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| Name | Class |
|---|---|
| Society of Critical Care Medicine | OTHER |
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Intensive care unit (ICU) patients on respirators are at high risk for preventable pulmonary complications (PPC). Turning these patients from side to side may reduce PPC, but carries the burden of decreases in blood pressure and oxygenation. The investigators hypothesize that there will be no difference in PPC or adverse events when ICU patients on respirators are turned by nurses or by an automated turning bed.
The purpose of this pilot study is to test the feasibility of two turning protocols and study procedures for a multi-site randomized clinical trial to evaluate efficacy and safety of horizontal positioning interventions to reduce pulmonary complications in mechanically ventilated critically ill adult patients. The hypothesis of the randomized controlled trial (RCT) is no difference in pulmonary complications between manual, 2-hourly lateral rotation to > 45 degrees (control), and continuous automated turning to 45 degrees (experimental) groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kinetic Therapy Bed | Experimental | Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days |
|
| Manual Turn | Active Comparator | Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual turn | Other | Manual turn from side to back to side every 2 hours by nurses while patient receiving mechanical ventilation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Pulmonary Complications. | Number of participants who did not have preventable pulmonary complications (PPC) on pre-study chest radiograph (CXR) and developed PPC during the study period. Pearson Chi-Square test used to test significance of difference between turning groups. | Participants were followed for the duration of ICU stay, an average of 10 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Mechanical Ventilation Duration. | Days on mechanical ventilation, from initiation to withdrawal of mechanical ventilation | Participants were followed for the duration of mechanical ventilation, an average of 5.5 days. |
| ICU Length of Stay. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandra K. Hanneman, PhD, RN | The University of Texas Health Science Center, Houston | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19606450 | Background | Padhye NS, Cron SG, Gusick GM, Hamlin SK, Hanneman SK. Randomization for clinical research: an easy-to-use spreadsheet method. Res Nurs Health. 2009 Oct;32(5):561-6. doi: 10.1002/nur.20341. | |
| 18510182 | Background | Hamlin SK, Hanneman SK, Wachtel S, Gusick G. Adverse hemodynamic effects of lateral rotation during mechanical ventilation. Dimens Crit Care Nurs. 2008 Mar-Apr;27(2):54-61. doi: 10.1097/01.dcc.0000311593.87097.6a. |
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Not applicable. All enrolled patients assigned to group.
Recruitment period spanned 8.6 months (between 09/28/07 - 04/30/07 and 05/01/09 - 08/31/09) and was done in 2 ICUs of 2 tertiary hospitals. Recruitment efforts were intermittent due to staffing resources and reconfiguration and testing of automated turn bed angle sensor.
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| ID | Title | Description |
|---|---|---|
| FG000 | Kinetic Therapy Bed | Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days |
| FG001 | Manual Turn | Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Kinetic Therapy Bed | Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days |
| BG001 | Manual Turn |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Pulmonary Complications. | Number of participants who did not have preventable pulmonary complications (PPC) on pre-study chest radiograph (CXR) and developed PPC during the study period. Pearson Chi-Square test used to test significance of difference between turning groups. | Intention to treat; all 8 patients enrolled in kinetic therapy bed turn and 7 of 8 patients enrolled in manual turn (1 died before protocol initiated) | Posted | Number | participants | Participants were followed for the duration of ICU stay, an average of 10 days. |
|
Time on protocol (7 days or less)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Kinetic Therapy Bed | Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Investig constructed | Systematic Assessment | Planned death with withdrawal of life support |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Discomfort:Psychologic | Psychiatric disorders | Investig constructed | Systematic Assessment | Includes such observations as anxiety, apprehension, confusion, disorientation, agitation, change in Richmond Agitation Sedation Scale score |
Reliance on chest X-ray interpretation only for detection of preventable pulmonary complications; small pilot study; kinetic therapy bed turn angle was less than 45 degrees
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sandra K. Hanneman, PhD, RN, FAAN | University of Texas Health Science Center at Houston | 713-500-2030 | Sandra.K.Hanneman@uth.tmc.edu |
| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
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| kinetic therapy bed | Device | Continuous, automated turning to a maximum of 45 degrees in the lateral positions while the patient is receiving mechanical ventilation |
|
|
Time in days from study ICU admission to study ICU discharge or death
| Participants were followed for the duration of ICU stay, an average of 10 days. |
| ICU All-cause Mortality. | Death from any reason between admission and discharge from study ICU | Participants were followed for the duration of ICU stay, an average of 10 days. |
| Turning-related Events | Non-serious adverse events that occurred during the time of rotation in the kinetic therapy bed group and during lateral rotation to right or left position in the manual turn group | Participants were followed for the duration of time on protocol, an average of 3.5 days. |
