The effect of using high-flow nasal cannula after early extubation On respiratory parameters and pulmonary complications after children's heart surgery
Effect of high flow nasal cannula after early extubation on respiratory parameters and pulmonary complications after pediatric heart surgery
Design
A randomized controlled clinical trial with parallel groups Accidental
Settings and conduct
The research is carried out in the pediatric intensive care unit of Imam Reza Research Center of Mashhad.
Which has 10 beds and immediately after children and infants
Corrective heart surgery is admitted here.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
Children older than one month and less than two years old; Children with congenital heart problems based on Risk adjustment for congenital heart surgery (RACHS) score of 2 or 3; Complete vigilance
Exclusion criteria:
History of Kidney Disease; Pulmonary; Cerebral; Endocrine and preoperative infection; Preoperative mechanical ventilation; Malnutrition; Moderate to severe anemia
And severe electrolyte and acid-base disturbances
Intervention groups
Intervention group: Respiratory support with high flow nasal cannula
Control group: Respiratory support conventional oxygen therapy (simple nasal cannula)
Main outcome variables
Atelectasis; Pleural effusion; Respiratory failure; Simple pneumothorax; Need for re-intubation; Arterial oxygen pressure; Arterial carbon dioxide pressure; pao2 / Fio2 ratio
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190917044792N1
Registration date:2019-11-15, 1398/08/24
Registration timing:registered_while_recruiting
Last update:2019-11-15, 1398/08/24
Update count:0
Registration date
2019-11-15, 1398/08/24
Registrant information
Name
Farzaneh Enayati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3501 6559
Email address
enayatif97@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of using high-flow nasal cannula after early extubation On respiratory parameters and pulmonary complications after children's heart surgery
Public title
The effect of using high-flow nasal cannula after early extubation respiratory after children's heart surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 1 month old to 24 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random method using statistical software
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sabzevar University of Medical Sciences Research
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
2
Description
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.
3
Description
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.
4
Description
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.
5
Description
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
6
Description
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.
7
Description
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.
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Other
2
Description
Control group: Routinely receive normal nasal cannula section with Lit / min6 flow which produces 40% fio2
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Cardiac Surgery Intensive Care Unit Imam Reza Research Center of Mashhad