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IRCT20161124031068N4 IRCT 2020-05-21 Tehran University of Medical Sciences Effect of early mobilization on clinical index in respiratory failure The effect of early mobilization on clinical index in patients with respiratory failure undergoing mechanical ventilation in intensive care units 2020-06-19 anticipated 60 Complete https://irct.ir/trial/47600 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients are divided into control and intervention groups based on the random allocation of double blocking. To do this, the 4 blocks will be selected so that they will belong to the letter A intervention group and the letter B control group. 6 probable states are written on separate cards and one number (from one to six) will be assigned to each card, then the numbers will be written on paper and randomly removed.Until the expected number of samples is completed. In this study, online randomization service (https://www.sealedenvelope.com/simple-randomiser/v1/lists) will be used for randomized block allocation.Allocation concealment will be done using closed envelopes, so that one letter is placed inside each envelope in the specified order, and then the envelope lid will be closed and provided to the researcher. N/A Respiratory Failure. Intervention 1: Intervention group:The intervention designed for this study is a standard 4-level protocol. In the first level, the range of motion of the joints is performed on non-conscious patients and five times on each joint. At the second level, the physiotherapy protocol begins.The patient must answer three of the commands so that the researcher realizes that she/he is ready to enter the next stage.Open your eyes, look at me, open your mouth and stick out your tongue, raise and lower your head, raise your eyebrows when you hear the number 5. If the patient responds to three of the researcher's five requests, his or her condition is appropriate for initiating physiotherapy. When the patient finds sufficient strength and alertness to participate in occupational therapy, he or she will be moved toward two active recipient approaches or active range of motion. They move from level 2 to 4.Measures taken at this level include changing the position every 2 hours, inactive movement of the joint area 3 times a day, and the patient should be placed in a fully sitting position for at least 2 times for 20 minutes.All second-level measures are also performed at levels 3 and 4. The upgrade from level 2 to 3 and from 3 to 4 depends on the score that the patient receives from the MRC criterion in terms of muscular strength in one attempt.A score of 3 out of 5 on the biceps is required to enter level 3 and a score of 3 out of 5 on the quadriceps is required to enter level 4. As the patient progresses, activities should focus on a variety of functions such as sitting on the edge of the bed, getting out of bed, sitting in a balanced position, and pre-starting exercises such as weight transfer on the legs or walking and moving. The implementation of this protocol in the form of interdisciplinary and team work with the cooperation of the members of this team will include a researcher, physiotherapist, physician in charge of ICU and assistant to the ward assistant. Intervention 2: Control group: In this study, the control group will receive the usual care of the ward. The usual care of the section under study in this study is to change the position once or twice in each shift. Yes - There is a plan to make this available What will be shared: All data will be shared. When: starting 6 months after publication. To whom: Researchers working in academic and scientific institutions Conditions: There is no limitation. Where to obtain: Email address. How to obtain: Documents will be sent via email after the work is completed and 6 months after the article is published. Comments:
public Maryam Esmaeili
Central Organization, Tehran University of Medical Sciences, Quds Street, Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6105 4000 esmaeili_m@tums.ac.ir Tehran University of Medical Sciences scientific Maryam Esmaeili
Central Organization, Tehran University of Medical Sciences, Quds Street, Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6105 4000 esmaeili_m@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Passing 48 hours after intubation and mechanical ventilation -3 < RASS < 2 Hemodynamic situation stability PEEP < 8 Fio2 < 60 Spo2 > 89 12 > RR > 30 60 < MAP > 110 18 years 65 years Both Psychosomatic disorder Any mobility disfunction Acute cerebral strock BMI>40 Femour fracture After CPR J96.9 Respiratory failure, unspecified Rehabilitation Rehabilitation Intervention group:The intervention designed for this study is a standard 4-level protocol. In the first level, the range of motion of the joints is performed on non-conscious patients and five times on each joint. At the second level, the physiotherapy protocol begins.The patient must answer three of the commands so that the researcher realizes that she/he is ready to enter the next stage.Open your eyes, look at me, open your mouth and stick out your tongue, raise and lower your head, raise your eyebrows when you hear the number 5. If the patient responds to three of the researcher's five requests, his or her condition is appropriate for initiating physiotherapy. When the patient finds sufficient strength and alertness to participate in occupational therapy, he or she will be moved toward two active recipient approaches or active range of motion. They move from level 2 to 4.Measures taken at this level include changing the position every 2 hours, inactive movement of the joint area 3 times a day, and the patient should be placed in a fully sitting position for at least 2 times for 20 minutes.All second-level measures are also performed at levels 3 and 4. The upgrade from level 2 to 3 and from 3 to 4 depends on the score that the patient receives from the MRC criterion in terms of muscular strength in one attempt.A score of 3 out of 5 on the biceps is required to enter level 3 and a score of 3 out of 5 on the quadriceps is required to enter level 4. As the patient progresses, activities should focus on a variety of functions such as sitting on the edge of the bed, getting out of bed, sitting in a balanced position, and pre-starting exercises such as weight transfer on the legs or walking and moving. The implementation of this protocol in the form of interdisciplinary and team work with the cooperation of the members of this team will include a researcher, physiotherapist, physician in charge of ICU and assistant to the ward assistant. Control group: In this study, the control group will receive the usual care of the ward. The usual care of the section under study in this study is to change the position once or twice in each shift. Respiratory index. Timepoint: Before the start, the end of the first day, the end of the second day, the end of the third day. Method of measurement: Arterial blood gas and monitoring system. Duration of hospital stay in ICU and duration of mechanical ventilation. Timepoint: Mechanical ventilation weaning and discharge from ICU. Method of measurement: Questionnaire. Tehran University of Medical Sciences Approved 2020-04-28 Ethics Committee in Research, School of Nursing and Midwifery, and Faculty of Rehabilitation, Tehran Nosrat St.,Tohid Sq.,Tehran,Iran Tehran Tehran Iran (Islamic Republic of)