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Journal club
Dr. C.Kannan,
1st year PG
Pediatrics department
MGMCRI
Heated Humidified High Flow Nasal Cannula
versus
Nasal Continuous Positive Airway Pressure
as Primary Mode of Respiratory Support for
Respiratory Distress in Preterm Infants
FROM INDIAN PEDIATRICS
 Received: March 10, 2015;
 Initial review: April 30, 2015;
 Accepted: November 28, 2015.
Indian Pediatrics
 The official publication of the Indian Academy of Paediatrics
(IAP),
 Indexed by leading international services including Index
Medicus.
 The journal began publication in 1963.
 Indian Paediatrics has a permanent Editorial Office situated at
New Delhi, India.
 It is published monthly and has a current circulation of about
23,000.
 The journal gives priority to reports of outstanding clinical and
experimental work as well as important contributions related to
common and topical problems in India and the developing
countries
AUTHORS
DEEPARAJ HEGDE, JAYASHREE MONDKAR, HARSHAD PANCHAL, SWATI
MANERKAR, BONNY JASANI AND NANDKISHOR KABRA
 From Department of Neonatology,
 Lokmanya Tilak Municipal and General Hospital, and
 Seth GS Seth Medical college and KEM Hospital; Mumbai, India.
Correspondence to:
 Dr Deeparaj Hegde,
 Department of Neonatology,
 LTMMC and LTMG hospital, Sion (West), Mumbai, India.
OBJECTIVE
 To compare the efficacy of HHHFNC vs Nasal
CPAP in Preterm infants with mild to moderate
respiratory distress as a primary mode of
respiratory support.
Heat Humidified High Flow Nasal
Cannula
 High flow nasal cannula is a device
used to deliver fixed supplemental oxygen
or air flow to a patient in need of
respiratory help
 HHHFNC
oxygen therapy is
accompanied by heated humidification
systems to prevent the associated dying
of upper airway mucosa and to increase
the patient comfort
HHHFNC
Nasal bubble CPAP
 A non-invasive ventilation method
 CPAP is delivered to a spontaneously
breathing newborn
 To maintain lung volumes during expiration.
 Blended and humidified oxygen is delivered via
short binasal prongs or a nasal mask
 pressure in the circuit is maintained by
immersing the distal end of the expiratory tubing in
water.
 The depth to which the tubing is immersed
underwater determines the pressure generated in
the airways of the infant.
 As the gas flows through the system, it
“bubbles” out and prevents build-up of excess
Nasal bubble CPAP
OUTCOMES
Primary outcome
 Look at failure of non invasive ventilation at 72 hours
 MV within 72 hr of starting either HHHFNC or NCPAP support
Secondary outcomes
 The duration of non invasive ventilation(NIV)
 Duration of oxygen
 Frequency of air leaks
 BPD(oxygen treatment for >4 weeks)
OTHER OUTCOMES
 Frequency of patent ductus arteriosus (PDA),
 Necrotizing enterocolitis (NEC),
 Intraventricular hemorrhage (IVH) grades 3 and 4,
 Retinopathy of prematurity (ROP) ≥ stage 3,
 Time to full feeds, Feeding intolerance
 Gastrointestinal perforation
 Clinical and culture proven Early onset sepsis (EOS) and
 Late onset sepsis (LOS),
 length of hospital stay, Mortality and Nasal trauma.
NASAL TRAUMA
Classified as
Mild
 With erythema and tenderness
 Treated with Repositioning of the interface and external massage
Moderate
 With indentation over nasal septum or excoriation
 Mupirocin ointment and occlusive plastic dressing
Severe
 Columella necrosis or bleeding
 Mupirocin ointment and occlusive plastic dressing
METHODOLOGY - STUDY DETAILS
Study Design:
 Prospective observational cohort study
Setting :
 Tertiary care level III neonatal intensive care unit
Participants - sample size ???
 88 preterm infants
Selection criteria
Inclusions
 28 to 34 weeks of gestation
 with mild to moderate
respiratory distress
 within 6 hours of birth.
Exclusions
 Infants with 5 minute Apgar
scores <5
 Nasopharyngeal pathology
Choanal atresia,
Cleft lip or palate
 Major congenital
malformations
 Those with antenatally
diagnosed congenital heart
disease
Mild to moderate respiratory distress
 Silverman-Anderson score (SAS) of 3-6,
 FiO2 requirement ≤60% to maintain SpO2 between 88-
93%,
 Arterial pH >7.2 and
 PaCO2 <60 mmHg.
