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IRCT20190917044792N1 IRCT 2019-11-15 Sabzevar University of Medical Sciences The effect of using high-flow nasal cannula after early extubation respiratory after children's heart surgery The effect of using high-flow nasal cannula after early extubation On respiratory parameters and pulmonary complications after children's heart surgery 2019-10-23 anticipated 110 Complete https://irct.ir/trial/42209 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple random method using statistical software. N/A Postoperative pulmonary complications. Intervention 1: Intervention group: From the Fisher & Paykel MR850 Series we select two types of nasal cannula based on baby weight and body mass index: nasal cannula that offers maximal flow rate of 8 l / min for infants less than 4 kg and nasal cannula That delivers a maximum flow of 20 l / min for children> 4 kg.And so when applied to an HFNC device, the gas mixture is set at 2 liters / kg for the first ten kilos and half liters / kg thereafter at 40% fiO2. Intervention 2: Control group: Routinely receive normal nasal cannula section with Lit / min6 flow which produces 40% fio2. Yes - There is a plan to make this available What will be shared: Part of the data, such as information about the main outcome or the like, can be shared. When: Start of access period 6 months after printing results To whom: Researchers and students will be available at academic and scientific institutions Conditions: Nursing care for children undergoing heart surgery Where to obtain: Farzaneh Enayati Email address: enayatifarzaneh26@gmail.com How to obtain: Almost 1 month after sending the request Comments:
public Farzaneh Enayati
No. 3 , Elahieh 32,Elahieh Boulevard،Mashhad
Mashhad Iran (Islamic Republic of) 9189864398 +98 51 3501 6559 enayatifarzaneh26@gmail.com Sabzevar University of Medical Sciences scientific Mojgan Ansari
Campus of Sabzevar University of Medical Sciences، Tohid Township,Sabzevar
Sabzevar Iran (Islamic Republic of) 91898 64398 009851444018345 mojganansari01@gmail.com Sabzevar University of Medical Sciences Iran (Islamic Republic of) Children older than one month and less than two years old Children with congenital heart problems based on RACHS 2 or 3 criteria Full conscious 1 month 24 months Both History of renal Disease History of pulmonary disease History of brain disease History of Endocrine Disease Preoperative infection history Pre-operative mechanical ventilation Moderate to severe anemia (hemoglobin less than 10 mg / dL) Severe electrolyte and acid-base disturbances (pH lower than 7.30 and greater than 7.50) Malnutrition T81.9 Unspecified complication of procedure Other Other Intervention group: From the Fisher & Paykel MR850 Series we select two types of nasal cannula based on baby weight and body mass index: nasal cannula that offers maximal flow rate of 8 l / min for infants less than 4 kg and nasal cannula That delivers a maximum flow of 20 l / min for children> 4 kg.And so when applied to an HFNC device, the gas mixture is set at 2 liters / kg for the first ten kilos and half liters / kg thereafter at 40% fiO2. Control group: Routinely receive normal nasal cannula section with Lit / min6 flow which produces 40% fio2 Atelectasis is the sleeping or closing of the alveoli. Timepoint: Evaluation of atelectasis is monitored and recorded daily using plain chest x-ray on arrival at the ICU as well as by ultrasound. Method of measurement: Used for the evaluation of pulmonary complications, including atelectasis, a portable SonoSite EDGE ultrasound system with a pediatric size probe. Arterial Oxygen Pressure: Oxygen pressure (Po2) is an indirect measure of arterial blood oxygen content and its normal range is between 80-100 mmHg. Timepoint: On admission to the ICU and after 6 hours in the ICU during mechanical ventilation and before extubation and immediately after extubation and at 1, 2, 6, 12, 24 and 36 hours after HFNC or conventional oxygen therapy, respectively.will be measured. Method of measurement: Arterial blood pressure was measured using an arterial blood sample and a GEM3000 blood gas analyzer. Arterial carbon dioxide pressure: The relative pressure of CO2 in arterial blood is called Pco2, which is a sign of ventilation. Normal body Pco2 ranges from 35 to 45 mm Hg in adults and 41 to 26 mm Hg in children younger than 2 years. Timepoint: On admission to the ICU and after 6 hours in the ICU during mechanical ventilation and before extubation and immediately after extubation and at 1, 2, 6, 12, 24 and 36 hours after HFNC or conventional oxygen therapy, respectively.will be measured. Method of measurement: Arterial blood pressure was measured using an arterial blood sample and a GEM3000 blood gas analyzer. PAO2 / FIO2 Ratio: The ratio of arterial oxygen pressure and tail oxygen content, a comparison between the level of oxygen in the blood and the oxygen concentration that breathes. Normal PaO2 content: FiO2 = 100 mmHg / 500 0.2 0.21. Timepoint: On admission to the ICU and after 6 hours in the ICU during mechanical ventilation and before extubation and immediately after extubation and at 1, 2, 6, 12, 24 and 36 hours after HFNC or conventional oxygen therapy, respectively.will be measured. Method of measurement: Arterial blood samples and GEM3000 blood gas analyzer are used. Re-intubation: Inability to spontaneously breathe after removal of the artificial airway, leading to the need for endotracheal intubation over a specified period of time: either within 24-72 hours or up to 7 days after the first extubation. Timepoint: In this study, 24 to 72 hours after the first extubation is considered to assess the need for re-intubation. Method of measurement: According to the information recorded in the patient's file. Respiratory insufficiency: A sudden and dangerous impairment of gas exchange by the lungs, with the lungs failing to balance oxygen and carbon dioxide, with arterial oxygen pressure less than 50 mm Hg and arterial carbon dioxide pressure greater than 50 mm Hg and arterial pH are less than 7.35. Timepoint: Case studiesSigns and symptoms are constantly monitored for respiratory failure during the study. Method of measurement: According to respiratory parameters and arterial blood sample and analyzed with GEM3000 blood gas device. Pleural effusion: The fluid accumulates more than 15 cc in the lateral cavity. Timepoint: Evaluation of pleural effusion is monitored and recorded daily using plain chest x-ray and ultrasound. Method of measurement: To evaluate pulmonary complications such as pleural effusionA Portable SonoSite EDGE portable ultrasound system with a baby size probe is used. Sabzevar University of Medical Sciences Approved 2019-10-06 Ethics Committee of Sabzevar University of Medical Sciences Research No. 3 ،Elahieh32 ،Elahieh Blv، Misaq highway،Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)