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IRCT20180714040466N5 IRCT 2023-10-06 Zahedan University of Medical Sciences The effect of routine chest physiotherapy and expiratory techniques on oxygenation and expiratory volume of preterm infants The effect of routine chest physiotherapy and expiratory techniques on oxygenation and expiratory volume of preterm infants with respiratory distress syndrome 2023-11-22 anticipated 30 Complete https://irct.ir/trial/71526 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization as follows: Based on the number of patients in each group, the particular sort of treatment (routine chest physiotherapy group or expiratory techniques with routine chest physiotherapy group) is written on a piece of paper. Each paper is placed in a sealed envelope. One envelope will be chosen randomly by the therapist at the first session of the patient treatment and the patient's treatment technique is selected based on that .If any of the patients is omitted from the study, one envelope related to the excluded patient treatment group will be replaced and they will mixed again. N/A Respiratory distress syndrome of newborn. Intervention 1: Intervention group: A group are the neonatals diagnosed with respiratory distress syndrome who will be admitted and intubated in the neonatal intensive care unit of Afzalipour hospital in Kerman will be examined if they meet the conditions for entering the study. Diagnosis of the syndrome is based on history, examination and clinical symptoms including respiratory rate, breathing pattern, paraclinical including arterial blood gases, (ABG) radiology and also the use of ventilator by the doctor. First, the work steps are fully will be explained to the families of premature newborns, and the consent form and questionnaire will be completed by their families. Then the newborns are randomly placed in this group and routine physiotherapy techniques including chest vibration, percussion, pastural drainage and exhalation techniques including prolonged slow expiratory, expiratory flow increased, lung squeezing technique and vojta twice a day with a time interval of eight hours, five days while the patient's stomach is empty one hour before to prevent aspiration, it will be done in two shifts in the morning and in the evening according to the doctor's order. The evaluated variables will be recorded before doing the physiotherapy and then fifteen minutes after doing the respiratory physiotherapy, which is displayed by the ventilator device. Intervention 2: Routine group: B group are the neonatals diagnosed with respiratory distress syndrome who will be admitted and intubated in the neonatal intensive care unit of Afzalipour hospital in Kerman will be examined if they meet the conditions for entering the study. Diagnosis of the syndrome is based on history, examination and clinical symptoms including respiratory rate, breathing pattern, paraclinical including arterial blood gases (ABG), radiology and also the use of ventilator by the doctor. First, the work steps fully will be explained to the families of premature newborns, and the consent form and questionnaire will be completed by their families. Then the newborns are randomly placed in this group with routine physiotherapy techniques including: chest vibration, percussion and postural drainage on them twice a day with a time interval of eight hours, five days while the patient's stomach is empty one hour before to prevent aspiration, it will be done in two shifts in the morning and in the evening according to the doctor's order. The evaluated variables will be recorded before doing the physiotherapy and then fifteen minutes after doing the respiratory physiotherapy, which is displayed by the ventilator device. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Fateme Ghiasi
Khatam al anbia Hosp, Jame jam Blvd
Zahedan Iran (Islamic Republic of) 9815733169 +98 54 3322 0501 f_ghiasi_p@zaums.ac.ir Zahedan University of Medical Sciences scientific Fateme Ghiasi
Khatam al anbia Hosp, Jame jam Blvd
Zahedan Iran (Islamic Republic of) 9815733169 +98 54 3322 0501 f_ghiasi_p@zaums.ac.ir Zahedan University of Medical Sciences Iran (Islamic Republic of) Premature infants aged between 32-37 weeks of pregnancy RDS diagnosed by a specialist doctor Be in the first 28 days of birth Be intubated She or he does not have a known heart or neurological problem or a candidate for surgery The neonatal girl or boy 1 day 28 days Both Unwillingness to enter the study P22.0 Respiratory distress syndrome of newborn Rehabilitation Rehabilitation Intervention group: A group are the neonatals diagnosed with respiratory distress syndrome who will be admitted and intubated in the neonatal intensive care unit of Afzalipour hospital in Kerman will be examined if they meet the conditions for entering the study. Diagnosis of the syndrome is based on history, examination and clinical symptoms including respiratory rate, breathing pattern, paraclinical including arterial blood gases, (ABG) radiology and also the use of ventilator by the doctor. First, the work steps are fully will be explained to the families of premature newborns, and the consent form and questionnaire will be completed by their families. Then the newborns are randomly placed in this group and routine physiotherapy techniques including chest vibration, percussion, pastural drainage and exhalation techniques including prolonged slow expiratory, expiratory flow increased, lung squeezing technique and vojta twice a day with a time interval of eight hours, five days while the patient's stomach is empty one hour before to prevent aspiration, it will be done in two shifts in the morning and in the evening according to the doctor's order. The evaluated variables will be recorded before doing the physiotherapy and then fifteen minutes after doing the respiratory physiotherapy, which is displayed by the ventilator device. Routine group: B group are the neonatals diagnosed with respiratory distress syndrome who will be admitted and intubated in the neonatal intensive care unit of Afzalipour hospital in Kerman will be examined if they meet the conditions for entering the study. Diagnosis of the syndrome is based on history, examination and clinical symptoms including respiratory rate, breathing pattern, paraclinical including arterial blood gases (ABG), radiology and also the use of ventilator by the doctor. First, the work steps fully will be explained to the families of premature newborns, and the consent form and questionnaire will be completed by their families. Then the newborns are randomly placed in this group with routine physiotherapy techniques including: chest vibration, percussion and postural drainage on them twice a day with a time interval of eight hours, five days while the patient's stomach is empty one hour before to prevent aspiration, it will be done in two shifts in the morning and in the evening according to the doctor's order. The evaluated variables will be recorded before doing the physiotherapy and then fifteen minutes after doing the respiratory physiotherapy, which is displayed by the ventilator device. Expiratory volume (Vte). Timepoint: Before physiotherapy and 15 minutes after physiotherapy. Method of measurement: Expiratory volume recorded on the ventilator. Oxygen saturation of hemoglobin (O2sat). Timepoint: Before physiotherapy and 15 minutes after physiotherapy. Method of measurement: The percentage recorded on the monitor by the pulse oximeter. Number of breaths per minute. Timepoint: Before physiotherapy and 15 minutes after physiotherapy. Method of measurement: The rate of breaths recorded on the ventilator. The fraction of inspired oxygen (Fio2). Timepoint: Before physiotherapy and 15 minutes after physiotherapy. Method of measurement: The percentage recorded by the ventilator. Mean airway pressure (MAP). Timepoint: Before physiotherapy and 15 minutes after physiotherapy. Method of measurement: The number recorded on the ventilator. Positive end expiratory pressure (PEEP). Timepoint: Before physiotherapy and 15 minutes after physiotherapy. Method of measurement: The number recorded on the ventilator. Peak inspiratory pressure. Timepoint: The number recorded on the ventilator. Method of measurement: The number recorded on the ventilator. Zahedan University of Medical Sciences Approved 2023-08-20 Ethics Committee of Zahedan University of Medical Sciences Dr. Hesabi Street Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)