Silverman Anderson Score
Features Score 0 Score 1 Score 2
 Upper chest movement Synchronous Inspiratory lag See – saw respiration
 Lower chest movement None Minimal Marked
 Xiphoid retractions None Minimal Marked
 Nasal flaring None Minimal Marked
 Grunting None Audible with steth Audible without steth
Score >4 indicates clinical respiratory distress
Score >7 indicates impending respiratory failure
METHODOLOGY - STUDY DETAILS
Intervention done
 Eligible infants were treated either with
Heated Humidified High Flow Nasal Cannula (n=46) or
Nasal Continuous Positive Airway Pressure (n=42).
How was subjects grouped
 Institute had two HHHFNC and two Bubble NCPAP systems in their
unit.
 Eligible infants were allocated to either of the device(HHHFNC or
NCPAP) depending on the availability of the device.
 If both the devices were available at the time of allocation, the infant
was allocated to NCPAP.
Administration of HHHFNC
Apparatus
 Using RT329 Infant oxygen therapy Breathing Circuit and
 MR850 Humidifier using short binasal prongs.
 The size of the nasal prongs
 Should not exceed more than 50% of the size of the nares.
Initiation
 At a flow of 3 L/min with
 FiO2 titrated to a maximum of 60%
 To maintain SpO2 between 88-93%.
 Changes in flow was made by increments of 1L/min to a
 Maximum flow of 6 L/min if distress persisted.
Weaning
 Stepwise reduction of FiO2 to 21% and
 Flow to 1 L/min,
 Followed by removal of HHHFNC at 1 L/min and 21% oxygen.
NCPAP Administration(By Bubble CPAP)
Apparatus
 Using MR850 humidifier with
 Short binasal prongs
NCPAP was initiated
 At PEEP of 5 cm H2O,
 Flow of 6L/min
 To maintain SpO2 between 88-93 %.
Maximum Limits
 CPAP of 7 cmH2O and
 FiO2 of 60%,
 Flow of 8L/min for adequate bubbling in the water chamber.
The criteria for weaning in both
Absence of respiratory distress
 With minimal or no retractions (SAS score: 0-1)
 Respiratory rate between 40 and 60 per minute
 SpO2 > 90%
 On FiO2 <30% and
 PEEP <5 cm H2O.
Weaning from CPAP used stepwise reduction of
 FiO2 by 60% to 21% and
 CPAP to 4cm H2O
 Followed by removal of CPAP prongs.
Failure of HHHFNC or NCPAP
 Remained hypoxic, i.e.
SpO2 <88% despite FiO2 > 60%,
Flow rate
Flow >6L/min for HHHFNC group and
PEEP >7 cm H2O for NCPAP group
 SAS score >6 despite the maximum settings
 Had recurrent apnea (>3 episodes within 24 hours) or
 Any episode of apnea requiring bag and mask ventilation
 Had pH<7.2, or PaCO2 >60 mmHg
 Required inotropic support.
Infants considered to have HHHFNC/NCPAP failure were
managed by intubation and MV.
STATISTICAL METHODS
 With a two sided α error of 0.05 and power 80%
 The estimated sample size was 90 (45 in each group)
 To compare the baseline and outcome variables on a continuous
scale
Two sample t tests or
Mann Whitney U test were used as appropriate
 To compare the baseline and outcome variables on nominal type of
data
Chi Square test or
Fisher Exact test were used as appropriate
 A two sided p value <0.05 was considered significant
 Statistical analysis was performed using SPSS
Statistics
COMPARISON OF BASELINE CHARACTERISTICS IN THE
TWO GROUPS
Baseline Characteristics HHHFNC (n=46) NCPAP (n=42) P value
 Gestational age (wk) 31.1 (2.3) 31.4 ( 2.3) 0.22
 Birthweight (g) 1313 (211) 1353 (208) 0.07
 Male gender 25 (54%) 18 (43%) 0.30
 IUGR 7 (15%) 8 (19%) 0.77
Steroids
 No steroids 19 (41%) 19 (45%)
 Inadequate steroids 14 (30%) 10 (24%) 0.78
 Adequate steroids 13 (28%) 13 (31%)
 Vaginal delivery 28 (61%) 33 (78%) 0.07
 Resuscitated at birth 15 (33%) 14 (33%) 0.94
 APGAR Score at 5 minute 8 (7,8) 8 (7,8) 0.35
 Silverman Anderson Score 4 (4,5) 5 (4,5) 0.08
 FiO2 at initiation 41.2 (8.7) 39.7 (9.4) 0.11
 Surfactant 25 (54%) 30 (71%) 0.12
 Age at receiving surfactant (h) 2.46 (2.5) 2.83 (2.26) 0.46
 Age at starting respiratory support (h) 2.33 (1.09) 1.82 (1.25) 0.05
PRIMARY AND SECONDARY OUTCOMES IN TWO
STUDY GROUPS
Outcomes HHHFNC NCPAP Relative risk/Mean P
value
(n=46)(%) (n=42)(%) difference ( 95 % CI)
 Failure 9 (19.5%) 11 (26.2%) 0.74 (0.34-1.62)
0.46
 Duration support 67.15(40.69) 66.9 (36.1) 0.25 ( -15.79 to 16.29)
0.98
 Ventilator days 2.0 (0.81) 1.75 (0.86) 0.25 ( -0.10 to 0.60)
0.16
 O2 Days 3.76 (2.6) 3.5 (2.2) 0.26 ( -0.74 to 1.26)
0.62
 BPD 2 (4.3%) 1 (2.3%) 1.82 (0.17-19.4)
0.61
 PDA 12 (26%) 10 (24%) 1.09 (0.52- 2.60)
0.80
 Feed intolerance 10 (22%) 9 (21%) 1.01 (0.45-2.25)
0.71
 NEC 3 (6.5%) 2 (4.7%) 1.36 (0.24-7.80)
0.72
Results
 The failure rate for primary outcome (MV rate in 72 hours)
26.2% in CPAP group.
