HypoxemiaAGEAWARENCT03944967
Postoperative Remote Monitoring of Vital Signs in Older Cardiac Surgery Patients
An observational study of Hypoxemia and Respiratory Failure, run by St. Antonius Hospital at 1 site in Netherlands.
Trial summary
A significant number of elderly patients experience a complication after cardiac surgery. This study aims to determine if postoperative remote monitoring of vital signs can be used to identify medicatie risk factors for vital sign deterioration in older cardiac surgery patients. Single center pilot study. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Hypoxemia, Respiratory Failure, Arrythmia
- How many people
- 71 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Mar 2020to 19 Dec 2021
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The study population includes 100 patients ≥70 years undergoing elective cardiac surgery.
Who may be able to join
- ≥70 years undergoing elective cardiac surgery.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
A significant number of elderly patients experience a complication after cardiac surgery. This study aims to determine if postoperative remote monitoring of vital signs can be used to identify medicatie risk factors for vital sign deterioration in older cardiac surgery patients.
- Single center pilot study.
- 100 older patients undergoing cardiac surgery.
- Continuous remote monitoring of vital signs after ICU discharge
- Main study endpoint is vital sign deterioration.
Read the detailed description
Cardiac surgery in elderly patients aims to improve functional capacity and overall survival but may also precipitate major morbidity and mortality. Despite major improvements in the safety of anesthesia and surgery a significant number of elderly patients experience a complication after cardiac surgery.
To determine if postoperative remote monitoring of vital signs can be used to identify medication risk factors for vital sign deterioration in older cardiac surgery patients..
- Single center pilot study.
- 100 older patients undergoing cardiac surgery.
- Continuous remote monitoring of vital signs starts after ICU discharge
- PR, RR and SpO2 will be continuously monitored in all patients.
- Patients and healthcare personnel are blinded for monitoring results.
- Main study endpoint is vital sign deterioration.
The study population includes 100 patients ≥70 years undergoing elective cardiac surgery.
- Conditions
- Hypoxemia, Respiratory Failure, Arrythmia
- Medical subject headings
- Hypoxia, Respiratory Insufficiency, Arrhythmias, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoxemia
Duration of sPO2 <80%, <85%, <90% and <95% in minutes per hour
Measured: Three consecutive days after ICU discharge
Respiratory deterioration
Duration of respiratory rate <10 min-1, >20 min-1, >25 min-1, >30 min-1 in minutes per hour
Measured: Three consecutive days after ICU discharge
Arrythmia
Duration of pulse rate <50 min-1, >100 min-1, >110 min-1, >120 min-1 in minutes per hour
Measured: Three consecutive days after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start5 Mar 2020
- Primary completion19 Dec 2021
- Study completion19 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxemiaStudies 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
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. P. Noordzij, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03944967
- Sponsor's protocol ID
- NL68944.100.19
- Acronym
- AGEAWARE
- Status last verified
- Nov 2023
- First submitted
- 22 Apr 2019
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Remote Monitoring of Vital Signs in Older Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT03944967
- Acronym / sponsor ID
- AGEAWARE / NL68944.100.19
- Conditions
- Hypoxemia, Respiratory Failure, Arrythmia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 19 Dec 2021 (actual)
- Study completion
- 19 Dec 2021 (actual)
- First posted
- 10 May 2019 (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.
A significant number of elderly patients experience a complication after cardiac surgery. This study aims to determine if postoperative remote monitoring of vital signs can be used to identify medicatie risk factors for vital sign deterioration in older cardiac surgery patients.
- Single center pilot study.
- 100 older patients undergoing cardiac surgery.
- Continuous remote monitoring of vital signs after ICU discharge
- Main study endpoint is vital sign deterioration.
Detailed description
Cardiac surgery in elderly patients aims to improve functional capacity and overall survival but may also precipitate major morbidity and mortality. Despite major improvements in the safety of anesthesia and surgery a significant number of elderly patients experience a complication after cardiac surgery.
To determine if postoperative remote monitoring of vital signs can be used to identify medication risk factors for vital sign deterioration in older cardiac surgery patients..
- Single center pilot study.
- 100 older patients undergoing cardiac surgery.
- Continuous remote monitoring of vital signs starts after ICU discharge
- PR, RR and SpO2 will be continuously monitored in all patients.
- Patients and healthcare personnel are blinded for monitoring results.
- Main study endpoint is vital sign deterioration.
The study population includes 100 patients ≥70 years undergoing elective cardiac surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study population includes 100 patients ≥70 years undergoing elective cardiac surgery.
Key inclusion criteria (1 listed)
- ≥70 years undergoing elective cardiac surgery.
Key exclusion criteria (1 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
Hypoxemia
Time frame: Three consecutive days after ICU discharge
Duration of sPO2 <80%, <85%, <90% and <95% in minutes per hour
Respiratory deterioration
Time frame: Three consecutive days after ICU discharge
Duration of respiratory rate <10 min-1, >20 min-1, >25 min-1, >30 min-1 in minutes per hour
Arrythmia
Time frame: Three consecutive days after ICU discharge
Duration of pulse rate <50 min-1, >100 min-1, >110 min-1, >120 min-1 in minutes per hour
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 21 Nov 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Hypoxemia
Enrolling by invitation
Extubation Safety Via Microstream EtCO₂ (IPI) Monitoring
Hypoxemia
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
RecruitingObservational study
Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
Respiratory Failure, Hypoxemia
Not yet recruitingObservational study
The Role of Ultrasonographic Tracheal Measurements in Predicting Hypoxemia During Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration
ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATION, Hypoxemia
Not yet recruiting
HFNC vs Conventional Oxygen During Gastrocolonoscopy in Elderly Patients
Hypoxemia, Eldery People
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxemia and Respiratory Failure, run by St. Antonius Hospital at 1 site in Netherlands.
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 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
Hypoxemia (time frame: Three consecutive days after ICU discharge). The study lists 3 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 21 Nov 2023.