Study: NCT00542321

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Planned death with withdrawal of life support
Frequency: 1 affected / 8 at risk

Adverse event: Dysrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Includes tachycardia, atrial fibrillation, and supraventricular tachycardia
Frequency: 1 affected / 8 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Marked decrease in peripheral oxygen saturation
Frequency: 1 affected / 8 at risk

Adverse event: Hypertension
Serious: yes
Organ System: General disorders
Notes: Increase in mean arterial blood pressure \> 20 mm Hg sustained for 5 minutes or more
Frequency: 3 affected / 8 at risk

Adverse event: Ventilator Disconnection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Inadvertent disconnection of ventilator from endotracheal tube
Frequency: 1 affected / 8 at risk

Adverse event: Discomfort:Psychologic
Serious: no
Organ System: Psychiatric disorders
Notes: Includes such observations as anxiety, apprehension, confusion, disorientation, agitation, change in Richmond Agitation Sedation Scale score
Frequency: 8 affected / 8 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Includes such observations and patient complaints as cough, shortness of breath, tachypnea, SpO2 changes \</= 4%, tension on the endotracheal tube/ventilator tubing, patient-ventilator dysynchrony, bronchial secretions, and cuff leak
Frequency: 8 affected / 8 at risk

Adverse event: Hemodynamic
Serious: no
Organ System: Vascular disorders
Notes: Includes such observations as change in systolic blood pressure \</= 19 mmHg and/or heart rate \</= 29 beats/min, and dysrhythmias
Frequency: 8 affected / 8 at risk

Adverse event: Discomfort:Physiologic
Serious: no
Organ System: General disorders
Notes: Includes such observations or patient complaints as faintness, dizziness, fear of falling, and pain
Frequency: 8 affected / 8 at risk

Adverse event: Miscellaneous
Serious: no
Organ System: General disorders
Notes: Includes such observations as rectal thermometry probe/sensor displacement, neuromuscular manifestations, and bleeding
Frequency: 6 affected / 8 at risk

Adverse event: Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Includes pressure ulcers and skin lesions other than pressure ulcers
Frequency: 1 affected / 8 at risk

Adverse event: Dysrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Includes tachycardia, atrial fibrillation, and supraventricular tachycardia
Frequency: 1 affected / 7 at risk

Adverse event: Inadvertent extubation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient self-extubation
Frequency: 1 affected / 7 at risk

Adverse event: Hypotension
Serious: yes
Organ System: General disorders
Notes: Decrease in mean arterial pressure \> 20 mm Hg sustained for 5 minutes or more
Frequency: 1 affected / 7 at risk

Adverse event: Ventilator malfunction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Discomfort:Psychologic
Serious: no
Organ System: Psychiatric disorders
Notes: Includes such observations as anxiety, apprehension, confusion, disorientation, agitation, change in Richmond Agitation Sedation Scale score
Frequency: 7 affected / 7 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Includes such observations and patient complaints as cough, shortness of breath, tachypnea, SpO2 changes \</= 4%, tension on the endotracheal tube/ventilator tubing, patient-ventilator dysynchrony, bronchial secretions, and cuff leak
Frequency: 7 affected / 7 at risk

Adverse event: Hemodynamic
Serious: no
Organ System: Vascular disorders
Notes: Includes such observations as change in systolic blood pressure \</= 19 mmHg and/or heart rate \</= 29 beats/min, and dysrhythmias
Frequency: 6 affected / 7 at risk

Adverse event: Discomfort:Physiologic
Serious: no
Organ System: General disorders
Notes: Includes such observations or patient complaints as faintness, dizziness, fear of falling, and pain
Frequency: 6 affected / 7 at risk

Adverse event: Miscellaneous
Serious: no
Organ System: General disorders
Notes: Includes such observations as rectal thermometry probe/sensor displacement, neuromuscular manifestations, and bleeding
Frequency: 4 affected / 7 at risk

Adverse event: Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Includes pressure ulcers and skin lesions other than pressure ulcers
Frequency: 3 affected / 7 at risk