Use of Bubble Continuous Positive Airway Pressure Compared to Nasal Prong Oxygen or Humidified High Flow in Children Under Five With Severe Pneumonia and Hypoxaemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2011 by International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor:
Collaborators:
AusAID
University of Melbourne
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT01396759
First received: July 6, 2011
Last updated: July 9, 2014
Last verified: March 2011
  Purpose

Continuous Positive Airway Pressure (CPAP) is a common form of support for patients admitted to Intensive Care Units (ICUs) of industrialized countries with respiratory distress (1). Nasal CPAP (NCPAP) is effective in correcting hypoxemia and contributes to reducing the number of children requiring endo-tracheal intubation and mechanical ventilation (2). CPAP is most frequently delivered to neonates using conventional mechanical ventilators, and thus there is minimal or no cost saving. There are other ways of delivering CPAP, such as Bubble-CPAP, which requires a source of gas flow (typically 6-8 L/ minute in a neonate), an air-oxygen blender, a humidifier and a T-piece.(3). The expiratory arm is inserted in a bottle of water and the level of CPAP delivered is equivalent to the length of the expiratory tubing that remains under water. Robust equipment is now available at a fraction of the cost of mechanical ventilators. Bubble-CPAP has potential advantages over the mechanical ventilation, such as lower cost, ease of application by nursing staff, lower risk of complications, and has been proposed as an inexpensive method of delivering CPAP in developing countries (3).

High flow air/oxygen mix is useful in reducing the indication of mechanical ventilation (4); however, there is a lack of randomized studies comparing it with bubble CPAP or with standard flow O2 supplementation by nasal prongs. High flow air/oxygen mix uses flows of 2 litre per kg per minute of blended air/oxygen mix, usually with a low fraction of inspired oxygen (say 25-40%). It is easy to apply, but requires additional equipment to standard oxygen therapy, and closer monitoring. "High flow" delivers uncertain levels of CPAP, so it is not clearly superior to bubble-CPAP, and there have been no controlled comparative trials of these two techniques.

Pneumonia and malnutrition are two of the most common co-morbidities in children in developing countries (5). In hospitals in resource-poor settings, children with severe malnutrition and pneumonia often present with respiratory distress with or without severe hypoxaemia and impending respiratory failure (6). They initially receive O2 supplementation through nasal prong or face mask. Support from bubble CPAP might help to effectively treat hypoxaemia, improve respiratory function, avoid the need for mechanical ventilation and its complications, and reduce mortality.

Almost half of the patients admitted in the intensive care unit of the Dhaka hospital of ICDDR,B present with hypoxaemia, many with impending respiratory failure. Children with pneumonia also invariably have severe malnutrition with or without diarrhoea (Chisti MJ, MMed thesis, unpublished data). They often need mechanical ventilation, with attendant costs, complications and high mortality rates. However, no published data are available about the use of bubble-CPAP in children with pneumonia and malnutrition and there have been no controlled trials of CPAP in developing countries.

The Hypothesis is:

In children with severe pneumonia and hypoxaemia the probability of treatment failure (see definition below) will be significantly lower when respiratory support is initially provided by bubble-CPAP or high-flow, humidified air/O2 mix by nasal prongs, compared to standard oxygen flow.


Condition Intervention
Pneumonia
Hypoxaemia
Procedure: Bubble continuous positive airway pressure
Procedure: Humidified high flow air / O2 mix at 2 l/kg/min
Procedure: Standard O2 supplementation by nasal cannula at 0.5 - 2 l/min

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Use of Bubble CPAP Compared to Nasal Prong Oxygen or Humidified High Flow in Children Under Five With Severe Pneumonia and Hypoxaemia: a Randomized Trial

Resource links provided by NLM:


Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • Treatment failure [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Severe hypoxaemia (SpO2<85%) after being on one of the study arm treatments for >1 hour Clinical signs of exhaustion, including active contraction of respiratory muscles with paradoxical abdominal and thoracic motion, gasping, severe chest wall in-drawing PCO2 >80mm Hg and pH<7.2 on capillary blood gas OR


Secondary Outcome Measures:
  • Mortality rate [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    1. Mortality rate calculated at hospital discharge
    2. Rate of need for mechanical ventilation
    3. Rates of nosocomial infections
    4. Rates of multi-organ failure at 7 days
    5. Length of hospital stay
    6. Rate of absconding
    7. Bacterial aetiology
    8. Rates of isolation of TB


Estimated Enrollment: 975
Study Start Date: July 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bubble CPAP
Children will receive bubble CPAP Bubble-CPAP, which requires a source of gas flow (typically 6-8 L/ minute in a neonate), an air-oxygen blender, a humidifier and a T-piece. The expiratory arm is inserted in a bottle of water and the level of CPAP delivered is equivalent to the length of the expiratory tubing that remains under water. Robust equipment is now available at a fraction of the cost of mechanical ventilators. Bubble-CPAP has potential advantages over the mechanical ventilation, such as lower cost, ease of application by nursing staff, lower risk of complications, and has been proposed as an inexpensive method of delivering CPAP in developing countries.
Procedure: Bubble continuous positive airway pressure
All children will be monitored for by pulse oximetry for arterial O2 saturation, respiratory rate, lower chest wall in-drawing, intercostal retraction, head nodding, cyanosis, tracheal tug, heart failure (defined by the presence of tachypnea, tachycardia, gallop rhythm, hepatomegaly, pedal oedema, basal crackles). Arterial or capillary blood gas analyses will be done for children failing to maintain saturation (>90% with allocated treatment), or if there is concern about hypercarbia or acidosis.
Experimental: High flow air/ oxygen mix
High flow air/ oxygen mix is useful in reducing the indication of mechanical ventilation (4); however, there is a lack of randomized studies comparing it with bubble CPAP or with standard flow O2 supplementation by nasal prongs. High flow air/oxygen mix uses flows of 2 litre per kg per minute of blended air / oxygen mix, usually with a low fraction of inspired oxygen (say 25-40%).
Procedure: Humidified high flow air / O2 mix at 2 l/kg/min
Humidified high flow air / O2 mix at 2 l/kg/min through nasal canula. All children will be monitored for by pulse oximetry for arterial O2 saturation, respiratory rate, lower chest wall in-drawing, intercostal retraction, head nodding, cyanosis, tracheal tug, heart failure (defined by the presence of tachypnea, tachycardia, gallop rhythm, hepatomegaly, pedal oedema, basal crackles). Arterial or capillary blood gas analyses will be done for children failing to maintain saturation (>90% with allocated treatment), or if there is concern about hypercarbia or acidosis.
Active Comparator: Standard O2 supplementation by nasal prongs
Standard O2 supplementation by nasal prongs @ 0.5-2.0 litre per minute
Procedure: Standard O2 supplementation by nasal cannula at 0.5 - 2 l/min
Standard O2 supplementation will be given by nasal cannula at 0.5 - 2 l/min. All children will be monitored for by pulse oximetry for arterial O2 saturation, respiratory rate, lower chest wall in-drawing, intercostal retraction, head nodding, cyanosis, tracheal tug, heart failure (defined by the presence of tachypnea, tachycardia, gallop rhythm, hepatomegaly, pedal oedema, basal crackles). Arterial or capillary blood gas analyses will be done for children failing to maintain saturation (>90% with allocated treatment), or if there is concern about hypercarbia or acidosis.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Children of either sex, aged 0-4 years, with severe/very severe pneumonia (per WHO guidelines) and hypoxaemia (SpO2 < 90%) will be included in our study in the ARI Unit of the Longer Stay Ward (LSW), High Dependency Unit HDU, and ICU unit of Dhaka Hospital of ICDDR,B.

Exclusion Criteria:

Children with uncorrected cyanotic CHD, hypercapnoea (PCO2 > 65 mm of Hg), status asthmaticus and upper-airway obstruction, and those for whom inform consent can't be secured from their parents/ care-givers. Children with features (any two of three criteria given below) of "treatment failure" on admission (before enrollment into the study) will also be excluded from the study. Arterial blood gas analysis will be performed to check the exclusion criteria

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01396759

Contacts
Contact: Mohammod J Chisti, MBBS, MMed 880-2-8860523-32 ext 2334 chisti@icddrb.org

Locations
Bangladesh
Dhaka Hospital, ICDDR,B Recruiting
Dhaka, Bangladesh, 1212
Contact: Mohammod J Chisti, MBBS, MMed    880-2-8860523-32 ext 2334    chisti@icddrb.org   
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
AusAID
University of Melbourne
  More Information

No publications provided

Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT01396759     History of Changes
Other Study ID Numbers: PR-10088
Study First Received: July 6, 2011
Last Updated: July 9, 2014
Health Authority: Bangladesh: Ethical Review Committee

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Bubble CPAP
Humidified high flow
Hypoxaemia
Nasal prong
Severe pneumonia

Additional relevant MeSH terms:
Pneumonia
Anoxia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014