19.5% in HHHFNC group
 No significant difference in the secondary outcomes as mentioned
earlier
 None of the infants in either group developed
Pneumothorax or
Gastrointestinal perforation
 Moderate or severe nasal trauma occurred significantly less
frequently
HHHFNC (10.9%)
NCPAP (40.5%)
Limitations of this study
 Randomization was not properly done as the observer is
aware of allotment systems(HHHFNC & Nasal CPAP) to
preterms
 Sample size is less
 X ray diagnosis was not mentioned elsewhere in the study to
rule out other pathologies of lung
Conclusion
 HHHFNC appears to have similar efficacy
and safety to NCPAP
 HHHFNC causes less nasal trauma than
NCPAP
 The use of HHHFNC as a primary therapy for
respiratory distress from birth requires further
research in form of well-designed randomized
controlled trials with Adequate sample size
Message
 HHHFNC is patient friendly
 HHHFNC has Similar efficacy and less nasal trauma
 Can we change the routine romo drain CPAP to HHHFNC in
our institute - Cost benefit of the HHHFNC ???
THANK YOU !!

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HHHNFC Vs BUBBLE CPAP

  • 1. Journal club Dr. C.Kannan, 1st year PG Pediatrics department MGMCRI
  • 2. Heated Humidified High Flow Nasal Cannula versus Nasal Continuous Positive Airway Pressure as Primary Mode of Respiratory Support for Respiratory Distress in Preterm Infants FROM INDIAN PEDIATRICS  Received: March 10, 2015;  Initial review: April 30, 2015;  Accepted: November 28, 2015.
  • 3. Indian Pediatrics  The official publication of the Indian Academy of Paediatrics (IAP),  Indexed by leading international services including Index Medicus.  The journal began publication in 1963.  Indian Paediatrics has a permanent Editorial Office situated at New Delhi, India.  It is published monthly and has a current circulation of about 23,000.  The journal gives priority to reports of outstanding clinical and experimental work as well as important contributions related to common and topical problems in India and the developing countries
  • 4. AUTHORS DEEPARAJ HEGDE, JAYASHREE MONDKAR, HARSHAD PANCHAL, SWATI MANERKAR, BONNY JASANI AND NANDKISHOR KABRA  From Department of Neonatology,  Lokmanya Tilak Municipal and General Hospital, and  Seth GS Seth Medical college and KEM Hospital; Mumbai, India. Correspondence to:  Dr Deeparaj Hegde,  Department of Neonatology,  LTMMC and LTMG hospital, Sion (West), Mumbai, India.
  • 5. OBJECTIVE  To compare the efficacy of HHHFNC vs Nasal CPAP in Preterm infants with mild to moderate respiratory distress as a primary mode of respiratory support.
  • 6. Heat Humidified High Flow Nasal Cannula  High flow nasal cannula is a device used to deliver fixed supplemental oxygen or air flow to a patient in need of respiratory help  HHHFNC oxygen therapy is accompanied by heated humidification systems to prevent the associated dying of upper airway mucosa and to increase the patient comfort
  • 8. Nasal bubble CPAP  A non-invasive ventilation method  CPAP is delivered to a spontaneously breathing newborn  To maintain lung volumes during expiration.  Blended and humidified oxygen is delivered via short binasal prongs or a nasal mask  pressure in the circuit is maintained by immersing the distal end of the expiratory tubing in water.  The depth to which the tubing is immersed underwater determines the pressure generated in the airways of the infant.  As the gas flows through the system, it “bubbles” out and prevents build-up of excess
  • 10. OUTCOMES Primary outcome  Look at failure of non invasive ventilation at 72 hours  MV within 72 hr of starting either HHHFNC or NCPAP support Secondary outcomes  The duration of non invasive ventilation(NIV)  Duration of oxygen  Frequency of air leaks  BPD(oxygen treatment for >4 weeks)
  • 11. OTHER OUTCOMES  Frequency of patent ductus arteriosus (PDA),  Necrotizing enterocolitis (NEC),  Intraventricular hemorrhage (IVH) grades 3 and 4,  Retinopathy of prematurity (ROP) ≥ stage 3,  Time to full feeds, Feeding intolerance  Gastrointestinal perforation  Clinical and culture proven Early onset sepsis (EOS) and  Late onset sepsis (LOS),  length of hospital stay, Mortality and Nasal trauma.
  • 12. NASAL TRAUMA Classified as Mild  With erythema and tenderness  Treated with Repositioning of the interface and external massage Moderate  With indentation over nasal septum or excoriation  Mupirocin ointment and occlusive plastic dressing Severe  Columella necrosis or bleeding  Mupirocin ointment and occlusive plastic dressing
  • 13. METHODOLOGY - STUDY DETAILS Study Design:  Prospective observational cohort study Setting :  Tertiary care level III neonatal intensive care unit Participants - sample size ???  88 preterm infants
  • 14. Selection criteria Inclusions  28 to 34 weeks of gestation  with mild to moderate respiratory distress  within 6 hours of birth. Exclusions  Infants with 5 minute Apgar scores <5  Nasopharyngeal pathology Choanal atresia, Cleft lip or palate  Major congenital malformations  Those with antenatally diagnosed congenital heart disease
  • 15. Mild to moderate respiratory distress  Silverman-Anderson score (SAS) of 3-6,  FiO2 requirement ≤60% to maintain SpO2 between 88- 93%,  Arterial pH >7.2 and  PaCO2 <60 mmHg.
  • 16. Silverman Anderson Score Features Score 0 Score 1 Score 2  Upper chest movement Synchronous Inspiratory lag See – saw respiration  Lower chest movement None Minimal Marked  Xiphoid retractions None Minimal Marked  Nasal flaring None Minimal Marked  Grunting None Audible with steth Audible without steth Score >4 indicates clinical respiratory distress Score >7 indicates impending respiratory failure
  • 17. METHODOLOGY - STUDY DETAILS Intervention done  Eligible infants were treated either with Heated Humidified High Flow Nasal Cannula (n=46) or Nasal Continuous Positive Airway Pressure (n=42).
  • 18. How was subjects grouped  Institute had two HHHFNC and two Bubble NCPAP systems in their unit.  Eligible infants were allocated to either of the device(HHHFNC or NCPAP) depending on the availability of the device.  If both the devices were available at the time of allocation, the infant was allocated to NCPAP.
  • 19. Administration of HHHFNC Apparatus  Using RT329 Infant oxygen therapy Breathing Circuit and  MR850 Humidifier using short binasal prongs.  The size of the nasal prongs  Should not exceed more than 50% of the size of the nares. Initiation  At a flow of 3 L/min with  FiO2 titrated to a maximum of 60%  To maintain SpO2 between 88-93%.  Changes in flow was made by increments of 1L/min to a  Maximum flow of 6 L/min if distress persisted. Weaning  Stepwise reduction of FiO2 to 21% and  Flow to 1 L/min,  Followed by removal of HHHFNC at 1 L/min and 21% oxygen.
  • 20. NCPAP Administration(By Bubble CPAP) Apparatus  Using MR850 humidifier with  Short binasal prongs NCPAP was initiated  At PEEP of 5 cm H2O,  Flow of 6L/min  To maintain SpO2 between 88-93 %. Maximum Limits  CPAP of 7 cmH2O and  FiO2 of 60%,  Flow of 8L/min for adequate bubbling in the water chamber.
  • 21. The criteria for weaning in both Absence of respiratory distress  With minimal or no retractions (SAS score: 0-1)  Respiratory rate between 40 and 60 per minute  SpO2 > 90%  On FiO2 <30% and  PEEP <5 cm H2O. Weaning from CPAP used stepwise reduction of  FiO2 by 60% to 21% and  CPAP to 4cm H2O  Followed by removal of CPAP prongs.
