Cardiac Surgery Intensive Care TreatmentNCT00645008
Identification of Dominate Stressors in the Intensive Care Unit (ICU)
An observational study of Cardiac Surgery Intensive Care Treatment, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
Undergoing cardiopulmonary bypass surgery and the subsequent admission to the intensive care unit (ICU) is known to be a stressful event to the patient. As patients prepare for open-heart surgery it is natural for them to feel anxious and concerned about all the various procedures involved in the process. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cardiac Surgery Intensive Care Treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Jun 2013
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study involves patients both male and female who are admitted to the intensive care unit immediately following cardiopulmonary bypass for either myocardial revascularization or valvular surgery.
Who may be able to join
- Admitted to the ICU following cardiopulmonary bypass surgery (AVR/MVR and/or CABG)
- Conscious, alert and having the capacity to consent and answer survey questions, i.e. no dementia
- Adults > 18 years old
Who cannot join
- Admitted to the CT-ICU for greater than 4 days (>96 hours)
Trial locations and contacts
1 site in 1 country.
United States1 site
The NewYork-Presbyterian Hospital-Weill Cornell Medical College, Cardiothoracic Intensive Care Unit (4W) - NYPH
New York, New York, 10065
About this study
Official title: Stressors Associated With Cardiac Surgery Intensive Care Treatment
Undergoing cardiopulmonary bypass surgery and the subsequent admission to the intensive care unit (ICU) is known to be a stressful event to the patient. As patients prepare for open-heart surgery it is natural for them to feel anxious and concerned about all the various procedures involved in the process. Members of both the surgical and anesthesia team explain the purpose of each procedure and all issues associated with the procedures in great detail in order to better prepare the patient, ease their anxiety and aid their recovery.
The underlying assumption for past investigations into overall patient satisfaction has been that the stressors inherent in the experience of illness and hospitalization have an adverse effect on patient recovery and can possibly prolong the recuperative process. Previous studies have shown that the specific performance of a team in regard to the effects of the stressors on the patient's status is key to providing optimal patient care in the ICU environment. Since the ICU stay is a difficult experience in the life of a patient, stressor predictability might allow for better physical and psychological conditions for the patient's recovery.
Read more
Although there is a myriad of published research available on the potential stressors related to an ICU stay, there is a dearth of investigation into the inherently more intense circumstances surrounding a stay in the Cardiothoracic Intensive Care Unit (CT-ICU). By examining the stressors in the CT-ICU changes can be made by the medical care team and/or hospital that can ultimately enhance the patient experience in the CT-ICU.
The purpose of this study is to reduce or completely eliminate stressors present in the CT-ICU as identified by the cardiac bypass patient. Identification of events and conditions considered stressful in the ICU will allow the professional team to determine which stressors are amendable to intervention and tailor patient care accordingly.
Read the detailed description
Hypothesis: Identification of events and conditions considered stressful by the cardiopulmonary bypass patient would allow the professional team to determine which stressors are amendable to intervention and tailor patient care accordingly in order to improve future patient care experience in the intensive care unit.
Research Question: What are the dominant stressors associated with intensive care treatment as perceived by the patient, and what measures can be taken by the professional team members of the unit to decrease or eliminate these stressors entirely?
Purpose: The purpose of this study is to reduce or completely eliminate stressors present in the CT-ICU as identified by the coronary bypass patient. Identification of events and conditions considered stressful in the ICU will allow the professional team to determine which stressors are amendable to intervention and tailor patient care accordingly.
Design: Analytical survey
Protocol: Patients will be selected based on admission to the ICU following cardiopulmonary bypass surgery. We plan to survey 160 patients in order to identify the main stressors in the ICU as perceived by the patient themselves. A study investigator will enroll subjects after obtaining oral informed consent. We plan to approach eligible candidates once they have been discharged from the ICU to the step-down unit (4C). Subjects will be asked to complete a short questionnaire that will ask them to assess stressors associated with their stay in the CT-ICU. Preliminary analysis will be done to appraise the leading stressors after enrolling 80 patients in the study. Once dominate stressors have been identified, we will conduct several in-services in order to educate the CT-ICU team members of the amendable stressors. We will then enroll another 80 patients in order to evaluate whether or not the stressors have been reduced and/or eliminated.
- Conditions
- Cardiac Surgery Intensive Care Treatment
- Keywords
- Stressors, Patient Satisfaction, Cardiothoracic-Intensive Care Unit, Coronary bypass patient
- Medical subject headings
- Patient Satisfaction
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of stressors present in the CT-ICU (as recognized by completed surveys)
Measured: Analysis after completion of 80 surveys
Secondary outcomes (1)
Reduction and/or elimination of dominate stressors present in the CT-ICU
Measured: Analysis after completion of 160 surveys
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgery Intensive Care TreatmentStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory Kerr, MD, MBA, Principal investigator, The NewYork-Presbyterian Hospital-Weill Cornell Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00645008
- Sponsor's protocol ID
- 0801009626
- Status last verified
- Feb 2017
- First submitted
- 19 Mar 2008
- Last updated
- 6 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stressors Associated With Cardiac Surgery Intensive Care Treatment
- ClinicalTrials.gov ID
- NCT00645008
- Acronym / sponsor ID
- 0801009626
- Conditions
- Cardiac Surgery Intensive Care Treatment
- Keywords
- Stressors, Patient Satisfaction, Cardiothoracic-Intensive Care Unit, Coronary bypass patient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Apr 2008 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 27 Mar 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.
