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IRCT20190219042766N1 IRCT 2019-09-28 Esfahan University of Medical Sciences Extubation method on extubation failure and mechanical ventilation duration Comparision of two methods according to clinical judgment and protocol in extubation on mechanical ventilation duration and extubation failure in children 2019-06-27 anticipated 68 Complete https://irct.ir/trial/37671 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization with two numbers in each block. N/A Extubation method. Intervention 1: In intervention group,the readiness criteria included the following are evaluated: recovery or eliminating of their underlying causes for respiratory failure and intubation, T<38.5 ºC, HB> 8, ability to swallow secretions, having gag or cough reflexes during suctioning the secretions, having an acceptable level of consciousness, i.e. GCS score≥8 after discontinuing sedations and analgesics, correction of electrolytes, absence of new findings in the chest X-ray, no needs for increasing the settings of the ventilator over the previous 24 hours, the total discontinuation of sedations and analgesics in at least the previous six hours, no needs for vasoactive agents, an acceptable arterial-blood gas and air exchange with StO2>94% despite FiO2<40, PIP<20 and PEEP<5.If they meet all criteria, the ventilator settings are set as follows: Mode: Spont/PSV, PEEP≤5, FiO2≤40, PS according to ET size (3-3.5:10, 4-4.5:8, ≥5:6). The SBT failure is confirmed in case at least two of the following conditions are observed during the intervention: respiratory rate being outside the normal range by age, i.e. tachypnea or bradypnea, respiratory distress, VTe<5 ml/kg, SatO2<90%, hypotension based on PALS guidelines or an over 20% increase in blood pressure, impaired consciousness associated with hypoventilation, heart rate outside the normal range by age, i.e. tachycardia and bradycardia, Pco2>55 mmHg or an increase in Pco2 by at least 10mmHg in patients with chronic pulmonary disease in the final arterial-blood gas test. If the test failed, the parameters and mode of the ventilator are set as before the test, and if the clinical criteria are met as described, the test is repeated 24 hours later.Endotracheal tube is immediately extracted if the test is successful, and the patient is provided with a non-rebreathing face mask with a 10-15 l/min flow, and undergo100% oxygen therapy. Arterial-blood gas test is performed two hours after extubation. Extubation failure is confirmed in case at least two of the following symptoms emerged within two days of extubation: respiratory distress, hypoxia with SatO2<90%, respiratory rate outside the normal range by age, i.e. tachypnea or bradypnea , apnea>20 seconds, hypotension based on PALS guidelines or an over 20% increase in blood pressure, impaired consciousness associated with hypoventilation, heart rate outside the normal range by age, i.e. tachycardia and bradycardia, Pco2>55 mmHg or an increase in Pco2 by at least 10mmHg in patients with chronic pulmonary disease accompanied by PH<7.3 and symptoms of upper airway obstruction. In case of the absence of contraindications for NIMV, Bi-level positive airway pressure (BiPAP) is applied with minimum settings as EPAP:5 and IPAP:8-10, and tittered up to EPAP:8-10 and IPAP:5-22 and until clinical and laboratory symptoms of respiratory failure disappear. The patient is reintubated if respiratory failure symptoms persist after two hours of monitoring. Intervention 2: In control group ,The attendant of pediatric or anesthesiology by ICU fellowship decides on ventilator settings and respiratory support reduction and extubation according to the results of arterial-blood gas tests performed at least once a day and based on the patient's clinical conditions, including eliminating the causes of intubation, appropriate ventilation and oxygenation and stable vital signs.The post-extubation oxygen supply method, the criteria of extubation failure and NIMV and reintubation protocols are as same as the intervention group. No - There is not a plan to make this available Justification or reason for not sharing IPD is Making decision after doing this study.
