 minutes after anesthesia induction, 30 and 60 minutes after steep trendelenburg position and pneumoperitoneum, and 10 minutes after supine position and CO2 desufflation). 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 NCT01892449, which also lists 2 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 23 May 2014.