Undergoing cardiopulmonary bypass surgery and the subsequent admission to the intensive care unit (ICU) is known to be a stressful event to the patient. As patients prepare for open-heart surgery it is natural for them to feel anxious and concerned about all the various procedures involved in the process. Members of both the surgical and anesthesia team explain the purpose of each procedure and all issues associated with the procedures in great detail in order to better prepare the patient, ease their anxiety and aid their recovery.
The underlying assumption for past investigations into overall patient satisfaction has been that the stressors inherent in the experience of illness and hospitalization have an adverse effect on patient recovery and can possibly prolong the recuperative process. Previous studies have shown that the specific performance of a team in regard to the effects of the stressors on the patient's status is key to providing optimal patient care in the ICU environment. Since the ICU stay is a difficult experience in the life of a patient, stressor predictability might allow for better physical and psychological conditions for the patient's recovery.
Although there is a myriad of published research available on the potential stressors related to an ICU stay, there is a dearth of investigation into the inherently more intense circumstances surrounding a stay in the Cardiothoracic Intensive Care Unit (CT-ICU). By examining the stressors in the CT-ICU changes can be made by the medical care team and/or hospital that can ultimately enhance the patient experience in the CT-ICU.
The purpose of this study is to reduce or completely eliminate stressors present in the CT-ICU as identified by the cardiac bypass patient. Identification of events and conditions considered stressful in the ICU will allow the professional team to determine which stressors are amendable to intervention and tailor patient care accordingly.
Detailed description
Hypothesis: Identification of events and conditions considered stressful by the cardiopulmonary bypass patient would allow the professional team to determine which stressors are amendable to intervention and tailor patient care accordingly in order to improve future patient care experience in the intensive care unit.
Research Question: What are the dominant stressors associated with intensive care treatment as perceived by the patient, and what measures can be taken by the professional team members of the unit to decrease or eliminate these stressors entirely?
Purpose: The purpose of this study is to reduce or completely eliminate stressors present in the CT-ICU as identified by the coronary bypass patient. Identification of events and conditions considered stressful in the ICU will allow the professional team to determine which stressors are amendable to intervention and tailor patient care accordingly.
Design: Analytical survey
Protocol: Patients will be selected based on admission to the ICU following cardiopulmonary bypass surgery. We plan to survey 160 patients in order to identify the main stressors in the ICU as perceived by the patient themselves. A study investigator will enroll subjects after obtaining oral informed consent. We plan to approach eligible candidates once they have been discharged from the ICU to the step-down unit (4C). Subjects will be asked to complete a short questionnaire that will ask them to assess stressors associated with their stay in the CT-ICU. Preliminary analysis will be done to appraise the leading stressors after enrolling 80 patients in the study. Once dominate stressors have been identified, we will conduct several in-services in order to educate the CT-ICU team members of the amendable stressors. We will then enroll another 80 patients in order to evaluate whether or not the stressors have been reduced and/or eliminated.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study involves patients both male and female who are admitted to the intensive care unit immediately following cardiopulmonary bypass for either myocardial revascularization or valvular surgery.
Key inclusion criteria (3 listed)
- Admitted to the ICU following cardiopulmonary bypass surgery (AVR/MVR and/or CABG)
- Conscious, alert and having the capacity to consent and answer survey questions, i.e. no dementia
- Adults > 18 years old
Key exclusion criteria (1 listed)
- Admitted to the CT-ICU for greater than 4 days (>96 hours)
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
Identification of stressors present in the CT-ICU (as recognized by completed surveys)
Time frame: Analysis after completion of 80 surveys
1 secondary outcome
Reduction and/or elimination of dominate stressors present in the CT-ICU
Time frame: Analysis after completion of 160 surveys
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 6 Feb 2017.
- Individual participant dataSharing planned: No. Will not be shared
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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.
Gregory Kerr, MD, MBA principal investigator
The NewYork-Presbyterian Hospital-Weill Cornell Medical College
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 Cardiac Surgery Intensive Care Treatment, run by Weill Medical College of Cornell University at 1 site in United States.
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 3 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 6 Feb 2017. 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 United States. 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?
Identification of stressors present in the CT-ICU (as recognized by completed surveys) (time frame: Analysis after completion of 80 surveys). 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 6 Feb 2017.