None listed
Conditions
Brief summary
Primary purpose of the study The hypothesis of this study is that heated humidified high flow nasal cannula (HHHFNC) oxygen therapy for children in the post anaesthetic care unit (PACU) can reduce the incidence of hypoxia, compared to children treated with Hudson face mask oxygen therapy. The primary purpose of this study is to discover whether oxygen treatment using HHHFNC therapy can reduce the incidence of hypoxia found in children treated in the paediatric post anaesthethetic care unit (PACU) compared to children treated with oxygen through a Hudson mask, during their stay in PACU. This study is designed to discover the incidence of hypoxia (defined as oxygen saturation levels which are equal to or less than 90 percent and severe hypoxia where oxygen saturation levels are equal to or less than 85 percent) in children treated with oxygen through a Hudson mask during their stay in the PACU. This is the current treatment in the PACU. Having found the baseline incidence of hypoxia, a second group of children will be treated in the PACU using HHHFNC oxygen treatment and oxygen saturation levels will also be measured. Both groups will then be analysed and compared, looking for the respective incidence of hypoxia. All children will be observed throughout their stay in the PACU. Oxygen saturation levels will be recorded from the PACU monitors, and research assistants will observe oxygen levels and record any treatment by recovery nurses who are using techniques to avoid hypoxic episodes (these include positioning, use of airway devices such as oropharyngeal airways, use of medication to reverse respiratory depression, calling for help, increasing oxygen levels or instrumenting the airway). Hudson masks are the current masks used in most PACUs throughout New Zealand. They deliver approximately 30 percent oxygen when 6 litre per minute of oxygen is used. Heated humidified high flow nasal cannula treatment has been used to treat all ages of children in the intensive care unit for the past 16 years. The children will receive 2 litre per kilogram per minute of oxygen (up to a maximum flow of 50 litres per minute) at a concentration of 30 percent oxygen. This form of treatment can provide positive pressure, is comfortable to breathe through and may increase the clearance of anaesthetic gases which may reduce the recovery time.
Interventions
This interventional study will record the oxygen saturation levels and interventions required to avoid hypoxia for the duration of the patients stay in a paediatric postoperative anaesthetic care unit (PACU). Each participant receives treatment with either Hudson mask or HHHFNC for the duration of their PACU stay, based on the time of admission to the PACU until the time they leave the PACU. The Hudson mask phase of the study took place from September to December 2015, then HHHFNC intervention p
This interventional study will record the oxygen saturation levels and interventions required to avoid hypoxia for the duration of the patients stay in a paediatric postoperative anaesthetic care unit (PACU). Each participant receives treatment with either Hudson mask or HHHFNC for the duration of their PACU stay, based on the time of admission to the PACU until the time they leave the PACU. The Hudson mask phase of the study took place from September to December 2015, then HHHFNC intervention phase from September to December 2016. During the stay in PACU, the patients will be receiving oxygen treatment by a variety of methods including Hudson mask and heated humidified high flow nasal cannula. The study is designed to compare Hudson mask treatment to heated humidified high flow nasal cannula treatment. A Hudson mask covers the patient's face and delivers gas for mouth or nose breathing. HHHFNC delivers gas through the patients nose via cannulae. A variety of other treatments do occur (including oxygen via a supraglottic airway, tracheal tube, tracheostomy tube of patient spontaneously breathing air) but they will be excluded from the study. The majority of our PACU patients (70%) normally receive oxygen via a Hudson mask. The study is designed to compare our standard majority treatment (Hudson mask) to HHHFNC. Alternative treatments are occasionally chosen by anaesthetists, but these different treatments are not standardised and therefore cannot be a valid comparison. However, regardless of treatment technique, all the baseline measurements (oxygen saturations and clinical intervention) will be recorded for these alternative therapies. The observation period will from the time the patient enters the PACU, until they leave the PACU. The HHHFNC period will be for the purpose of the study, to allow a comparision of patients with Hudson mask treatment and HHHFNC treatment. The introduction of HHHFNC is for the purposes of the study. Each patient receives oxygen treatment via Hudson mask or HHHFNC until the attending recovery room nurse deems it is no longer necessary, and then removes it. The duration of each patients oxygen treatment is recorded by the research assistant. Patients will resort to our standard Hudson mask treatment after the study. Children receiving Hudson mask treatment receive oxygen at 6L/min which delivers 30% oxygen as dry unhumidified gas (this is standard treatment in our PACU). Children receiving HHHFNC treatment receive gas flow at 2L/Kg/min (up to a maximum of 50L/min) and an inspired oxygen concentration of 30% (this oxygen concentration is equivalent to oxygen concentration received through a Hudson mask at 6L/min. The gas is heated to 37 degrees saturated (body temperature and 100% relative humidity or 44 mg/litre of water vapour).
Sponsors
University of Auckland
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
No minimum to 16 Years
Healthy volunteers
No
Inclusion criteria
Males and females, age 16 years and under admitted to PACU following anaesthesia or sedation
Exclusion criteria
1. Current participant on any other clinical study 2. Serious abdominal, cardiac or respiratory malformations including tracheo-oesophageal fistul (TOF), intestinal atresia, omphalocele, gastroschisis, or diaphragmatic hernia. 3. Patients with chronic hypoxia (cardiac, renal, haematological or respiratory etiology) 4. Admitted to PACU with a supraglottic airway (SGA) in situ 5. Admitted to PACU with a tracheal tube in situ 6. Admitted to PACU with a tracheostomy tube in situ
Outcome results
None listed