Surfactant administration - Take care technique -Journal club
Journal ClubSurfactant administration via thin catheter during spontaneous breathing : Randomized controlled trial GOPAKUMAR HARIHARAN REGISTRAR , ROYAL HOBART HOSPITAL TASMANIA , AUTRALIA
Presentation Back ground information ( RDS and BPD ) Rationale for study The article and the findings Critical analysis of article Discussion
INTRODUCTION Respiratory distress syndrome (RDS) is the most important cause of mortality and morbidity in preterm infants – surfactant deficiency Conventional management Intubation,mechanical ventilation, and surfactant administration Long term morbidity ( mech vent and oxygen toxicity )– BPD –oxygen Requirement at 36 weeks corrected age
Mechanical ventilation and BPD Few large mechanical breaths may cause lung injury and blunt the effect of subsequent surfactant treatment and increase risk of BPD Efforts to reduce BPD - by restricting mechanical ventilation Surfactant – Successful in treatment of RDS . Does not reduce the incidence of BPD bronchopulmonary dysplasia (BPD)
Ways of reducing mechanical ventilation related to surfactant administration Adverse effects of MV and Oxygen therapy - Trend towards noninvasive methods – early use nasal continuous positive airway pressure (nCPAP) Early nCPAP with early surfactant significantly reduces BPD, MV need, and air leaks compared with nCPAP with late surfactant ( Metanalysis of 6 studies ) Two components of current research – Early surfactant and avoidance of intubation and MV InSurE Technique Minimal invasive surfactant therapy Nasopharyngeal instillation Aerosolised method
AIMTo assess the efficacy and the feasibility of the TakeCare technique andTo compare its short- and long-term effects with theInSurE procedure, especially on the requirement ofintubation and MV in the first 72 hours of life, whichare known to be the major contributing factors forBPD
Inclusion criteria Preterm infants, who were less than 32 weeks - stabilized with nasal continuous positive airway pressure (nCPAP) in the delivery room Patients with signs of RDS and requiring FiO2 more than 0.4 in first 2 hours of life to maintain SpO2 levels between 85% to 92%, were randomized to receive surfactant treatment either by the Take Care or InSurE procedure. Sequentially numbered sealed opaque envelopes stratified by GA (less than 28 weeks and 29 to 32 weeks) - used for randomization.
RDS diagnosis• Need for supplemental oxygen• Tachypnea• Grunting, and intercostal retractions• Confirmed by typical x-ray and blood gas findings
Exclusion criteria Infants with major congenital anomalies No parental consent Who required PPV or intubation in the delivery room Babies not resuscitated by trial investigators
Sample size calculation. Previous experiences with the InSurE technique - 50% of patients required intubation and MV in first 72 hours of life To reduce the need for MV treatment with this new Take Care technique from 50% to 30%, sample size estimated was 100 for each group to yield .80% power.20
Methodology – Surfactant administrationTake care group - Tracheal instillation of 100 mg/kgporactant via 5-F catheter during spontaneousbreathing under nCPAPInSurE - intubated, received positive pressureventilation for 30 seconds after surfactant instillation,and placed on nCPAP immediately.
Take Care technique procedure Used 5F, flexible, sterile nasogastric tube shortened at 33-cm depth from the catheter hub. Desired depths of insertion beyond the vocal cords for preterm infants of 25 to 26, 27 to 28, and 29 to 32 weeks GA were 1.0, 1.5, and 2.0 cm, respectively After catheter placement, the laryngoscope was removed. CPAP support not disrupted throughout the procedureShorter duration (30 to 60 seconds) of a single type of surfactant (poractant a)Administered by only experienced physicians in the NICUShorter catheter length, andno need for forceps during applicationNo premedication or sedation
Procedure Control arterial blood gas samples were taken∼2 hours after the procedure. CPAP pressure was titrated according to work of breathing and oxygen requirement, with SpO2 target of 85% to 92%. If the patient did not respond to treatment or deteriorated after 6 hours of first application (FiO2.0.4, partial pressure of carbon dioxide .60 mm Hg), a second dose of surfactant of 100 mg/kg was repeated and the same procedure was used as during the first surfactant instillation.
Reintubation Maximum acceptable settings were sustained CPAP pressure of beyond 7-cm H2O along with an FiO2 of 0.6. Infants exceeding these limits were intubated, and a further dose of surfactant was given if clinically indicated. Need for MV during the first 72 hours of life in infants who had initially been managed with nCPAP was classified as failure of nCPAP. Other indications for intubation were sustained respiratory acidosis (pH,7.2) and apnea requiring repeated episodes of PPV.
Study population 357 infants Assessed for eligibility254 infants had RDS Participant Population 200 Randomized
RandomizationIntervention Comparison Take Care InsurE 100 100 100
Base line charecteristicsNo significant difference between the groups
Primary OutcomesEffects of the Take Care technique on the need forintubation and MVin the first 72 hours (andthereafter) of life in addition to feasibility of thetechnique.
Secondary outcomes Repeated surfactant therapy Duration of respiratory support Rates of pneumothorax Patent ductus arteriosus requiring medical or surgical treatment Intraventricular hemorrhage (grade .2 according tothe Papille classification) Retinopathy of prematurity greater than stage 2 Necrotizing enterocolitis with Bells stage 2 or greater Length of hospitalization BPD or death.
