Vital signs are measurements of physiological parameters that provide information about the basic body functions of an individual. They are routinely measured in clinical trials to assess the safety and efficacy of a drug or medical device. Vital signs typically include:
Body temperature: This is a measure of the internal body temperature and is usually measured using a thermometer placed in the mouth, under the arm, or in the rectum.
Blood pressure: This is the pressure of the blood against the walls of the arteries and is usually measured using a blood pressure cuff and a stethoscope.
Heart rate: This is the number of times the heart beats per minute and is usually measured by placing a finger on the pulse at the wrist, neck, or groin.
Respiratory rate: This is the number of breaths a person takes per minute and is usually measured by counting the number of times the chest rises and falls in one minute.
Oxygen saturation: This is the percentage of oxygen in the blood and is usually measured using a pulse oximeter that clips onto a finger.
Weight: This is the measure of the body mass and is usually measured using a scale.
Vital signs are important indicators of a person's health and can be affected by various factors such as illness, injury, medication, and exercise. In clinical trials, vital signs are measured at regular intervals to monitor the health of the participants and to detect any adverse events that may be related to the study intervention. The data collected from the vital signs assessments are analyzed to determine the safety and efficacy of the study intervention and to make recommendations for clinical practice.