Demographics of Intubated Patients Due to an Urgent CallICUNCT02216929
Assessment of the Patients of Emergency Consultation
An observational study of Demographics of Intubated Patients Due to an Urgent Call, run by Gulsah Karaoren at 1 site in Turkey (Türkiye).
Trial summary
The demographic data, mortality rates and clinical diagnoses of the patients who were evaluated, intubated and interned to ICU by the anesthesiology department due to an urgent consultation call from the emergency department in 2010-2011. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Demographics of Intubated Patients Due to an Urgent Call
- How many people
- 287 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2011to May 2011
- 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: This study aimed to retrospectively evaluate patients throughout the whole hospital who were intubated and interned to the ICU by anaesthesiology team due to an urgent consultation call in our hospital during 2010-2011.
Who may be able to join
- patients throughout the hole hospital whom was intubated by the anaesthesiology team due to an urgent consultation call
Who cannot join
- patients who refused treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Faculty of Cerrahpasa Medicine
Istanbul
About this study
Official title: The Demographics, Mortality and Clinical Diagnosis of the Patients Who Were Evaluated, Intubated and Interned to ICU by the Anesthesiology in 2010-2011
The demographic data, mortality rates and clinical diagnoses of the patients who were evaluated, intubated and interned to ICU by the anesthesiology department due to an urgent consultation call from the emergency department in 2010-2011.
Primary outcome: an examination of demographic data, predicted mortality rates and the clinical diagnosis of the patients Secondary outcome: to determine the terminal cancer ratio Inclusion criteria: patients throughout the hole hospital whom was intubated by the anaesthesiology team due to an emergency consultation call Exclusion criteria: patients who refused treatment
Read the detailed description
The demographic data and findings completed in the Emergency Department were obtained from the patient cards and information related to existing diseases was obtained from the patient records for the cases included in the study.
Predicted mortality values were calculated for each patient with Apache II and SAPS II values using the worst or most critical physiological and laboratory parameters in the first 24 hours in the Emergency Department.
- Keywords
- intubation, intensive care, withholding treatment, cancer, terminal care, APACHE
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The evaluation of the terminal phase cancer ratio
To determine the ratio of patients with terminal phase cancer who were intubated and interned to the intensive care unit.
Measured: 12 months
Secondary outcomes (1)
Demographic data of urgent anaesthesiology consultations required intubation
The evaluation of the demographics, clinical diagnosis and the calculated values of APACHE II, SAPS II and predicted mortality of the patients who were intubated and interned to the ICU by anesthesiology department due to an urgent consultation call.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startJan 2011
- Primary completionMar 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Demographics of Intubated Patients Due to an Urgent CallStudies 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
- Time perspective
- Retrospective
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulsah Karaoren
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Gulsah Karaoren, Umraniye Education and Research Hospital
- Investigators
- Huseyin Oz, Prof Dr, Study director, Medipol University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216929
- Sponsor's protocol ID
- GK2
- Acronym
- ICU
- Status last verified
- Jan 2011
- First submitted
- 13 Aug 2014
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim AS, Youn CH, Ko HJ, Kim HM. The survival time of terminal cancer patients: prediction based on clinical parameters and simple prognostic scores. J Palliat Care. 2014 Spring;30(1):24-31.
PubMed 24826440Uy J, White DB, Mohan D, Arnold RM, Barnato AE. Physicians' decision-making roles for an acutely unstable critically and terminally ill patient. Crit Care Med. 2013 Jun;41(6):1511-7. doi: 10.1097/CCM.0b013e318287f0dd.
PubMed 23552510Lissauer ME, Naranjo LS, Kirchoffner J, Scalea TM, Johnson SB. Patient characteristics associated with end-of-life decision making in critically ill surgical patients. J Am Coll Surg. 2011 Dec;213(6):766-70. doi: 10.1016/j.jamcollsurg.2011.09.003.
PubMed 22107920
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Demographics, Mortality and Clinical Diagnosis of the Patients Who Were Evaluated, Intubated and Interned to ICU by the Anesthesiology in 2010-2011
- ClinicalTrials.gov ID
- NCT02216929
- Acronym / sponsor ID
- ICU / GK2
- Keywords
- intubation, intensive care, withholding treatment, cancer, terminal care, APACHE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Gulsah KaraorenOther government
- Study start
- Jan 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 15 Aug 2014 (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 demographic data, mortality rates and clinical diagnoses of the patients who were evaluated, intubated and interned to ICU by the anesthesiology department due to an urgent consultation call from the emergency department in 2010-2011.
Primary outcome: an examination of demographic data, predicted mortality rates and the clinical diagnosis of the patients Secondary outcome: to determine the terminal cancer ratio Inclusion criteria: patients throughout the hole hospital whom was intubated by the anaesthesiology team due to an emergency consultation call Exclusion criteria: patients who refused treatment
Detailed description
The demographic data and findings completed in the Emergency Department were obtained from the patient cards and information related to existing diseases was obtained from the patient records for the cases included in the study.
Predicted mortality values were calculated for each patient with Apache II and SAPS II values using the worst or most critical physiological and laboratory parameters in the first 24 hours in the Emergency Department.
Study design
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study aimed to retrospectively evaluate patients throughout the whole hospital who were intubated and interned to the ICU by anaesthesiology team due to an urgent consultation call in our hospital during 2010-2011.
Key inclusion criteria (1 listed)
- patients throughout the hole hospital whom was intubated by the anaesthesiology team due to an urgent consultation call
Key exclusion criteria (1 listed)
- patients who refused treatment
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
The evaluation of the terminal phase cancer ratio
Time frame: 12 months
To determine the ratio of patients with terminal phase cancer who were intubated and interned to the intensive care unit.
1 secondary outcome
Demographic data of urgent anaesthesiology consultations required intubation
Time frame: 12 months
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 15 Aug 2014.
- Background: PubMed 24826440Kim AS, Youn CH, Ko HJ, Kim HM. The survival time of terminal cancer patients: prediction based on clinical parameters and simple prognostic scores. J Palliat Care. 2014 Spring;30(1):24-31.
- Background: PubMed 23552510Uy J, White DB, Mohan D, Arnold RM, Barnato AE. Physicians' decision-making roles for an acutely unstable critically and terminally ill patient. Crit Care Med. 2013 Jun;41(6):1511-7. doi: 10.1097/CCM.0b013e318287f0dd.
- Results publication: PubMed 22107920Lissauer ME, Naranjo LS, Kirchoffner J, Scalea TM, Johnson SB. Patient characteristics associated with end-of-life decision making in critically ill surgical patients. J Am Coll Surg. 2011 Dec;213(6):766-70. doi: 10.1016/j.jamcollsurg.2011.09.003.
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.
Huseyin Oz, Prof Dr study director
Medipol University Faculty of Medicine
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 Demographics of Intubated Patients Due to an Urgent Call, run by Gulsah Karaoren at 1 site in Turkey (Türkiye).
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 15 Aug 2014. 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 Turkey (Türkiye). 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?
The evaluation of the terminal phase cancer ratio (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02216929, which also lists 3 linked publications.
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 15 Aug 2014.