| 19963521 | Background | Padhye NS, Hamlin S, Brazdeikis A, Hanneman SK. Cardiovascular impact of manual and automated turns in ICU. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:1844-7. doi: 10.1109/IEMBS.2009.5332599. |
| 25554551 | Background | Hanneman SK, Gusick GM, Hamlin SK, Wachtel SJ, Cron SG, Jones DJ, Oldham SA. Manual vs automated lateral rotation to reduce preventable pulmonary complications in ventilator patients. Am J Crit Care. 2015 Jan;24(1):24-32. doi: 10.4037/ajcc2015171. |
| 25727273 | Background | Hamlin SK, Hanneman SK, Padhye NS, Lodato RF. Hemodynamic changes with manual and automated lateral turning in patients receiving mechanical ventilation. Am J Crit Care. 2015 Mar;24(2):131-40. doi: 10.4037/ajcc2015782. |
Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Vasopressor Use | Use of continuous intravenous infusion of any vasopressor during study period | Number | Participant |
|
| COPD Diagnosis | Diagnosis of chronic obstructive pulmonary disease (COPD) in medical record | Number | Participant |
|
| Surgery | Number | Participant |
|
| APACHE II | Score on the Acute Physiology and Chronic Health Evaluation (APACHE) II (acuity of illness)instrument. Score ranges from 0 to 71, with higher score indicating greater severity of illness and risk for mortality. | Mean | Standard Deviation | Scores on a scale |
|
| FIO2 | Fraction of inspired oxygen (FIO2) from APACHE II assessment (highest FIO2 within 24 hours of ICU admission) | Mean | Standard Deviation | Fraction |
|
Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days |
|
|
|
| Secondary | Mechanical Ventilation Duration. | Days on mechanical ventilation, from initiation to withdrawal of mechanical ventilation | All 8 patients enrolled in kinetic therapy bed group and 7 of 8 patients enrolled in manual turn group (1 death before study protocol initiated) | Posted | Mean | Standard Deviation | Days | Participants were followed for the duration of mechanical ventilation, an average of 5.5 days. |
|
|
|
|
| Secondary | ICU Length of Stay. | Time in days from study ICU admission to study ICU discharge or death | All 8 patients enrolled in kinetic therapy bed group and 7 of 8 patients enrolled in manual turn group (1 patient enrolled but died before started on protocol) | Posted | Median | Inter-Quartile Range | Days | Participants were followed for the duration of ICU stay, an average of 10 days. |
|
|
|
|
| Secondary | ICU All-cause Mortality. | Death from any reason between admission and discharge from study ICU | All 8 patients enrolled in the kinetic therapy bed group and 7 of the 8 patients enrolled in the manual turn group (1 patient died before start of study protocol) | Posted | Number | participants | Participants were followed for the duration of ICU stay, an average of 10 days. |
|
|
|
|
| Secondary | Turning-related Events | Non-serious adverse events that occurred during the time of rotation in the kinetic therapy bed group and during lateral rotation to right or left position in the manual turn group | All 8 patients enrolled in the kinetic therapy bed group and 7 of the 8 patients enrolled in the manual turn group (1 patient died after enrollment but before protocol could be initiated) | Posted | Mean | Standard Deviation | Events | Participants were followed for the duration of time on protocol, an average of 3.5 days. |
|
|
|
|
| 4 |
| 8 |
| 8 |
| 8 |
| EG001 | Manual Turn | Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days | 3 | 7 | 7 | 7 |
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| Dysrhythmia | Cardiac disorders | Investig constructed | Systematic Assessment | Includes tachycardia, atrial fibrillation, and supraventricular tachycardia |
|
| Hypoxemia | Respiratory, thoracic and mediastinal disorders | Investig constructed | Systematic Assessment | Marked decrease in peripheral oxygen saturation |
|
| Inadvertent extubation | Respiratory, thoracic and mediastinal disorders | Investig constructed | Systematic Assessment | Patient self-extubation |
|
| Hypertension | General disorders | Investig constructed | Systematic Assessment | Increase in mean arterial blood pressure > 20 mm Hg sustained for 5 minutes or more |
|
| Hypotension | General disorders | Investig constructed | Systematic Assessment | Decrease in mean arterial pressure > 20 mm Hg sustained for 5 minutes or more |
|
| Ventilator Disconnection | Respiratory, thoracic and mediastinal disorders | Investig constructed | Systematic Assessment | Inadvertent disconnection of ventilator from endotracheal tube |
|
| Ventilator malfunction | Respiratory, thoracic and mediastinal disorders | Investig constructed | Systematic Assessment |
|
|
| Pulmonary | Respiratory, thoracic and mediastinal disorders | Investig constructed | Systematic Assessment | Includes such observations and patient complaints as cough, shortness of breath, tachypnea, SpO2 changes \ |
|
| Hemodynamic | Vascular disorders | Investig constructed | Systematic Assessment | Includes such observations as change in systolic blood pressure \ |
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| Discomfort:Physiologic | General disorders | Investig constructed | Systematic Assessment | Includes such observations or patient complaints as faintness, dizziness, fear of falling, and pain |
|
| Miscellaneous | General disorders | Investig constructed | Systematic Assessment | Includes such observations as rectal thermometry probe/sensor displacement, neuromuscular manifestations, and bleeding |
|
| Skin | Skin and subcutaneous tissue disorders | Investig constructed | Systematic Assessment | Includes pressure ulcers and skin lesions other than pressure ulcers |
|
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| D012141 |
| Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |