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Trial registered on ANZCTR


Registration number
ACTRN12616001658404
Ethics application status
Approved
Date submitted
10/11/2016
Date registered
1/12/2016
Date last updated
10/12/2019
Date data sharing statement initially provided
10/12/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
An prospective interventional study of the incidence and severity of hypoxia in Paediatric anaesthetic care unit (PACU) using Hudson mask and heated humidified high flow nasal cannula oxygen therapy (HHHFNC)
Scientific title
A prospective interventional study of the incidence and severity of hypoxia in Paediatric anaesthetic care unit (PACU) using Hudson mask and heated humidified high flow nasal cannula oxygen therapy (HHHFNC).
Secondary ID [1] 290516 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypoxia 300922 0
Condition category
Condition code
Anaesthesiology 300911 300911 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 296510 0
Treatment: Devices
Comparator / control treatment
The control group will be patients receiving oxygen via Hudson mask.
Control group
Active

Outcomes
Primary outcome [1] 300149 0
The difference in AUC of SpO2 less than or equal to 90 % between HHHFNC and Hudson mask control group treated in the PACU.
Oxygen saturations are measured objectively and subjectively. This is to reduce the risk of measurement error from poor pulse oximeter connections. The objective measurements are drawn electronically from the PACU monitor onto study computers using data gathering software. Subjective measurement is from the observations of two research assistants who observe each study patient recover and measure any deviations in oxygen saturations equal to or below 90%.
Timepoint [1] 300149 0
Oxygen saturation levels equal to or below 90% throughout the patient's stay in the PACU. Oxygen saturation measures are recorded continuously electronically from the time the patient enters the PACU. It is discontinued at the discretion of the PACU nurse (usually when the patient is awake and moving around which makes recording by finger probe no longer possible. At this time the patient is usually ready for PACU discharge). While the patient is being monitored electronically with a finger probe, they are also monitored visually by the research nurse to look for monitor artifact caused by patient movement.
Primary outcome [2] 300150 0
The difference in AUC of SpO2 equal to or less than 85 % between HHHFNC and Hudson mask treated throughout the patients stay in PACU.
Oxygen levels are recorded electronically from a pulse oximeter probe attached to a child's finger. These measurements are collected by our study computers for analysis.
Subjective measurements supplement the objective measurements. These observations are written on a study information sheet and ultimately recorded on a Qualtrics data spreadsheet.
.
Timepoint [2] 300150 0
Oxygen saturation level below 85% any time while the patients are in PACU.
As explained above, all patients have oxygen saturations recorded continuously by digital pulse oximeter until they wake up and start moving. At that stage, they become difficult to monitor because of probe movement. Also, at that stage they are usually awake enough for discharge from the PACU. Electronic recordings occur continuously and appear on our data sheet at one second intervals.
Secondary outcome [1] 329193 0
None
Timepoint [1] 329193 0
None

Eligibility
Key inclusion criteria
Males and females, age 16 years and under admitted to PACU following anaesthesia or sedation
Minimum age
No limit
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
We found no comparable published studies which would lead to a sample size and power analysis. For this reason a preliminary audit will be conducted to establish the incidence and severity of hypoxia in this PACU. Following stage one of this pilot study, a sample size calculation will be completed by the statistician.
6.3 Statistical Methods
The AUC of SpO2 equal to or less than 90% and equal to and less than 85% will be analysed using general linear models to assess the relationship between hypoxia and HHHFNC.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
12/09/2015
Date of last participant enrolment
Anticipated
Actual
16/12/2016
Date of last data collection
Anticipated
Actual
16/12/2016
Sample size
Target
1700
Accrual to date
Final
1706
Recruitment outside Australia
Country [1] 8384 0
New Zealand
State/province [1] 8384 0
Auckland

Funding & Sponsors
Funding source category [1] 294934 0
University
Name [1] 294934 0
University of Auckland
Country [1] 294934 0
New Zealand
Funding source category [2] 294935 0
Commercial sector/Industry
Name [2] 294935 0
Fisher and Paykel Healthcare
Country [2] 294935 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 293765 0
Commercial sector/Industry
Name [1] 293765 0
Fisher and Paykel Healthcare
Address [1] 293765 0
FPHC
15 Maurice Paykel Place,
East Tamaki,
Panmure,
Auckland, New Zealand.
Country [1] 293765 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296307 0
Health and Disability Ethics Committee
Ethics committee address [1] 296307 0
Health and Disability Ethics Committees
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 296307 0
New Zealand
Date submitted for ethics approval [1] 296307 0
08/08/2015
Approval date [1] 296307 0
28/08/2015
Ethics approval number [1] 296307 0
15/STH/123
Ethics committee name [2] 296308 0
Auckland District Health Board Research Review Committee
Ethics committee address [2] 296308 0
Level 14, Support Building,
Auckland City Hospital
Private Box 92024
Grafton Auckland
New Zealand
Ethics committee country [2] 296308 0
New Zealand
Date submitted for ethics approval [2] 296308 0
17/08/2015
Approval date [2] 296308 0
23/11/2015
Ethics approval number [2] 296308 0
A+6846

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70386 0
Dr Paul Baker
Address 70386 0
Department of Paediatric Anaesthesia, Starship Children's Hospital, 2 Park Road, Grafton, Auckland 1023, New Zealand.
Postal address Private Bag 92024, Auckland 1142.
Country 70386 0
New Zealand
Phone 70386 0
+64 9 3074949, Ext 24400
Fax 70386 0
+64 9 3754368
Email 70386 0
[email protected]
Contact person for public queries
Name 70387 0
Paul Baker
Address 70387 0
Department of Paediatric Anaesthesia, Starship Children's Hospital, 2 Park Road, Grafton, Auckland 1023, New Zealand.
Postal address Private Bag 92024, Auckland 1142.
Country 70387 0
New Zealand
Phone 70387 0
+64 9 3074949, Ext 24400
Fax 70387 0
Email 70387 0
[email protected]
Contact person for scientific queries
Name 70388 0
Paul Baker
Address 70388 0
Department of Paediatric Anaesthesia, Starship Children's Hospital, 2 Park Road, Grafton, Auckland 1023, New Zealand.
Postal address Private Bag 92024, Auckland 1142.
Country 70388 0
New Zealand
Phone 70388 0
+6421977392
Fax 70388 0
Email 70388 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Under New Zealand ethics regulations, IPD cannot be shared unless they specifically approve. Also, IPD sharing would require completion of statistical analysis, approval of all authors and a two year interval following completion of the study.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6117Study protocol    Study protocol 371832-(Uploaded-02-12-2019-09-00-54)-Study-related document.docx



Results publications and other study-related documents

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