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IRCT201508268650N6 IRCT 2016-04-01 Vice Chancellor for research of, Islamic Azad University branch of Medical Sciences Tehran Comparing the Open Endotracheal Suctioning and the Closed Endotracheal Suctioning Methods on the Level of Pain and Agitation of Patients under Mechanical Ventilation Comparing the Open Endotracheal Suctioning and the Closed Endotracheal Suctioning Methods on the Level of Pain and Agitation of Patients under Mechanical Ventilation 2015-04-01 anticipated 60 Complete https://irct.ir/trial/9140 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Patients with impaired respiratory function in ICU. Intervention 1: In the experimental group (open suction system) In the beginning, The vital signs were recorded by the monitor. The patient was then hyper-oxygenized with 100% oxygen. Immediately after that, endotracheal suctioning (open) was conducted rotationally for 10 to 15 seconds with a maximum pressure of 120 mm Hg. Following that, the patient was again hyper-oxygenated with 100% oxygen, and hemodynamic variables were recorded at five temporal stages for both groups with the monitoring device. The pain and agitation of the two groups were measured using the Richmond Agitation Sedation Scale at five temporal stages (before, during, immediately, 5 minutes after the suctioning, and 15 minutes after the suctioning). Intervention 2: In the experimental group (close suction system) In the beginning, The vital signs were recorded by the monitor. The patient was then hyper-oxygenized with 100% oxygen. Immediately after that, endotracheal suctioning(close) was conducted rotationally for 10 to 15 seconds with a maximum pressure of 120 mm Hg. Following that, the patient was again hyper-oxygenated with 100% oxygen, and hemodynamic variables were recorded at five temporal stages for both groups with the monitoring device. The pain and agitation of the two groups were measured using the Richmond Agitation Sedation Scale at five temporal stages (before, during, immediately, 5 minutes after the suctioning, and 15 minutes after the suctioning).
public Raziyeh Dastdadeh
Khaghani st, Shariati Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 193951495 +98 21 2200 6660 r.dastdadeh@gmail.com School of Nursing and Midwifery, Islamic Azad University of Tehran scientific Dr.Abbas Ebadi
Molla sadra st,Tehran,Iran
Tehran Iran (Islamic Republic of) 00 ebadi1347@bmsu.ac.ir Baqiyatallah University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: The criteria for entering the study consisted of being 18 years of age or older, being an intubated (having a tube in the trachea) and mechanically ventilated patient, having a consciousness level with a Glasgow coma score of 7 or higher, having vital signs within normal limits, not having taken high-dose sedatives and tranquilizers (deep sedition) during the past six hours, having no severe facial trauma, taking dopamine, dobutamine and nitroglycerin according to the physician's orders (not taking them in unconventional doses), having a normal hearing and speaking ability and not being dependent on utilities such as hearing aids, not suffering from a neurological damage affecting breathing (such as quadriplegia), having no record of mental illness and severe neurological problems, and not being affected by neuromuscular diseases. The exclusion criteria consisted of not receiving the patient’s companion’s consent, tracheal extubation, patient’s being in need of repeated suctioning or suctioning in intervals shorter than 20 minutes, having a reduced level of consciousness during suctioning, dysrhythmia, suffering from a reduced SPO2 level more than 10% during suctioning, and being in need of tranquilizers and painkillers more than the common treatment protocol. 18 years 94 years Both J95 , J96 Other diseases of the respiratory system Prevention Prevention In the experimental group (open suction system) In the beginning, The vital signs were recorded by the monitor. The patient was then hyper-oxygenized with 100% oxygen. Immediately after that, endotracheal suctioning (open) was conducted rotationally for 10 to 15 seconds with a maximum pressure of 120 mm Hg. Following that, the patient was again hyper-oxygenated with 100% oxygen, and hemodynamic variables were recorded at five temporal stages for both groups with the monitoring device. The pain and agitation of the two groups were measured using the Richmond Agitation Sedation Scale at five temporal stages (before, during, immediately, 5 minutes after the suctioning, and 15 minutes after the suctioning). In the experimental group (close suction system) In the beginning, The vital signs were recorded by the monitor. The patient was then hyper-oxygenized with 100% oxygen. Immediately after that, endotracheal suctioning(close) was conducted rotationally for 10 to 15 seconds with a maximum pressure of 120 mm Hg. Following that, the patient was again hyper-oxygenated with 100% oxygen, and hemodynamic variables were recorded at five temporal stages for both groups with the monitoring device. The pain and agitation of the two groups were measured using the Richmond Agitation Sedation Scale at five temporal stages (before, during, immediately, 5 minutes after the suctioning, and 15 minutes after the suctioning). Severity of Pain. Timepoint: Before, during, immediately after the intervention, 5 minutes and 15 minutes after intervention. Method of measurement: BPS. Agitation. Timepoint: Before, during, immediately after the intervention, 5 minutes and 15 minutes after intervention. Method of measurement: Richmond Agitation Sedation Scale. Heart rate. Timepoint: Before, during, immediately after the intervention, 5 minutes and 15 minutes after intervention. Method of measurement: Monitoring Device. SPO2. Timepoint: Before, during, immediately after the intervention, 5 minutes and 15 minutes after intervention. Method of measurement: Monitoring Device. Respiration rate. Timepoint: Before, during, immediately after the intervention, 5 minutes and 15 minutes after intervention. Method of measurement: Monitoring Device. Systolic Blood Pressure. Timepoint: Before, during, immediately after the intervention, 5 minutes and 15 minutes after intervention. Method of measurement: Monitoring Device. Mean Arterial Blood Pressure. Timepoint: Before, during, immediately after the intervention, 5 minutes and 15 minutes after intervention. Method of measurement: Monitoring Device. Diastolic Blood Pressure. Timepoint: Before, during, immediately after the intervention, 5 minutes and 15 minutes after intervention. Method of measurement: Monitoring Device. Vice Chancellor for research of, Islamic Azad University branch of Medical Sciences Tehran Approved 2016-02-24 Islamic Azad University Ethics Committee Medical Branch of Tehran Khaghani st, Shariati Ave, Tehran, Iran Tehran Iran (Islamic Republic of)