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IRCT20110912007529N16 IRCT 2017-12-27 Vice chancellor for research, Shahed University Effects of acupressure therapy on patients weaning from mechanical ventilation Effects of acupressure therapy on anxiety, agitation and physiologic parameters in patients weaning from mechanical ventilation 2017-11-22 anticipated 80 Complete https://irct.ir/trial/8024 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: Eligible patients will be selected through convenience sampling and will be randomly assigned into 2 groups using permuted block randomization with allocation ratio of 1:1. Random allocation sequence will be determined using a computerized program. Opaque sealed sequentially numbered envelopes from number 1 to 80 will be used for allocation concealment, Randomization description: Eligible patients will be randomly assigned into two groups using permuted block randomization , Random numbers table will be used, Random allocation sequence will be determined using a computerized program.Opaque sealed sequentially numbered envelopes from number 1 to 80 will be used for allocation concealment, Blinding description: patients will be unaware of the groups’assignments.staff nurses in the ICU and the statistical analyzer will be blind to patients’allocation of the groups. N/A Patients with impaired respiratory function in ICU. Intervention 1: The experiment group: Acupressure will be performed in this group. The intervention is performed 20 minutes before weaning of mechanically ventilation by a trained person. This technique will be implemented at 5- acupoints on both sides of the body. The 5- acupoints include Zhongfu (Lu1), Taiyuan (Lu9), Hegu (Li4), Neiguan (Pc6) and Zusanli (St36). This technique will be performed on one side of the body first and then the other side of the body based on the patient's condition. Anxiety, agitation and physiologic parameters are measured before the intervention, immediately after the intervention, under T-piece and 20 min after T-piece. T–piece device is placed on the tracheal tube and a high level of oxygen is given to the patients. In addition to administering oxygen, the device can produce about 5 cm PEEP water and an increase in PaCo2 by providing an exhale-resistant resistor. Intervention 2: In control group, touch will be performed at 5 points except the main points in intervention group, 20 minutes before weaning of mechanical ventilation. Anxiety, agitation, and physiologic parameters will be measured before the intervention, immediately after the intervention, under T-piece and 20 min after T-piece. Undecided - It is not yet known if there will be a plan to make this available
public Dr. Nahid Rejeh
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way, Tehran.
Tehran Iran (Islamic Republic of) 3319118651 +98 21 5121 3071 nrejeh@yahoo.com Shahed University scientific Dr. Nahid Rejeh
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way Tehran.
Tehran Iran (Islamic Republic of) 3319118651 +98 21 5121 3071 nrejeh@yahoo.com Shahed University Iran (Islamic Republic of) Four score ≥ 9 Richmond score from +2 to -2 PaO2 ≥ 60 mmHg ، ABG: FiO2 ≤ 40%، PaO2 ≥ 60 mmHg, 25≥ RR) age over 18 being intubated during past 48 hours being on ventilation with SIMV and PSV mode Hemoglobin ≥ 8 mg/dl Absence of malformation or grazes in pressure points Absence of psychiatric illness Absence of neuromuscular illness Absence of active heart disease Absence of neurologic disorder that affects respiratory not taking any psychiatric agent not taking any neuromuscular blocker agent not taking sedative during past 4 hours absence of coagulation disturbance (PTT≤60) 18 years no limit Female Exclusion criteria :Patient with no cooperation to end of study ; Weaning of mechanical ventilation ; Death of patient during the study ; Daley of weaning process. J95 , J96 Other diseases of the respiratory system Treatment - Other Treatment - Other The experiment group: Acupressure will be performed in this group. The intervention is performed 20 minutes before weaning of mechanically ventilation by a trained person. This technique will be implemented at 5- acupoints on both sides of the body. The 5- acupoints include Zhongfu (Lu1), Taiyuan (Lu9), Hegu (Li4), Neiguan (Pc6) and Zusanli (St36). This technique will be performed on one side of the body first and then the other side of the body based on the patient's condition. Anxiety, agitation and physiologic parameters are measured before the intervention, immediately after the intervention, under T-piece and 20 min after T-piece. T–piece device is placed on the tracheal tube and a high level of oxygen is given to the patients. In addition to administering oxygen, the device can produce about 5 cm PEEP water and an increase in PaCo2 by providing an exhale-resistant resistor. In control group, touch will be performed at 5 points except the main points in intervention group, 20 minutes before weaning of mechanical ventilation. Anxiety, agitation, and physiologic parameters will be measured before the intervention, immediately after the intervention, under T-piece and 20 min after T-piece. Anxiety. Timepoint: before intervention, immediately after intervention, under T-Piece, 20 min after T-Piece. Method of measurement: by Faces anxiety scale. Agitation. Timepoint: before intervention, immediately after intervention, under T-Piece, 20 min after T-Piece. Method of measurement: Richmond Scale. Heart rate. Timepoint: Before intervention, immediately after intervention, under T-Piece, 20 min after T-Piece. Method of measurement: Monitoring system. Respiratory rate. Timepoint: Before intervention, immediately after intervention, under T-Piece, 20 min after T-Piece. Method of measurement: Ventilator system. Oxygen saturation of arterial blood ( SPo2 ). Timepoint: Before intervention, immediately after intervention, under T-Piece, 20 min after T-Piece. Method of measurement: Pulsoximeter. Heart rate. Timepoint: Before intervention, immediately after intervention, under T-Piece, 20 min after T-Piece. Method of measurement: Monitoring system. Systolic Blood pressure. Timepoint: Before intervention, immediately after intervention, under T-Piece, 20 min after T-Piece. Method of measurement: Monitoring system. Diastolic blood pressure. Timepoint: Before intervention, immediately after intervention, under T-Piece, 20 min after T-Piece. Method of measurement: Monitoring system. Mean blood pressure. Timepoint: Before intervention, immediately after intervention, under T-Piece, 20 min after T-Piece. Method of measurement: Monitoring system. Tidal Volume. Timepoint: Before intervention, immediately after intervention, under T-Piece, 20 min after T-Piece. Method of measurement: Monitoring system. Minute Ventilation. Timepoint: Before intervention, immediately after intervention, under T-Piece, 20 min after T-Piece. Method of measurement: Monitoring system. Vice chancellor for research, Shahed University Approved 2017-11-06 Ethics committee of Shahed University Shahed University, Opposite the Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, Tehran. Tehran Tehran Iran (Islamic Republic of)