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IRCT201201098665N1 IRCT 2012-07-04 Semnan University of Medical Sciences Comparison effect of two implemented sedation methods (Scale & protocol) by nurses on some consequences of mechanical ventilation in intensive care patients Comparison effect of two implemented sedation methods (Scale & protocol) by nurses on some consequences of mechanical ventilation in intensive care patients 2012-06-21 anticipated 25 Complete https://irct.ir/trial/9151 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research. N/A Condition 1: pneumonia due to mechanical ventilation. Condition 2: mechanical ventilation duration. Condition 3: intra tracheal tube duration. Condition 4: time each of mechanical ventilation mode. Intervention 1: after finishing control group sampling, randomly in one section of ICU ward of Alzahra Hospital of Isfahan implement scale and in another part protocol. it is noticeable that selection of patients are based on empty bed not another factors. for elimination of effect of scale use for sedation preparation, scale group is considered. Nursing in scale group based on physician order inject sedation drugs similar to routine group but scale is available for them to use. In this group, sedation score of each patients measured by Richmond scale every 3 hours and then based on score, and physician order, nurse inject sedation drug. Researcher educate Richmond scale to nurses of wards to nurses inject sedation drugs based on scale. Also scale is attaching to wall of patients rooms for observation. Richmond scores of patients document by nurses every 3h. Allocation of patients in this group is randomly and based on inclusion criteria. in this group similar to control group physician order is base for drug prescription and followup is continued till attachgment to ventilator or having endotracheal tube, and if done tracheostomy, followup terminate. Intervention 2: at first for determination of routine method effect on outcomes of mechanical ventilation, patients who have inclusion criteria are selected as samples and is done parameteres. at current ways that is done for sadation of patients is including prescription of sedation drugs according to type, dosage, and injection via PRN method as physician order. in routine method, we use of fentanyl and morphine and midazolam via blous and PRN. these drugs is used without any scales and evaluation. nurses in this method have not any scheduled program for drug injection and decision making are based on intuition. followup duration for patients in this group is untill having endotracheal tube and attachment to ventilator. but if patient undergo tracheostomy followup terminate. drugs dosage for this group is based on physician order and prescription by nurses. Intervention 3: In protocol group, at first agitation score of each patient measured by nurse, and if Richmond score of patient was more than zero, ventilators and other devices are assessed by nurse, and after correction of changeable causes (position …), environment improvement, giving verbal confidence to patient, Midazolam and Fentanyl are inject. Injection of these drugs is bolus at first and based on calculated dosage for weight and time duration for each drugs in protocol that continue till obtaining relaxation namely Richmond score between 0 to -1. Then continuous infusion of drug based on patient's weight is started. Thereafter control of patient's sedation level is evaluated by nurse at q3h, and based on obtained score, continue drug dose with increase, decrease or unchanged. Goal is obtaining Richmond score between 0 to -1. If necessary to decrease or increase of drug dosage, it is done by increasing or decreasing 25% to primary dosage of drug by nurses (as infusion). Richmond scores are document q3h by nurses. Protocol was designed based on research results from 2005 to current that is according to sedation level evaluation by assessment tools with sedation prescription for achieving to optimal level of sedation that is leading to improved clinical outcomes and improved quality of treatment with sedation. This protocol is confirmed by ward physician. Education of protocol to ward nursed is done by researcher. Also protocol is attached to wall of patient's rooms for observation. Richmond scores for each patient are documented by nurses. Allocation of samples to each group is based on inclusion criteria and randomly. Drugs is including: 1) midazolam Bolus 0.05 mg/kg q5m untill richmond score 0 t0 -1 and after continous infusion of midazolam 0.03 mg/kg/hr. 2) Fentanyl bolus 1/5 microgram/kg q10m till richmond score 0 to -1 and after continous infusion of fentanyl 0.7 microgram/kg/hr. follow up duration is similar to routine and scale group till attachment to ventilator and having endotracheal tube. and if done tracheostomy for patient followup is terminate.
