Ventilation Perfusion MismatchNCT03508791
Effect of Patient Position on Arterial, End-tidal and Transcutaneous Carbon Dioxide
A study testing Arterial carbon dioxide monitoring, End-tidal carbon dioxide monitoring and Transcutaneous carbon dioxide monitoring in people with Ventilation Perfusion Mismatch, run by SMG-SNU Boramae Medical Center.
Trial summary
Investigators evaluate the effect of patient position (Trendelenburg and reverse Trendelenburg) on arterial, end-tidal and transcutaneous carbon dioxide partial pressure in patients undergoing laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Ventilation Perfusion Mismatch
- What is being tested?
- Arterial carbon dioxide monitoring, End-tidal carbon dioxide monitoring and Transcutaneous carbon dioxide monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2018to Apr 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients undergoing laparoscopic surgery (expected duration of pneumoperitoneum > 1 hour) in the Trendelenburg or reverse Trendelenburg positions
Who cannot join
- hemodynamically unstable patients due to decompensated heart failure, sepsis, or symptomatic arrhythmia, etc.
- symptomatic pulmonary disease, chronic obstructive pulmonary disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Patient Position on Arterial, End-tidal and Transcutaneous Carbon Dioxide Partial Pressure in Patients Undergoing Laparoscopic Surgery
Investigators evaluate the effect of patient position (Trendelenburg and reverse Trendelenburg) on arterial, end-tidal and transcutaneous carbon dioxide partial pressure in patients undergoing laparoscopic surgery.
Read the detailed description
Investigators evaluate the effect of patient position (Trendelenburg and reverse Trendelenburg) on arterial, end-tidal and transcutaneous carbon dioxide partial pressure in patients undergoing laparoscopic surgery. Arterial carbon dioxide partial pressure is assessed intermittently before, during, and after pneumoperitoneum. End-tidal and transcutaneous carbon dioxide partial pressure are continuously monitored.
- Conditions
- Ventilation Perfusion Mismatch
- Being tested
- Arterial carbon dioxide monitoring, End-tidal carbon dioxide monitoring, Transcutaneous carbon dioxide monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial carbon dioxide monitoringOther
Arterial carbon dioxide partial pressure is monitored during the laparoscopic surgery undergoing in the Trendelenburg or reverse Trendelenburg positions.
End-tidal carbon dioxide monitoringOther
End-tidal carbon dioxide partial pressure is monitored during the laparoscopic surgery undergoing in the Trendelenburg or reverse Trendelenburg positions.
Transcutaneous carbon dioxide monitoringOther
Transcutaneous carbon dioxide partial pressure is monitored during the laparoscopic surgery undergoing in the Trendelenburg or reverse Trendelenburg positions.
| Study group | Role | What they receive |
|---|---|---|
| Trendelenburg group | Active comparator | Arterial, end-tidal, and transcutaneous carbon dioxide partial pressure are monitored in the Trendelenberg position Receives: Other: Arterial carbon dioxide monitoring; Other: End-tidal carbon dioxide monitoring; Other: Transcutaneous carbon dioxide monitoring |
| reverse Trendelenburg group | Active comparator | Arterial, end-tidal, and transcutaneous carbon dioxide partial pressure are monitored in the reverse Trendelenberg position Receives: Other: Arterial carbon dioxide monitoring; Other: End-tidal carbon dioxide monitoring; Other: Transcutaneous carbon dioxide monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between arterial and end-tidal carbon dioxide pressures
Difference between arterial and end-tidal carbon dioxide partial pressures are calculated. (Arterial carbon dioxide partial pressure minus end-tidal carbon dioxide partial pressure)
Measured: baseline before CO2 pneumoperitoneum, every 30 minute during CO2 pneumoperitoneum, and 15 min after deflation of CO2
Secondary outcomes (1)
Agreement among arterial, end-tidal, and transcutaneous carbon dioxide partial pressure
Arterial, end-tidal, and transcutaneous carbon dioxide partial pressures are recorded and the agreement among the values is analyzed using the statistical test.
Measured: baseline before CO2 pneumoperitoneum, every 30 minute during CO2 pneumoperitoneum, and 15 min after deflation of CO2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start20 May 2018 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilation Perfusion MismatchStudies of the same condition, open and under way.
