Manual vs Closed-loop Control of Mean Arterial Pressure
কীওয়ার্ডস
বিমূর্ত
বর্ণনা
In order to prevent the known postoperative complications of intraoperative hypotension, vasopressor agents are occasionally used to ensure adequate perfusion. These vasopressors are usually administered as manually adjusted infusions, but this practice requires considerable time and attention.
To overcome this issue, the investigators have developed a closed-loop vasopressor (CLV) controller to potentially correct hypotension more efficiently. After completing extensive in-silico, in-vivo studies and a pilot human trial in a small cohort of 20 patients, the investigators aimed to conduct now a randomized control trial comparing manual vasopressor adjustment versus closed-loop vasopressor adjustment in high risk patients undergoing major abdominal surgeries in order to correct hypotension during surgery
The primary outcome will be the incidence of hypotension (defined as a reduction of > 10% from patient's MAP target, or a allowed tolerance of 10% reduction from patient's baseline MAP). This has been chosen based on the recent study of Emmanuel Futier and colleagues (Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1346-1357), even if it was originally done with systolic blood pressure
Participants in both groups will receive standard patient care in that in no way will their anesthetic or surgical procedure will be altered as part of the study, with the exception of vasopressor administration.
Fluids will be standardized in both groups and will be given as a continuous baseline infusion of 3 ml/kg/h (balanced crystalloid solution) and additional fluid boluses (mini fluid challenges of 100 ml) as a goal directed fluid therapy strategy to maintain stroke volume variation < 13%. The only difference is the way norepinephrine is delivered to the patient (manual versus closed-loop assisted)
তারিখ
সর্বশেষ যাচাই করা হয়েছে: | 02/29/2020 |
প্রথম জমা দেওয়া: | 09/11/2019 |
আনুমানিক তালিকাভুক্তি জমা দেওয়া হয়েছে: | 09/11/2019 |
প্রথম পোস্ট: | 09/12/2019 |
সর্বশেষ আপডেট জমা দেওয়া হয়েছে: | 03/05/2020 |
সর্বশেষ আপডেট পোস্ট: | 03/09/2020 |
আসল অধ্যয়ন শুরুর তারিখ: | 09/16/2019 |
আনুমানিক প্রাথমিক সমাপ্তির তারিখ: | 03/04/2020 |
আনুমানিক অধ্যয়ন সমাপ্তির তারিখ: | 03/04/2020 |
অবস্থা বা রোগ
হস্তক্ষেপ / চিকিত্সা
Device: closed-loop group
Device: manual group
পর্যায়
বাহু গ্রুপ
বাহু | হস্তক্ষেপ / চিকিত্সা |
---|---|
Active Comparator: manual group Hypotension will be corrected by manual infusion of norepinephrine | Device: manual group Vasopressor agents will be manually adjusted (standard practice).
Fluids will be given using a goal directed strategy (EV1000 Monitor, Edwards Lifesciences, Irvine, CA, USA) |
Experimental: closed-loop group Hypotension will be corrected by closed-loop control of norepinephrine infusion | Device: closed-loop group Hypotension will be corrected by an automated system for vasopressor administration.
Fluids will be given using a goal directed strategy (EV1000 Monitor, Edwards Lifesciences, Irvine, CA, USA) |
যোগ্যতার মানদণ্ড
বয়স অধ্যয়নের জন্য যোগ্য | 18 Years প্রতি 18 Years |
লিঙ্গ অধ্যয়নের জন্য যোগ্য | All |
স্বাস্থ্যকর স্বেচ্ছাসেবীদের গ্রহণ করে | হ্যাঁ |
নির্ণায়ক | Inclusion Criteria: - High-risk adult patients undergoing major abdominal surgeries requiring an advanced cardiac output monitoring device (EV1000-Edwards LifeSciences, Irvine, USA) and a tight blood pressure control Exclusion Criteria: - Atrial Fibrillation - Severe Arythmia |
ফলাফল
প্রাথমিক ফলাফল ব্যবস্থা
1. Percentage of case Time in hypotension (MAP < 90% of the chosen MAP target). [At postoperative day 1]
মাধ্যমিক ফলাফলের ব্যবস্থা
1. Percentage of case time in hypotension (MAP < 65 mmHg) [during surgery]
2. Percentage of case time in target (MAP +/- 10 mmHg) of the chosen MAP target [during surgery]
3. Amount of vasopressors received [during surgery]
4. Uretral perfusion index during surgery [during surgery]
5. Uretral perfusion index during the first 15 minutes of the surgery [during surgery]
6. Uretral perfusion index during the last 15 minutes of the surgery [during surgery]
7. Cardiac index during surgery [during surgery]
8. Stroke volume index during surgery [during surgery]
9. Stroke volume variation during surgery [during surgery]
10. Amount of fluid received during surgery [during surgery]
11. Net fluid balance during surgery [during surgery]