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

NCT01396759 | Completed DMC

• 1 other identifier: PR-10088
• Study Type: interventional
• Target: 975
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pneumonia; Hypoxaemia

Keywords

Bubble CPAP; Humidified high flow; Hypoxaemia; Nasal prong; Severe pneumonia

Outcome Measures

Primary Outcomes (1)

• Treatment failure

  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

  24 months

Secondary Outcomes (1)

• Mortality rate

  24 months

Study Arms (3)

bubble CPAP

EXPERIMENTAL

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

High flow air/ oxygen mix

EXPERIMENTAL

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

Standard O2 supplementation by nasal prongs

ACTIVE COMPARATOR

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

Interventions

Bubble continuous positive airway pressure PROCEDURE

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.

bubble CPAP

Humidified high flow air / O2 mix at 2 l/kg/min PROCEDURE

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.

High flow air/ oxygen mix

Standard O2 supplementation by nasal cannula at 0.5 - 2 l/min PROCEDURE

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.

Standard O2 supplementation by nasal prongs

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• AusAID: collaborator
• University of Melbourne: collaborator

Study Sites (1)

Dhaka Hospital, ICDDR,B

Dhaka, 1212, Bangladesh

Location

Related Publications (1)

• Chisti MJ, Salam MA, Smith JH, Ahmed T, Pietroni MA, Shahunja KM, Shahid AS, Faruque AS, Ashraf H, Bardhan PK, Sharifuzzaman, Graham SM, Duke T. Bubble continuous positive airway pressure for children with severe pneumonia and hypoxaemia in Bangladesh: an open, randomised controlled trial. Lancet. 2015 Sep 12;386(9998):1057-65. doi: 10.1016/S0140-6736(15)60249-5. Epub 2015 Aug 19.

  PMID: 26296950 DERIVED

MeSH Terms

Conditions

Pneumonia; Hypoxia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2011
• First Posted: July 19, 2011
• Study Start: July 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 28, 2015

Record last verified: 2015-06

Locations

BA (1)