Patients After Surgery and Anesthesia Monitored in the PACUNCT00659516
Smart Capnography Respiratory Index in Post Anesthesia Patients
An observational study of Patients After Surgery and Anesthesia Monitored in the PACU, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
The smart capnography respiratory index is a software tool that constitutes a representation of 4 parameters: End Tidal CO2, respiratory rate, O2 saturation and heart rate already displayed on a monitor in the form of a single respiratory index integer value ranging from 1 to 10 with trend information. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patients After Surgery and Anesthesia Monitored in the PACU
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- May 2008to Dec 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: the respiratory index evaluation will be performed on 40 patients (adult and pediatric) of which 30 will be non intubated
Who may be able to join
- Adult or pediatric patients after surgery and anesthesia, monitored in the PACU
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Israel1 site
Shaare Zedek Medical Center
Jerusalem, 91031
Yaacov Gozal, MD, 972-50-8685831, gozaly@szmc.org.il
Yaacov Gozal, MD
About this study
Official title: Smart Capnography Respiratory Index: Clinical Evaluation
The smart capnography respiratory index is a software tool that constitutes a representation of 4 parameters: End Tidal CO2, respiratory rate, O2 saturation and heart rate already displayed on a monitor in the form of a single respiratory index integer value ranging from 1 to 10 with trend information. The index is to be used to identify and display status and changes in patient respiratory status in a simple manner based on the summary of changes in the 4-above mentioned parameters. the respiratory index is to be used in varied clinical environments and is intended for use in adult and pediatric patients.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | intubated patients | |
| 2 | non intubated patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate that the displayed respiratory index values and their associated description match the clinical status of the patients
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionAug 2008 (estimated)
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients After Surgery and Anesthesia Monitored in the PACUStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Yaacov Gozal, MD, Principal investigator, Shaare Zedek Medical center Jerusalem, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00659516
- Sponsor's protocol ID
- 123
- Status last verified
- Apr 2008
- First submitted
- 14 Apr 2008
- Last updated
- 16 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Capnography Respiratory Index: Clinical Evaluation
- ClinicalTrials.gov ID
- NCT00659516
- Acronym / sponsor ID
- 123
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Aug 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 16 Apr 2008 (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.
The smart capnography respiratory index is a software tool that constitutes a representation of 4 parameters: End Tidal CO2, respiratory rate, O2 saturation and heart rate already displayed on a monitor in the form of a single respiratory index integer value ranging from 1 to 10 with trend information. The index is to be used to identify and display status and changes in patient respiratory status in a simple manner based on the summary of changes in the 4-above mentioned parameters. the respiratory index is to be used in varied clinical environments and is intended for use in adult and pediatric patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –intubated patients |
| 2 | – | –non intubated patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- the respiratory index evaluation will be performed on 40 patients (adult and pediatric) of which 30 will be non intubated
Key inclusion criteria (1 listed)
- Adult or pediatric patients after surgery and anesthesia, monitored in the PACU
Key exclusion criteria (1 listed)
- none
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
To demonstrate that the displayed respiratory index values and their associated description match the clinical status of the patients
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2008.
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.
Yaacov Gozal, MD principal investigator
Shaare Zedek Medical center Jerusalem, Israel
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 Patients After Surgery and Anesthesia Monitored in the PACU, run by Shaare Zedek Medical Center at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 16 Apr 2008. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yaacov Gozal, MD (972-50-8685831, gozaly@szmc.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate that the displayed respiratory index values and their associated description match the clinical status of the patients (time frame: 3 months). 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 16 Apr 2008.