public Babamohamadi, Hassan
Semnan, University of Medical Sciences, Nursing and Allied Health Faculty
Semnan Iran (Islamic Republic of) 3513138111 +98 23 1335 4190 babamohamadi@sem-ums.ac.ir Semnan University of Medical Sciences scientific Babamohamadi, Hassan
Semnan, University of Medical Sciences, Nursing and Allied Health Faculty
Semnan Iran (Islamic Republic of) 3513138111 +98 23 1335 4190 babamohamadi@sem-ums.ac.ir Semnan University of Medical Sciences Iran (Islamic Republic of) inclusion criteria: age above18y and under 65y; under mechanical ventilation with Positive pressure; attachment to mechanical ventilation more than 48h; need to sedative drugs in treatment plan. exclusion criteria: Tracheostomy; weaning before 24h; using neuromuscular blocker drugs; after CPR; severe hearing loss; pripheral nervous system disorders; addiction; pneumonia before 48h of attchment to mechanical ventilation. 18 years 65 years Both j18 j70.9 y65.8 z51.8 Pneumonia, organism unspecified Respiratory conditions due to unspecified external agent Other specified misadventures during surgical and medical care Other specified medical care Treatment - Drugs Treatment - Drugs Treatment - Drugs after finishing control group sampling, randomly in one section of ICU ward of Alzahra Hospital of Isfahan implement scale and in another part protocol. it is noticeable that selection of patients are based on empty bed not another factors. for elimination of effect of scale use for sedation preparation, scale group is considered. Nursing in scale group based on physician order inject sedation drugs similar to routine group but scale is available for them to use. In this group, sedation score of each patients measured by Richmond scale every 3 hours and then based on score, and physician order, nurse inject sedation drug. Researcher educate Richmond scale to nurses of wards to nurses inject sedation drugs based on scale. Also scale is attaching to wall of patients rooms for observation. Richmond scores of patients document by nurses every 3h. Allocation of patients in this group is randomly and based on inclusion criteria. in this group similar to control group physician order is base for drug prescription and followup is continued till attachgment to ventilator or having endotracheal tube, and if done tracheostomy, followup terminate. at first for determination of routine method effect on outcomes of mechanical ventilation, patients who have inclusion criteria are selected as samples and is done parameteres. at current ways that is done for sadation of patients is including prescription of sedation drugs according to type, dosage, and injection via PRN method as physician order. in routine method, we use of fentanyl and morphine and midazolam via blous and PRN. these drugs is used without any scales and evaluation. nurses in this method have not any scheduled program for drug injection and decision making are based on intuition. followup duration for patients in this group is untill having endotracheal tube and attachment to ventilator. but if patient undergo tracheostomy followup terminate. drugs dosage for this group is based on physician order and prescription by nurses. In protocol group, at first agitation score of each patient measured by nurse, and if Richmond score of patient was more than zero, ventilators and other devices are assessed by nurse, and after correction of changeable causes (position …), environment improvement, giving verbal confidence to patient, Midazolam and Fentanyl are inject. Injection of these drugs is bolus at first and based on calculated dosage for weight and time duration for each drugs in protocol that continue till obtaining relaxation namely Richmond score between 0 to -1. Then continuous infusion of drug based on patient's weight is started. Thereafter control of patient's sedation level is evaluated by nurse at q3h, and based on obtained score, continue drug dose with increase, decrease or unchanged. Goal is obtaining Richmond score between 0 to -1. If necessary to decrease or increase of drug dosage, it is done by increasing or decreasing 25% to primary dosage of drug by nurses (as infusion). Richmond scores are document q3h by nurses. Protocol was designed based on research results from 2005 to current that is according to sedation level evaluation by assessment tools with sedation prescription for achieving to optimal level of sedation that is leading to improved clinical outcomes and improved quality of treatment with sedation. This protocol is confirmed by ward physician. Education of protocol to ward nursed is done by researcher. Also protocol is attached to wall of patient's rooms for observation. Richmond scores for each patient are documented by nurses. Allocation of samples to each group is based on inclusion criteria and randomly. Drugs is including: 1) midazolam Bolus 0.05 mg/kg q5m untill richmond score 0 t0 -1 and after continous infusion of midazolam 0.03 mg/kg/hr. 2) Fentanyl bolus 1/5 microgram/kg q10m till richmond score 0 to -1 and after continous infusion of fentanyl 0.7 microgram/kg/hr. follow up duration is similar to routine and scale group till attachment to ventilator and having endotracheal tube. and if done tracheostomy for patient followup is terminate. Clinical pneumonia due to mechanical ventilation. Timepoint: first and fourth day of admission. Method of measurement: physician diagnosis. Mechanical ventilation duration. Timepoint: hour. Method of measurement: from attchment to ventilator until weaning time. Hospitalization time in ICU. Timepoint: hour. Method of measurement: from admission in ICU until discharge time. Intra tracheal tube duration. Timepoint: hour. Method of measurement: from insertion tracheal tube until exiting. Mechanical ventilation modes. Timepoint: hour. Method of measurement: including Spont, SIMV, Bilevel. Semnan University of Medical Sciences Approved 2012-06-19 Semnan University of Medical Sciences Semnan- Basidj Bolv- Central deputy of Semnan University of Medical Sciences- Research and Technology deputy Semnan Iran (Islamic Republic of)