- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00645008
Identification of Dominate Stressors in the Intensive Care Unit (ICU)
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.
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- The NewYork-Presbyterian Hospital-Weill Cornell Medical College, Cardiothoracic Intensive Care Unit (4W) - NYPH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Admitted to the CT-ICU for greater than 4 days (>96 hours)
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Identification of stressors present in the CT-ICU (as recognized by completed surveys)
Time Frame: Analysis after completion of 80 surveys
|
Analysis after completion of 80 surveys
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction and/or elimination of dominate stressors present in the CT-ICU
Time Frame: Analysis after completion of 160 surveys
|
Analysis after completion of 160 surveys
|
Collaborators and Investigators
Investigators
- Principal Investigator: Gregory Kerr, MD, MBA, The NewYork-Presbyterian Hospital-Weill Cornell Medical College
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 0801009626
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiac Surgery Intensive Care Treatment
-
BiPS MedicalTel-Aviv Sourasky Medical Center; Carmel Medical CenterUnknownIntensive Care Unit Patients | Post-cardiac SurgeryIsrael
-
University of Sao Paulo General HospitalCompletedCardiac Surgery | Physiotherapy | Adverse Event | Intensive Care Units | Postoperative
-
GCP-Service International West GmbHCharite University, Berlin, Germany; Wuerzburg University HospitalRecruitingCardiac Surgery | Cardiopulmonary Bypass | Intensive Care Unit | High Risk Patients | Valve SurgeriesGermany
-
Mayo ClinicNot yet recruitingCardiac Surgery | Intensive Care UnitUnited States
-
Assistance Publique - Hôpitaux de ParisInstitut National de la Santé Et de la Recherche Médicale, France; Société...CompletedAnemia | Cardiac Surgery | Intensive CareFrance
-
Assistance Publique - Hôpitaux de ParisINSERM UMR-942, Paris, FranceRecruitingBlood Pressure | Surgery | General Anesthesia | Intensive Care | Hemodynamic Instability | Cardiac Output | Interventional Radiology | Organ FailureFrance
-
Medline IndustriesTerminatedSurgery | Intensive Care Units
-
University of Massachusetts, WorcesterRecruitingBlood Pressure | Surgery | Intensive Care UnitUnited States
-
Peking University First HospitalPeking University Third Hospital; Beijing HospitalRecruitingSurgery | Elderly | Dexmedetomidine | Intensive Care Unit | Overall SurvivalChina
-
Yonsei UniversityCompletedICU(Intensive Care Unit) Patients | Mechanical Ventilation After SurgeryKorea, Republic of