Monitoring, PhysiologicNCT03688529
Analyzing the Noxious Autonomic Response During Shoulder Arthroscope Surgery
An observational study of Monitoring, Physiologic and Intraoperative Neurophysiological Monitoring, run by Taipei Veterans General Hospital, Taiwan.
Trial summary
To record the digital data from monitoring instruments (standard patient monitor) containing cardiovascular system information, and from depth-of-anesthesia monitoring modules (Bispectral index, Entropy module, Surgical Plethysmography Index, Analgesia Nociception Index) containing neurological system information… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Monitoring, Physiologic, Intraoperative Neurophysiological Monitoring, Anesthesia and Analgesia
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2018to Jan 2019
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients agree and plan to undergo elective shoulder arthroscope surgery for rotator cuff tear
Who may be able to join
- patients agree and plan to undergo elective shoulder arthroscope surgery for rotator cuff tear
Who cannot join
- major cardiac problems
- uncontrolled hypertension
- arrhythmia shown in pre-operative ECG
- major neurological disease
- vulnerable populations per institutional regulation, including under-age, history of drug abuse, HIV carrier, AIDS, aborigine, prisoner.
- anticipated difficult airways
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Using Physiological Monitoring Instruments to Measure Autonomic Response From Surgical Steps of Shoulder Arthroscopy Surgery
To record the digital data from monitoring instruments (standard patient monitor) containing cardiovascular system information, and from depth-of-anesthesia monitoring modules (Bispectral index, Entropy module, Surgical Plethysmography Index, Analgesia Nociception Index) containing neurological system information captured in the patient monitor, as well as the physiological data regarding anesthetic dosage, respiratory gas analysis and the standard monitoring requirement of anesthesia. The investigators also record the precise time points of detail surgical steps during the shoulder arthroscopic surgery. Clinical data collected from these monitoring instrument will be used to gain more understanding of the complex interaction between anesthetic effect, surgical procedure, autonomic response and drug modeling. The goal is to obtain the performance of each monitoring index in detail surgical steps.
Read the detailed description
The dynamic interaction between surgery and anesthesia is closely monitored by the anesthesiologist using various monitoring instruments in the operating room. However, it requires the recording and collecting the data for further analysis to answer the question that what is the exact effects of the surgical procedure to human body. In particular, the measurement performance of transient bradycardia calculated from electrocardiography and the monitoring indices such as Surgical Plethysmography Index, Analgesia Nociception Index should be compared side-by-side using data from the same subject.
In this prospective observational study, the investigators will enroll 40 patients undergoing elective laparoscopic surgery. Anesthetic management and surgery will be performed as usual clinical practice.
The investigators will record the digital data exported from monitoring instruments, including cardiovascular system information (electrocardiography, photo-plethysmography , blood pressure and any additional monitoring items clinically required), neurological system information (Bispectral index, Entropy, Surgical Plethysmography Index ) and the respiratory gas monitoring (gas analyzer, respiratory waveform). All above data are provided by standard patient monitor (CARESCAPE Monitor B850, GE Healthcare). Analgesia Nociception Index are provides by Analgesia Nociception Index monitoring instruments (Mdoloris Medical Systems).
The detailed surgical steps will be noted with precise time stamps to pinpoint the surgical effects afterwards. Registered events including anesthetic induction, intubation, disinfection, skin incision, dissecting muscle layer, fixing rupture site, suture to close tear site and wound closure. The recording is ended before the end of monitoring in the operating room. All physiological data and demographic data will be stored in digital media after being de-linked from personal identification.
Data analysis and Statistics will be particularly performed to explore the temporal effect and relationship. Methods including modeling, windowing and non-parametric spectral estimation will be used.
- Conditions
- Monitoring, Physiologic, Intraoperative Neurophysiological Monitoring, Anesthesia and Analgesia, Arthroscopy
- Medical subject headings
- Agnosia
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of the instantaneous effects and accumulative noxious effects of surgical steps with quantitative transient bradycardia indices: high frequency power, low frequency power, and the low-to-high ratio
Frequency power will be calculated using time-frequency analysis technique. The unit of high frequency power and low frequency power is millisecond square. There is no unit for the ratio. Both absolute change and relative change will be calculated. These indices will be compared with physiological data from patient monitoring instrument also. Range of Spearman correlation is -1 to 1 and Range of prediction probability is 0.5-1.
Measured: For each surgical events (skin incision, dissection... ), time frame will be one minute before the event to one minute afterward
Secondary outcomes (1)
Pharmacological modeling of epidemiological factors and anesthetic factors to physiological data from patient monitoring instrument
The effects of age, gender, pre-existing diseases, the effect site concentration of anesthetics and the combined effects are taken into consideration in real-life clinical anesthetic management. The collected data will be put altogether for analysis by training and verifying in a pharmacological drug surface modeling or other more advanced modeling tools, which include but not limited to "Concentration-effect curve", "Reduced Greco model", "Minto model" and "Hierarchy model".