Observations • Reintubation and MV • Pneumothorax , Duration of respImmediate support, PDA , IVH ,NEC • Chronic lung disease • ROP , Length of hospitalisation , Late Death
Results – PrimaryThe MV requirement ( nCPAP failure in first 72 hoursof life ) Significantly lower in the Take Care group when compared with the InSurE group30% vs 45%,P = .02,RR –0.52, 95%CI – 0.94 to –0.29) (Table 3).
Mean duration of both nCPAP and MV weresignificantly shorter in the Take Care group (P values.006 and .002, respectively).
ResultsPeridosing adverse eventsCoughing and gagging (11%) and bradycardia and desaturation (17%) were recorded as peridosingadverse events in the Take Care group.Failure of first attempt18% of patients in the Take Care group and 10% in the InSurE group ( not statistically significant(P = .07) )Bradycardia and desaturationnot statistically different between groups (18% vs 17%, P = .35).Surfactant reflux during the attemptSignificantly higher in the Take Care group in contrast to the In- SurE group (21% vs 10%, P =.002).Severe apnea and bradycardiaTwelve percent (n = 12) of patients had severe apnea lasting.20 seconds and bradycardia(,100/min) required PPV with a T-piece device during the procedure in the Take Caregroup, whereas all patients in the InSurE group received PPV.
Secondary outcomes – Other Neonatal MorbidiesPatent ductus arteriosus (28% vs 32%),Necrotizing enterocolitis (5% vs 6%),Intraventricular hemorrhage (10% vs 16%), andRetinopathy of prematurity (3% vs 4%) Similar between groups
ConclusionThis single-center prospectiverandomized controlled trialdemonstrated that bolus surfactantadministration during spontaneousbreathing via a thin nasogastrictube, dubbed the Take Caretechnique, was feasible and itsuccessfully reduced the MVrequirement in first 72 hours of life,shortened MV duration, andresulted in a lower BPD rate whencompared with the InSurEtechnique.
Research QuestionDoes take Care Procedure in babies less than 32 weeksof gestation reduce need for mechanical ventilationand thereby incidence of bronchopulmonary dysplasiacompared to babies managed by InSurE technique Hypothesis
Limitation - All infants who Trial profile might have been Randomization eligible for the study - not enrolled because of concern for standardizationOf the babies considered as candidates , a majority of babiesFit into the criteria , which is unlike in clinical practice . ?Population difference
Inclusion CriteriaPatients with signs of RDS, who were under nCPAPtreatment and required fraction of inspired oxygen(FiO2) 0.4 in first 2 hours of life to maintain SpO2levels between 85% to 92%, were randomized toreceive surfactant treatment either by the Take Care orInSurE procedure. Rapid rise of FiO2 to 0.40 at 2 hours ? – Not generally seen in RDS ? Different popluation with associated morbidity or racial difference
successful reduction in BPD rate (10.3%) in comparison with the InSurE (20.2%) method. No significant difference – But difference in CLD ? Other factors? Slow reduction in FiO2 - Usually associated with rapid reduction in FiO2 after surfactant
Chronic Lung disease CLD No CLD Take Care 9 91 100 Insure 17 83 100 26 174 200Mortality 16 % and 13% respectivelyTotal number – 100 . After excluding babies died - 84 in Take care &Insure – 87 Percen of BPD = 9/100 = 0.09 ; 9/84 = 10.7% of BPD ( InSurE = 17/100 = 0.17 ; 17/87 = 19.5Relative risk – 0.09 / 0.17 = 0.52 Insufficient power to detect CLD
Technique Hobart TechniqueDargaville PA, Aiyappan A, Cornelius A,Williams C, De Paoli AG. Preliminaryevaluationof a new technique of minimally invasivesurfactant therapy. Arch Dis Child Fetal Neonatal Ed. 2011;96(4):F243–F248 ?Generalisation of the technique
Alternative ways of surfactant administration without PPV – MISTAdministration of surfactant via a thin catheter duringspontaneous breathing with CPAP - used since 2001.Catheter placed with Magill forceps into the tracheaunder direct laryngoscopy and surfactant is appliedover a period of 1 to 3 minutes.
Peridosing eventsDargaville et al ( Hobart Technique ) - use of a morestable vascular catheter for the procedure, whichallowed placement without use of the Magill forceps.Fewer peridosing events with take care ,such as failureof the first attempt of catheterization, bradycardia,surfactantreflux, and PPV requirement, by usingthistechnique in comparison with Dargaville et al’s report. ? Study conducted by single experienced Neonatologist – Difficulty in Generalisation of the result
Reintubation - fio2 60% ( not generally practised )Single centre study
Limitations ( Authors )Limitations – Authors• Only one agent used - poractant alpha• Single centre study• Insufficient power to detect BPD
Applicability in practice The population studied appears to be very different – appears to be more sick , Rapid rise in FiO2 req , Low PH and clinical status Technique - ? Feasible by experienced physicians Single centre study Needs more research for wider applicability