public Dr Atefeh Sadeghizadeh
Kilometer 10 Imam Khomeini Avenue- Imam Hussein Hospital
Isfahan Iran (Islamic Republic of) ۸۱۹۵۱۶۳۳۸۱ +98 31 3386 6266 a.sadeghizadeh@gmail.com Esfahan University of Medical Sciences scientific Dr atefeh Sadeghizadeh
Kilometer 10 Imam khomeini Avenue,Imam Hussein Hospital
Isfahan Iran (Islamic Republic of) ۸۱۹۵۱۶۳۳۸۱ +98 31 3386 6266 a.sadeghizadeh@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) All infants and children ،aged between 1 month to 14 years، admitted in PICU Patients have been receiving MV above 12 hours 1 month 14 years Both Intubation due to upper airway obstruction (UAO) neuromuscular disease tracheostomy chronic MV use cyanotic congenital heart disease primary pulmonary hypertension. Treatment - Other N/A In intervention group,the readiness criteria included the following are evaluated: recovery or eliminating of their underlying causes for respiratory failure and intubation, T<38.5 ºC, HB> 8, ability to swallow secretions, having gag or cough reflexes during suctioning the secretions, having an acceptable level of consciousness, i.e. GCS score≥8 after discontinuing sedations and analgesics, correction of electrolytes, absence of new findings in the chest X-ray, no needs for increasing the settings of the ventilator over the previous 24 hours, the total discontinuation of sedations and analgesics in at least the previous six hours, no needs for vasoactive agents, an acceptable arterial-blood gas and air exchange with StO2>94% despite FiO2<40, PIP<20 and PEEP<5.If they meet all criteria, the ventilator settings are set as follows: Mode: Spont/PSV, PEEP≤5, FiO2≤40, PS according to ET size (3-3.5:10, 4-4.5:8, ≥5:6). The SBT failure is confirmed in case at least two of the following conditions are observed during the intervention: respiratory rate being outside the normal range by age, i.e. tachypnea or bradypnea, respiratory distress, VTe<5 ml/kg, SatO2<90%, hypotension based on PALS guidelines or an over 20% increase in blood pressure, impaired consciousness associated with hypoventilation, heart rate outside the normal range by age, i.e. tachycardia and bradycardia, Pco2>55 mmHg or an increase in Pco2 by at least 10mmHg in patients with chronic pulmonary disease in the final arterial-blood gas test. If the test failed, the parameters and mode of the ventilator are set as before the test, and if the clinical criteria are met as described, the test is repeated 24 hours later.Endotracheal tube is immediately extracted if the test is successful, and the patient is provided with a non-rebreathing face mask with a 10-15 l/min flow, and undergo100% oxygen therapy. Arterial-blood gas test is performed two hours after extubation. Extubation failure is confirmed in case at least two of the following symptoms emerged within two days of extubation: respiratory distress, hypoxia with SatO2<90%, respiratory rate outside the normal range by age, i.e. tachypnea or bradypnea , apnea>20 seconds, hypotension based on PALS guidelines or an over 20% increase in blood pressure, impaired consciousness associated with hypoventilation, heart rate outside the normal range by age, i.e. tachycardia and bradycardia, Pco2>55 mmHg or an increase in Pco2 by at least 10mmHg in patients with chronic pulmonary disease accompanied by PH<7.3 and symptoms of upper airway obstruction. In case of the absence of contraindications for NIMV, Bi-level positive airway pressure (BiPAP) is applied with minimum settings as EPAP:5 and IPAP:8-10, and tittered up to EPAP:8-10 and IPAP:5-22 and until clinical and laboratory symptoms of respiratory failure disappear. The patient is reintubated if respiratory failure symptoms persist after two hours of monitoring In control group ,The attendant of pediatric or anesthesiology by ICU fellowship decides on ventilator settings and respiratory support reduction and extubation according to the results of arterial-blood gas tests performed at least once a day and based on the patient's clinical conditions, including eliminating the causes of intubation, appropriate ventilation and oxygenation and stable vital signs.The post-extubation oxygen supply method, the criteria of extubation failure and NIMV and reintubation protocols are as same as the intervention group. Mechanical ventilation duration. Timepoint: 9 months. Method of measurement: Hospital admission file. Extubation failure. Timepoint: 9 months. Method of measurement: Hospital admission file. Length of hospital stay. Timepoint: 9 months. Method of measurement: Hospital admission file. Length of PICU stay. Timepoint: 9 months. Method of measurement: Hospital admission file. Mortality in PICU. Timepoint: 9 months. Method of measurement: Hospital admission file. Esfahan University of Medical Sciences Approved 2019-02-03 Ethics committee of Isfahan university of medical sciences Hezarjerib Avenue Isfahan Isfehan Iran (Islamic Republic of)