Measured: The intra-operative period which mostly lasts less than two hours, the duration of general anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study startOct 2018 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monitoring, PhysiologicStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- Duke University
- Responsible party
- Sponsor
- Investigators
- Chien-Kun Ting, Dr., Study director, Department of Anesthesiology, Taipei Veterans General Hospital, TaiwanShen-Chih Wang, Principal investigator, Department of Anesthesiology, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03688529
- Sponsor's protocol ID
- V107C-209R
- Status last verified
- Sep 2018
- First submitted
- 26 Sep 2018
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome will be made available at Dataverse. (https://dataverse.harvard.edu/)
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Physiological Monitoring Instruments to Measure Autonomic Response From Surgical Steps of Shoulder Arthroscopy Surgery
- ClinicalTrials.gov ID
- NCT03688529
- Acronym / sponsor ID
- V107C-209R
- Conditions
- Monitoring, Physiologic, Intraoperative Neurophysiological Monitoring, Anesthesia and Analgesia, Arthroscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Collaborators
- Duke University
- Study start
- Oct 2018 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 28 Sep 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.
To record the digital data from monitoring instruments (standard patient monitor) containing cardiovascular system information, and from depth-of-anesthesia monitoring modules (Bispectral index, Entropy module, Surgical Plethysmography Index, Analgesia Nociception Index) containing neurological system information captured in the patient monitor, as well as the physiological data regarding anesthetic dosage, respiratory gas analysis and the standard monitoring requirement of anesthesia. The investigators also record the precise time points of detail surgical steps during the shoulder arthroscopic surgery. Clinical data collected from these monitoring instrument will be used to gain more understanding of the complex interaction between anesthetic effect, surgical procedure, autonomic response and drug modeling. The goal is to obtain the performance of each monitoring index in detail surgical steps.
Detailed description
The dynamic interaction between surgery and anesthesia is closely monitored by the anesthesiologist using various monitoring instruments in the operating room. However, it requires the recording and collecting the data for further analysis to answer the question that what is the exact effects of the surgical procedure to human body. In particular, the measurement performance of transient bradycardia calculated from electrocardiography and the monitoring indices such as Surgical Plethysmography Index, Analgesia Nociception Index should be compared side-by-side using data from the same subject.
In this prospective observational study, the investigators will enroll 40 patients undergoing elective laparoscopic surgery. Anesthetic management and surgery will be performed as usual clinical practice.
The investigators will record the digital data exported from monitoring instruments, including cardiovascular system information (electrocardiography, photo-plethysmography , blood pressure and any additional monitoring items clinically required), neurological system information (Bispectral index, Entropy, Surgical Plethysmography Index ) and the respiratory gas monitoring (gas analyzer, respiratory waveform). All above data are provided by standard patient monitor (CARESCAPE Monitor B850, GE Healthcare). Analgesia Nociception Index are provides by Analgesia Nociception Index monitoring instruments (Mdoloris Medical Systems).
The detailed surgical steps will be noted with precise time stamps to pinpoint the surgical effects afterwards. Registered events including anesthetic induction, intubation, disinfection, skin incision, dissecting muscle layer, fixing rupture site, suture to close tear site and wound closure. The recording is ended before the end of monitoring in the operating room. All physiological data and demographic data will be stored in digital media after being de-linked from personal identification.
Data analysis and Statistics will be particularly performed to explore the temporal effect and relationship. Methods including modeling, windowing and non-parametric spectral estimation will be used.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients agree and plan to undergo elective shoulder arthroscope surgery for rotator cuff tear
Key inclusion criteria (1 listed)
- patients agree and plan to undergo elective shoulder arthroscope surgery for rotator cuff tear
Key exclusion criteria (6 listed)
- major cardiac problems
- uncontrolled hypertension
- arrhythmia shown in pre-operative ECG
- major neurological disease
- vulnerable populations per institutional regulation, including under-age, history of drug abuse, HIV carrier, AIDS, aborigine, prisoner.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation of the instantaneous effects and accumulative noxious effects of surgical steps with quantitative transient bradycardia indices: high frequency power, low frequency power, and the low-to-high ratio
Time frame: For each surgical events (skin incision, dissection... ), time frame will be one minute before the event to one minute afterward
Frequency power will be calculated using time-frequency analysis technique. The unit of high frequency power and low frequency power is millisecond square. There is no unit for the ratio. Both absolute change and relative change will be calculated. These indices will be compared with physiological data from patient monitoring instrument also. Range of Spearman correlation is -1 to 1 and Range of prediction probability is 0.5-1.
1 secondary outcome
Pharmacological modeling of epidemiological factors and anesthetic factors to physiological data from patient monitoring instrument
Time frame: The intra-operative period which mostly lasts less than two hours, the duration of general anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome will be made available at Dataverse. (https://dataverse.harvard.edu/)
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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.
Chien-Kun Ting, Dr. study director
Department of Anesthesiology, Taipei Veterans General Hospital, Taiwan
Shen-Chih Wang principal investigator
Department of Anesthesiology, Taipei Veterans General Hospital, Taiwan
Questions about this trial
What is this clinical trial studying?
An observational study of Monitoring, Physiologic and Intraoperative Neurophysiological Monitoring, run by Taipei Veterans General Hospital, Taiwan.
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 6 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 28 Sep 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 Kuang-Yi Chang, Dr. (0938593159, sufentanil@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of the instantaneous effects and accumulative noxious effects of surgical steps with quantitative transient bradycardia indices: high frequency power, low frequency power, and the low-to-high ratio (time frame: For each surgical events (skin incision, dissection... ), time frame will be one minute before the event to one minute afterward). 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 28 Sep 2018.