Monitoring During Deliberate Hypotensive AnesthesiaPPINCT03007355
Peripheral Perfusion Index (PPI) as Monitor During Deliberate Hypotensive Anesthesia
An observational study of Monitoring During Deliberate Hypotensive Anesthesia, run by Cairo University.
Trial summary
Hypotensive anesthesia is effective in reducing the intraoperative blood loss. The risk of hypoperfusion of vital organs continues to be a concern. An adequate monitoring of tissue perfusion and oxygenation is crucial issue. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Monitoring During Deliberate Hypotensive Anesthesia
- What is being tested?
- peripheral perfusion index measurement
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2017
- Phase
- Observational
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: adult male or females, aged between 18-50 years, ASA class I ans II
Who may be able to join
- Patients, aged from 18-50 years, ASA physical status I and II, undergoing functional endoscopic sinus surgery (FESS) under deliberate hypotensive anesthesia
Who cannot join
- Patients with systemic hypertension, cardiovascular disease, cerebrovascular insufficiency, coagulation defects, renal or hepatic insufficiency, and hypersensitivity to the study drugs will be excluded from the study. Patients receiving vasoactive drugs or beta blockers will be also excluded from the study.
About this study
Official title: The Use of Peripheral Perfusion Index as a Predictor for Patient's Response to Deliberate Hypotension During Functional Endoscopic Sinus Surgery A Prospective Observational Study
Hypotensive anesthesia is effective in reducing the intraoperative blood loss. The risk of hypoperfusion of vital organs continues to be a concern. An adequate monitoring of tissue perfusion and oxygenation is crucial issue. Peripheral Perfusion Index (PPI) as a noninvasive new monitoring, can reflect the peripheral perfusion dynamics.
This study is designed to explore the behaviour and trend of PPI during nitroglycerine induced deliberate hypotensive anesthesia in adult patients undergoing functional endoscopic sinus surgery (FESS).
- Being tested
- peripheral perfusion index measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peripheral perfusion index measurementOther
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between PPI and T1
correlation of baseline values of PPI and time required to achieve target mean arterial pressure.
Measured: start of nitroglyceirn infusion till target arterial pressure is reached up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionOct 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monitoring During Deliberate Hypotensive AnesthesiaStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer Ahmed, MD, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007355
- Sponsor's protocol ID
- N 2015
- Acronym
- PPI
- Status last verified
- Dec 2018
- First submitted
- 26 Dec 2016
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Peripheral Perfusion Index as a Predictor for Patient's Response to Deliberate Hypotension During Functional Endoscopic Sinus Surgery A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03007355
- Acronym / sponsor ID
- PPI / N 2015
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Oct 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 2 Jan 2017 (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.
Hypotensive anesthesia is effective in reducing the intraoperative blood loss. The risk of hypoperfusion of vital organs continues to be a concern. An adequate monitoring of tissue perfusion and oxygenation is crucial issue. Peripheral Perfusion Index (PPI) as a noninvasive new monitoring, can reflect the peripheral perfusion dynamics.
This study is designed to explore the behaviour and trend of PPI during nitroglycerine induced deliberate hypotensive anesthesia in adult patients undergoing functional endoscopic sinus surgery (FESS).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- adult male or females, aged between 18-50 years, ASA class I ans II
Key inclusion criteria (1 listed)
- Patients, aged from 18-50 years, ASA physical status I and II, undergoing functional endoscopic sinus surgery (FESS) under deliberate hypotensive anesthesia
Key exclusion criteria (1 listed)
- Patients with systemic hypertension, cardiovascular disease, cerebrovascular insufficiency, coagulation defects, renal or hepatic insufficiency, and hypersensitivity to the study drugs will be excluded from the study. Patients receiving vasoactive drugs or beta blockers will be also excluded from the study.
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 |
|---|---|---|
| peripheral perfusion index measurement | Other | – |
Primary outcome
correlation between PPI and T1
Time frame: start of nitroglyceirn infusion till target arterial pressure is reached up to 2 hours
correlation of baseline values of PPI and time required to achieve target mean arterial pressure.
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 19 Dec 2018.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Monitoring During Deliberate Hypotensive Anesthesia, run by Cairo University.
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 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 19 Dec 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?
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?
correlation between PPI and T1 (time frame: start of nitroglyceirn infusion till target arterial pressure is reached up to 2 hours). 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 19 Dec 2018.