Abdominal CancerWARDNCT03102619
Wireless Assessment of Respiratory and Circulatory Distress; A Pilot Study
An observational study of Abdominal Cancer and Postoperative Complications, run by Bispebjerg Hospital at 2 sites in Denmark.
Trial summary
Postoperative observation of patients is based on the Early Warning Score (EWS). By using continuous wireless monitoring of vital parameters it may be possible to predict the risk of complications after abdominal cancer surgery. The object of this pilot study is to test the equipment and methods for the next phases. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Abdominal Cancer, Postoperative Complications, Respiratory Complication
- How many people
- 50 participants
- Where
- 2 sitesDenmark
- Study dates
- 23 Mar 2017to 1 Jul 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients undergoing major abdominal cancer surgery with a curative intention at either Bispebjerg Hospital or Rigshospitalet.
Who may be able to join
- Diagnosis of cancer of either esophagus, stomach, pancreas, liver, colon or rectum.
- Elective surgery with curative intention at Bispebjerg Hospital or Rigshospitalet in Copenhagen, Denmark.
- Estimated duration of surgery > 2 hours
- > 65 years
- Preoperative ECG showing sinus rhythm
- No treatment limitations
- Fit to receive optimized care according to the regimens on the given wards
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Rigshospitalet
Copenhagen, 2100
Bispebjerg Hospital
Copenhagen, 2400
About this study
Postoperative observation of patients is based on the Early Warning Score (EWS). By using continuous wireless monitoring of vital parameters it may be possible to predict the risk of complications after abdominal cancer surgery. The object of this pilot study is to test the equipment and methods for the next phases. Patients will be monitored for 4 days postoperatively and data is analyzed retrospectively. Vital parameters are monitored with ECG, blood pressure monitor and pulseoximetry.
In the analysis the investigators will compare the results from the continuous monitoring to the measurements made by the nurses and registered in the EWS. The primary outcomes for the pilot study are the frequency of measurements resulting in a single parameter score of 3 according to the EWS algorithm.
- Conditions
- Abdominal Cancer, Postoperative Complications, Respiratory Complication, Circulatory; Complications
- Keywords
- Wireless monitoring, Postoperative complications, Vital parameters, Continuous monitoring
- Medical subject headings
- Postoperative Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate resulting in a single parameter score of 3 according to EWS algorithm
All data from the monitoring will be analyzed using the thresholds from the EWS algorithm and will be sorted into relevant categories. The following thresholds are used:
Bradycardia: pulse < 41 bpm Tachycardia: pulse > 130 bpm
Measured: The patients are monitored for 4 days
Respiration rate resulting in a single parameter score of 3 according to EWS algorithm
Bradypnea: < 9 breaths/min Tachypnea: > 24 breaths/min
Measured: The patients are monitored for 4 days
Blood pressure resulting in a single parameter score of 3 according to EWS algorithm
Hypotension: Systolic blood pressure < 91 mmHg Hypertension: Systolic blood pressure > 219 mmHg
Measured: The patients are monitored for 4 days
Blood oxygen saturation resulting in a single parameter score of 3 according to EWS algorithm
Hypoxemia: arterial oxygen saturation < 92 %
Measured: The patients are monitored for 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start23 Mar 2017
- Primary completion1 Jul 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal CancerStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Technical University of Denmark
- Responsible party
- Principal investigator, Camilla Lundgreen Duus, Bispebjerg Hospital
- Investigators
- Christian S Meyhoff, MD, PhD, Study chair, Bispebjerg HospitalEske K Aasvang, MD, DMSci, Study chair, Copenhagen University Hospital, RigshospitaletHelge B Dissing, PhD, Study chair, Technical University of DenmarkCamilla L Duus, MB, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102619
- Sponsor's protocol ID
- Bispebjerg Hospital
- Acronym
- WARD
- Status last verified
- Jan 2018
- First submitted
- 24 Mar 2017
- Last updated
- 18 Jan 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 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wireless Assessment of Respiratory and Circulatory Distress; A Pilot Study
- ClinicalTrials.gov ID
- NCT03102619
- Acronym / sponsor ID
- WARD / Bispebjerg Hospital
- Conditions
- Abdominal Cancer, Postoperative Complications, Respiratory Complication, Circulatory; Complications
- Keywords
- Wireless monitoring, Postoperative complications, Vital parameters, Continuous monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Technical University of Denmark
- Study start
- 23 Mar 2017 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 6 Apr 2017 (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.
Postoperative observation of patients is based on the Early Warning Score (EWS). By using continuous wireless monitoring of vital parameters it may be possible to predict the risk of complications after abdominal cancer surgery. The object of this pilot study is to test the equipment and methods for the next phases. Patients will be monitored for 4 days postoperatively and data is analyzed retrospectively. Vital parameters are monitored with ECG, blood pressure monitor and pulseoximetry.
In the analysis the investigators will compare the results from the continuous monitoring to the measurements made by the nurses and registered in the EWS. The primary outcomes for the pilot study are the frequency of measurements resulting in a single parameter score of 3 according to the EWS algorithm.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients undergoing major abdominal cancer surgery with a curative intention at either Bispebjerg Hospital or Rigshospitalet.
Key inclusion criteria (7 listed)
- Diagnosis of cancer of either esophagus, stomach, pancreas, liver, colon or rectum.
- Elective surgery with curative intention at Bispebjerg Hospital or Rigshospitalet in Copenhagen, Denmark.
- Estimated duration of surgery > 2 hours
- > 65 years
- Preoperative ECG showing sinus rhythm
Key exclusion criteria (0 listed)
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
Heart rate resulting in a single parameter score of 3 according to EWS algorithm
Time frame: The patients are monitored for 4 days
All data from the monitoring will be analyzed using the thresholds from the EWS algorithm and will be sorted into relevant categories. The following thresholds are used: Bradycardia: pulse < 41 bpm Tachycardia: pulse > 130 bpm
Respiration rate resulting in a single parameter score of 3 according to EWS algorithm
Time frame: The patients are monitored for 4 days
Bradypnea: < 9 breaths/min Tachypnea: > 24 breaths/min
Blood pressure resulting in a single parameter score of 3 according to EWS algorithm
Time frame: The patients are monitored for 4 days
Hypotension: Systolic blood pressure < 91 mmHg Hypertension: Systolic blood pressure > 219 mmHg
Blood oxygen saturation resulting in a single parameter score of 3 according to EWS algorithm
Time frame: The patients are monitored for 4 days
Hypoxemia: arterial oxygen saturation < 92 %
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 18 Jan 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.
Christian S Meyhoff, MD, PhD study chair
Bispebjerg Hospital
Eske K Aasvang, MD, DMSci study chair
Copenhagen University Hospital, Rigshospitalet
Helge B Dissing, PhD study chair
Technical University of Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Cancer and Postoperative Complications, run by Bispebjerg Hospital at 2 sites in Denmark.
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 7 inclusion and 0 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 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Heart rate resulting in a single parameter score of 3 according to EWS algorithm (time frame: The patients are monitored for 4 days). The study lists 4 primary outcomes in all. 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 18 Jan 2018.