- 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
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SMG-SNU Boramae Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Young Hwang, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508791
- Sponsor's protocol ID
- 201804-1
- Status last verified
- Apr 2018
- First submitted
- 20 Apr 2018
- Last updated
- 1 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Patient Position on Arterial, End-tidal and Transcutaneous Carbon Dioxide Partial Pressure in Patients Undergoing Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT03508791
- Acronym / sponsor ID
- 201804-1
- Conditions
- Ventilation Perfusion Mismatch
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- SMG-SNU Boramae Medical CenterUniversity, hospital or other
- Study start
- 20 May 2018 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 26 Apr 2018 (actual)
- 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.
Investigators evaluate the effect of patient position (Trendelenburg and reverse Trendelenburg) on arterial, end-tidal and transcutaneous carbon dioxide partial pressure in patients undergoing laparoscopic surgery.
Detailed description
Investigators evaluate the effect of patient position (Trendelenburg and reverse Trendelenburg) on arterial, end-tidal and transcutaneous carbon dioxide partial pressure in patients undergoing laparoscopic surgery. Arterial carbon dioxide partial pressure is assessed intermittently before, during, and after pneumoperitoneum. End-tidal and transcutaneous carbon dioxide partial pressure are continuously monitored.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trendelenburg group | Active comparator | Other: Arterial carbon dioxide monitoring, Other: End-tidal carbon dioxide monitoring, Other: Transcutaneous carbon dioxide monitoringArterial, end-tidal, and transcutaneous carbon dioxide partial pressure are monitored in the Trendelenberg position |
| reverse Trendelenburg group | Active comparator | Other: Arterial carbon dioxide monitoring, Other: End-tidal carbon dioxide monitoring, Other: Transcutaneous carbon dioxide monitoringArterial, end-tidal, and transcutaneous carbon dioxide partial pressure are monitored in the reverse Trendelenberg position |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients undergoing laparoscopic surgery (expected duration of pneumoperitoneum > 1 hour) in the Trendelenburg or reverse Trendelenburg positions
Key exclusion criteria (2 listed)
- hemodynamically unstable patients due to decompensated heart failure, sepsis, or symptomatic arrhythmia, etc.
- symptomatic pulmonary disease, chronic obstructive pulmonary disease
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 |
|---|---|---|
| Arterial carbon dioxide monitoringArterial carbon dioxide partial pressure is monitored during the laparoscopic surgery undergoing in the Trendelenburg or reverse Trendelenburg positions. | Other | Trendelenburg group, reverse Trendelenburg group |
| End-tidal carbon dioxide monitoringEnd-tidal carbon dioxide partial pressure is monitored during the laparoscopic surgery undergoing in the Trendelenburg or reverse Trendelenburg positions. | Other | Trendelenburg group, reverse Trendelenburg group |
| Transcutaneous carbon dioxide monitoringTranscutaneous carbon dioxide partial pressure is monitored during the laparoscopic surgery undergoing in the Trendelenburg or reverse Trendelenburg positions. | Other | Trendelenburg group, reverse Trendelenburg group |
Primary outcome
Difference between arterial and end-tidal carbon dioxide pressures
Time frame: baseline before CO2 pneumoperitoneum, every 30 minute during CO2 pneumoperitoneum, and 15 min after deflation of CO2
Difference between arterial and end-tidal carbon dioxide partial pressures are calculated. (Arterial carbon dioxide partial pressure minus end-tidal carbon dioxide partial pressure)
1 secondary outcome
Agreement among arterial, end-tidal, and transcutaneous carbon dioxide partial pressure
Time frame: baseline before CO2 pneumoperitoneum, every 30 minute during CO2 pneumoperitoneum, and 15 min after deflation of CO2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Arterial carbon dioxide monitoring, End-tidal carbon dioxide monitoring and Transcutaneous carbon dioxide monitoring in people with Ventilation Perfusion Mismatch, run by SMG-SNU Boramae Medical Center.
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: status not confirmed, as of the sponsor's last update on 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin-Young Hwang, MD.Ph.D. (82-2-870-2518, mistyblue15@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between arterial and end-tidal carbon dioxide pressures (time frame: baseline before CO2 pneumoperitoneum, every 30 minute during CO2 pneumoperitoneum, and 15 min after deflation of CO2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2018.