|Year : 2019 | Volume
| Issue : 4 | Page : 227-231
Comparative study of the effect of the administration of surfactant through a thin endotracheal catheter into trachea during spontaneous breathing with intubation (intubation-surfactant-extubation method)
Hassan Boskabadi1, Gholamali Maamouri1, Reza Gharaei Jomeh2, Maryam Zakerihamidi3
1 Department of Pediatrics, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
2 Department of Pediatrics, School of Medicine, Birjand University of Medical Sciences, Birjand, Iran
3 Department of Midwifery, School of Medical Sciences, Islamic Azad University, Tonekabon Branch, Tonekabon, Iran
|Date of Submission||26-Mar-2019|
|Date of Decision||06-Apr-2019|
|Date of Acceptance||29-Apr-2019|
|Date of Web Publication||04-Oct-2019|
Dr. Reza Gharaei Jomeh
Assistant Professor, Faculty Member of School of Medicine, Birjand University of Medical Sciences, Birjand
Source of Support: None, Conflict of Interest: None
Introduction: The main reason for respiratory distress syndrome (RDS) is surfactant deficiency. One of the methods for surfactant administration is through a thin endotracheal catheter (TEC) during the spontaneous breathing of an infant. To identify the clinical effects of this method, we decided to compare the effect of surfactant administration through a TEC during spontaneous breathing through the intubation-surfactant-extubation (INSURE) method. Methodology: In a single-blind clinical trial, we randomly divided 40 premature infants with a gestational age of <32 weeks and birth weight of <1500 g suffering from RDS who needed surfactant administration, into the two groups of intervention (TEC) and control (INSURE). The treatment results were compared in the two groups in terms of the frequency and duration of mechanical ventilation requirement, duration of nasal continuous positive airway pressure (NCPAP) requirement, duration of infants' stay in neonatal intensive care unit, and side effects such as pulmonary hemorrhage, frequency and severity of intraventricular hemorrhage of the brain, and also death at 28 days of age. Results: The infants of both groups did not significantly differ in terms of gender, mode of delivery, Apgar score at 1 and 5 min, gestational age, and birth weight (P > 0.05). The mechanical ventilation requirement in the infants of the control group was significantly higher compared to the intervention group (P = 0.027). The duration of NCPAP requirement and duration of hospitalization in the groups did not significantly differ (P > 0.05). Conclusion: Based on our results, the TEC method decreases mechanical ventilation requirement, but NCPAP requirement and duration of stay did not differ from the normal method, therefore, TEC can be an acceptable alternative to INSURE.
Keywords: Intubation-surfactant-extubation, premature infant, respiratory distress syndrome, surfactant, thin endotracheal catheter
|How to cite this article:|
Boskabadi H, Maamouri G, Gharaei Jomeh R, Zakerihamidi M. Comparative study of the effect of the administration of surfactant through a thin endotracheal catheter into trachea during spontaneous breathing with intubation (intubation-surfactant-extubation method). J Clin Neonatol 2019;8:227-31
|How to cite this URL:|
Boskabadi H, Maamouri G, Gharaei Jomeh R, Zakerihamidi M. Comparative study of the effect of the administration of surfactant through a thin endotracheal catheter into trachea during spontaneous breathing with intubation (intubation-surfactant-extubation method). J Clin Neonatol [serial online] 2019 [cited 2020 Sep 24];8:227-31. Available from: http://www.jcnonweb.com/text.asp?2019/8/4/227/268584
| Introduction|| |
Respiratory distress syndrome (RDS) is one of the most common respiratory diseases as well as the major cause of mortality and morbidity and hospitalization of premature infants. The main cause of these diseases is surfactant deficiency, and it has the following clinical symptoms: tachypnea, respiratory distress, cyanosis, grunting, and increased oxygen need. These symptoms start at birth, but in older premature infants, they may not be diagnosed until several hours after birth., The discovery of the key role of surfactant in the pathophysiology of RDS by Avery and Mead in 1959, made researchers think about administering surfactant aerosol for premature infants suffering from RDS. In the early 80s, Fujiwara et al. administered a mixture of natural and artificial surfactant for preterm infants with RDS and observed a significant decrease in consumed oxygen and ventilator pressures. Currently, the establishment of nasal continuous positive airway pressure (NCPAP) and administration of surfactant are considered as the primary and most important therapeutic intervention in RDS infants which of course, the common method currently is the intubation-surfactant-extubation (INSURE) for the administration of surfactant.