  • 22. Failure of HHHFNC or NCPAP  Remained hypoxic, i.e. SpO2 <88% despite FiO2 > 60%, Flow rate Flow >6L/min for HHHFNC group and PEEP >7 cm H2O for NCPAP group  SAS score >6 despite the maximum settings  Had recurrent apnea (>3 episodes within 24 hours) or  Any episode of apnea requiring bag and mask ventilation  Had pH<7.2, or PaCO2 >60 mmHg  Required inotropic support. Infants considered to have HHHFNC/NCPAP failure were managed by intubation and MV.
  • 23. STATISTICAL METHODS  With a two sided α error of 0.05 and power 80%  The estimated sample size was 90 (45 in each group)  To compare the baseline and outcome variables on a continuous scale Two sample t tests or Mann Whitney U test were used as appropriate  To compare the baseline and outcome variables on nominal type of data Chi Square test or Fisher Exact test were used as appropriate  A two sided p value <0.05 was considered significant  Statistical analysis was performed using SPSS
  • 25. COMPARISON OF BASELINE CHARACTERISTICS IN THE TWO GROUPS Baseline Characteristics HHHFNC (n=46) NCPAP (n=42) P value  Gestational age (wk) 31.1 (2.3) 31.4 ( 2.3) 0.22  Birthweight (g) 1313 (211) 1353 (208) 0.07  Male gender 25 (54%) 18 (43%) 0.30  IUGR 7 (15%) 8 (19%) 0.77 Steroids  No steroids 19 (41%) 19 (45%)  Inadequate steroids 14 (30%) 10 (24%) 0.78  Adequate steroids 13 (28%) 13 (31%)  Vaginal delivery 28 (61%) 33 (78%) 0.07  Resuscitated at birth 15 (33%) 14 (33%) 0.94  APGAR Score at 5 minute 8 (7,8) 8 (7,8) 0.35  Silverman Anderson Score 4 (4,5) 5 (4,5) 0.08  FiO2 at initiation 41.2 (8.7) 39.7 (9.4) 0.11  Surfactant 25 (54%) 30 (71%) 0.12  Age at receiving surfactant (h) 2.46 (2.5) 2.83 (2.26) 0.46  Age at starting respiratory support (h) 2.33 (1.09) 1.82 (1.25) 0.05
  • 26. PRIMARY AND SECONDARY OUTCOMES IN TWO STUDY GROUPS Outcomes HHHFNC NCPAP Relative risk/Mean P value (n=46)(%) (n=42)(%) difference ( 95 % CI)  Failure 9 (19.5%) 11 (26.2%) 0.74 (0.34-1.62) 0.46  Duration support 67.15(40.69) 66.9 (36.1) 0.25 ( -15.79 to 16.29) 0.98  Ventilator days 2.0 (0.81) 1.75 (0.86) 0.25 ( -0.10 to 0.60) 0.16  O2 Days 3.76 (2.6) 3.5 (2.2) 0.26 ( -0.74 to 1.26) 0.62  BPD 2 (4.3%) 1 (2.3%) 1.82 (0.17-19.4) 0.61  PDA 12 (26%) 10 (24%) 1.09 (0.52- 2.60) 0.80  Feed intolerance 10 (22%) 9 (21%) 1.01 (0.45-2.25) 0.71  NEC 3 (6.5%) 2 (4.7%) 1.36 (0.24-7.80) 0.72
  • 27. Results  The failure rate for primary outcome (MV rate in 72 hours) 26.2% in CPAP group. 19.5% in HHHFNC group  No significant difference in the secondary outcomes as mentioned earlier  None of the infants in either group developed Pneumothorax or Gastrointestinal perforation  Moderate or severe nasal trauma occurred significantly less frequently HHHFNC (10.9%) NCPAP (40.5%)
  • 28. Limitations of this study  Randomization was not properly done as the observer is aware of allotment systems(HHHFNC & Nasal CPAP) to preterms  Sample size is less  X ray diagnosis was not mentioned elsewhere in the study to rule out other pathologies of lung
  • 29. Conclusion  HHHFNC appears to have similar efficacy and safety to NCPAP  HHHFNC causes less nasal trauma than NCPAP  The use of HHHFNC as a primary therapy for respiratory distress from birth requires further research in form of well-designed randomized controlled trials with Adequate sample size
  • 30. Message  HHHFNC is patient friendly  HHHFNC has Similar efficacy and less nasal trauma  Can we change the routine romo drain CPAP to HHHFNC in our institute - Cost benefit of the HHHFNC ???