However, this is an aggressive treatment because it requires endotracheal intubation for surfactant administration. Side effects during administration of surfactant include bradycardia, hypoxia, and hypotension. In the INSURE method, an infant is intubated for surfactant administration and after the administration, he is extubated. In this method, long-term mechanical ventilation side effects are prevented, but there will still be needed for intubation, and therefore, potential traumatic side effects to the glottis and airway during intubation may happen. Regarding pulmonary damage and mechanical ventilation, animal studies show that within a time period as short as 5 min since the start of the complementary ventilation, in lungs lacking surfactant, necrosis, and destruction of epithelial bronchioles develop. To enjoy the benefits of surfactants while limiting the side effects of tracheal intubation, new methods have been invented for surfactant administration during which, the surfactant is administrated without tracheal intubation. These methods are called minimally invasive surfactant therapy (MIST). One of these methods is the administration of surfactant through a thin endotracheal catheter (TEC) during an infant's spontaneous breathing which may decrease the side effects of surfactant. Therefore, in a single-blind clinical trial, we compared infants receiving surfactant through a TEC during spontaneous breathing and infants receiving surfactant through a tracheal tube.
| Methodology|| |
In a clinical trial, we studied 40 infants with RDS hospitalized in the Neonatal Intensive Care Unit (NICU) of the Ghaem Hospital of Mashhad, Iran, during the years of 2013–2015. This study was confirmed by the Ethics Committee of the Mashhad Medical University, and the consent of the parents of the infants was obtained before inclusion into the study. Premature infants with a gestational age of <32 weeks and birth weight of <1500 g with RDS who needed surfactant administration, were included into the study, and infants with a congenital anomaly and underlying diseases (such as congenital infection, asphyxia, and congenital heart disease) were excluded from it.
In this study, infants with RDS at birth were resuscitated according to the 2011 neonatal resuscitation clinical guide and transferred to the NICU. The diagnosis of RDS was performed based on clinical practice, and radiography was given by neonatal' fellowship.
Newborns from the operating room and delivery room were received the same protocols for respiratory stabilization, and in cases needed, since birth, received PEEP (positive end-expiratory pressure) at 5–6 cmH2O levels and during the transfer, CPAP for them continued with a minimum of FiO2. We used NCPAP with 5–8 cmH2O pressure in both groups. All the infants were under treatment with NCPAP before surfactant administration, and in cases where for the establishment of SPO2 of higher than 85%, there was a need for a higher than 40% FiO2, and under the condition of <50–60 mmHg of pCO2 and pH of higher than 7.2, surfactant administration was performed based on the two individual protocols of INSURE or TEC according to the European Consensus 2010 guideline. The administrated surfactant was of CUROSURF type with a dose of 200 mg/kg (2.5cc/kg). The infants who were included in the study were divided into two groups using the random block method. In the intervention group, infants under NCPAP, to receive surfactant, underwent direct laryngoscopy, and a number 5F feeding tube was placed and fixed inside the trachea of the infant and then when the infant was performing spontaneous breathing, he would be administrated 200 mg/kg of surfactant during 1–3 min through the feeding tube, then the feeding tube would be extracted and NCPAP was continued. During the installation of surfactant in the TEC group, the infant was spontaneously breathing and under NCPAP, and we did not worry about installation time in the range of 1–3 min. However, we thought that increasing the time of installation can reduce the likelihood of complications such as desaturation, cough, and reflux of surfactant to the pharynx. In the control group, infants under NCPAP were intubated for surfactant administration and received the same amount of surfactant through the trachea tube, then for 30–60 s, underwent ventilation with bag valve mask and then the trachea tube would be removed and NCPAP would be restarted. The treatment outcomes and also side effects and deaths during administration were measured and registered and then once every 24 h up to 72 h, any need for respiratory support or supplementary oxygen and the mortality rate at 28 days of age in both groups were measured and registered. The data were entered into SPSS version 16 (IBM SPSS Software - Hong Kong S.A.R. of China) after collection. For data evaluation, descriptive statistics (frequencies, proportions, percentages, averages, variance, and standard deviation) and the mean difference test for independent groups (independent sample t-test) and also Chi-square test or Fisher's exact test were used to investigate the relationship between the qualitative variables. In this study, P < 0.05 was considered statistically significant.
| Results|| |
In this study, 40 infants were studied in two groups. 23 infants (57.5%) were male and 17 (42.5%) were female. The mean gestational age was 29.4 ± 1.9 weeks with a 27–32-week spectrum. In 10 cases (25%), the end of the pregnancy occurred through natural childbirth and in 30 cases (75), cesarean was performed. The average 5th-min Apgar score of the study infants was 7.7 ± 1.5. The average birth weight of the infants was 1254.8 ± 219.8. The average weight at discharge from hospital was 1509.3 ± 95.0. The average hospitalization duration at the hospital in the intervention group was 17.2 ± 10.1, and in the control group, it was 21.5 ± 16.6 (P = 0.342). The average time for NCPAP requirement in the intervention group was 1.6 ± 1.2, and in the control group, it was 2.5 ± 3.1 (P = 0.221). In [Table 1], the characteristics of the infants in both groups are compared. Gender did not significantly difference between the two groups (P = 0.523).
We have some minor and transient complications such as cough, mild desaturation, and reflux of surfactant to the pharynx during TEC, which were ceased by reducing the speed of installation. In [Table 2], complications were compared in two groups.
| Discussion|| |
According to the results of this study, using TEC method reduced the need for mechanical ventilation in infants (P = 0.027), and it did not increase the RDS side effects and did not change the duration of NCPAP requirement and duration of hospitalization (P > 0.05).
The infants of two groups of control and intervention were homogenous in terms of the sex, mode of delivery, Apgar score of min 1 and 5, gestational age, and birth weight (P > 0.05) Hence, these factors were not effective in causing differences between the two groups.
The most important finding in our study was the need for reducing ventilation in infants who were receivers of TEC. The Kribs study shows a significant difference in mechanical ventilation between the two groups so that the mechanical ventilation requirement in the TEC group is significantly less than the INSURE group. The duration of mechanical ventilation in Kribs et al. study in the TEC group is also less than the INSURE group statistically. However, in Dargaville et al. study, the duration of mechanical ventilation in both groups does not have a significant difference.
Kanmaz et al. in Turkey showed that the required amount of mechanical ventilation during the first 72 h in the group of surfactant administration through a thin catheter into the trachea during spontaneous breathing was significantly less. In a study, reintubation was required in the two groups of 19.1% of TEC and 17.1% of INSURE that did not show a statistically significant difference. There were no statistically significant differences in terms of mechanical ventilation in infants under the 32 weeks (26% in the TEC method in contrast with 20% in INSURE method).
In Dargaville study, in infants under 32 weeks, the TEC group required less intubation, 26% in contrast with 46%, but the difference between the two was not statistically significant ( P = %94). Hence, the treatment's failure in both methods at least in this study is equal. It seems that not using artificial ventilation in infants has led to preventing lung damage and reduced need for ventilation. In the current study, the average duration of need for NCPAP in infants in the intervention group was about 1 day less than the control group (P = 0.221). In a study in Turley, the duration of need for NCPAP or mechanical ventilation in the group of surfactant administration through a thin catheter into the trachea during spontaneous breathing was significantly shorter. Kribs et al. and Dargaville et al. studies indicate the reduction of the need for oxygen and CPAP duration in the TEC group rather than the INSURE group.,
In our study, the duration of hospitalization time of the infants in the intervention group was about 5 days less than the control group (P = 0.342). In the current study, mortality did not occur in neither INSURE nor intervention groups. In a study in Germany in 2007, Pillekamp showed that mortality in infants through the method of a thin catheter into the trachea during spontaneous breathing had no differences with available reports and surfactant administration is totally possible and with least side effects through it. In Göpel et al. study, there were no significant differences in mortality and severe complications between the method of thin catheter into the trachea during spontaneous breathing and the standard method. The outcome of the result confirms the fact that surfactant administration through thin catheter into the trachea during spontaneous breathing is a low-risk method in premature infants. Kribs et al. study showed that the surfactant administration through thin catheter into the trachea causes the increased likelihood of survival without major complications in premature infants and reduces the long-term disabilities of the infants. In a study in Germany, surfactant, theophylline, doxapram, pain relievers, catecholamines, and dexamethasone were used significantly lower in the intervention group. In our study, despite less need in inotrope and methylxanthines drugs in the intervention group, the frequency of drug requirement in the two groups did not differ (P = 0.749). It can be caused by the differences in the sample sizes because in our study 40 infants, and in the mentioned study, 60 infants were investigated.
In our study, in both groups, one individual got bronchopulmonary dysplasia (BPD), but in Kanmaz et al. study, the occurrence of BPD, in the group in which surfactant administration was performed through TEC during spontaneous breathing, was significantly less than the second group. In a study in Germany, the amount of BPD in the group, in which surfactant administration was performed through TEC during spontaneous breathing, it significantly decreased compared to the group with standard treatment. This difference may be due to a difference in birth age, birth weight, and also smaller sample size in our study. In another study performed in Germany, it was shown that surfactant administration through TEC, does not increase the duration of survival without BPD in premature infants but decreases the amount of major side effects-free survival. Dargaville did not show a significant difference between the two groups, but Kribs et al. in his article showed that the prevalence of BPD in the TEC group is significantly less compared to the INSURE group, but the reason for this decrease is the small ratio of intraventricular hemorrhage in the TEC group and decreased need for mechanical ventilation in the TEC group which is statistically significantly less compared to the INSURE group.
Mortality in Krajewski's study in the group, in which surfactant administration was performed through TEC during spontaneous breathing was 7% which was much lower than the common standard method. In our study, no deaths occurred in either group. It seems that MIST through TEC does not increase mortality in premature infants. Of the most important limitations of the present study, was the lack of an investigation of the long-term effects of these two methods.
| Conclusion|| |
It seems that surfactant administration through TEC during spontaneous breathing can be considered as a MIST which can reduce mechanical ventilation requirements in premature infants without increasing mortalities and side effects.
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Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2]