Automatic high flow oxygen support for tiny babies during breathing tube placement – a research study
| ISRCTN | ISRCTN40770512 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40770512 |
| IRAS number | 354944 |
| Secondary identifying numbers | CPMS 67355 |
- Submission date
- 24/03/2025
- Registration date
- 07/04/2025
- Last edited
- 07/04/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Few premature babies need placement of breathing tube in the airway as a lifesaving procedure. This procedure is called intubation and one of the most difficult procedure to perform especially in a small premature baby. This procedure has low success rate, as most often the procedure is stopped. One of the main reason to stop the procedure is that baby’s oxygen and heart rate goes low during the procedure. Providing breathing support using nose prongs (called as high flow) along with automatic control of oxygen could better support the babies during the procedure and prevent low levels of oxygen. However, we do not know whether providing breathing support using “High flow” along with automatic control of oxygen is better than only providing breathing support using “High flow”. With the proposed study, we would like to compare providing breathing support using the “high flow” as compared to providing breathing support using “High flow” along with automatic control of oxygen in babies undergoing intubation procedure to study which method prevents low oxygen levels.
Who can participate?
All preterm babies born in the study center and need placement of breathing tube would be eligible.
What does the study involve?
For the eligible babies , (randomly) would either receive high flow support only or high flow support along with automatic control of oxygen during placement of breathing tube
What are the possible benefits and risks of participating?
Possible benefits: Both groups are likely to receive respiratory support of high flow during the intubation (TI) procedure. This has shown to improve the success rate of first pass intubation attempts. Also, potential to avoid the adverse events associated with multiple intubation attempts.
Possible risks:
There is no risks or burdens for the research participants. Both use of high flow and automated oxygen is commonly used in neonatal units.
All the research related procedure will be carried out by one of the research team member who is neonatal doctor or nurse.
Where is the study run from?
Study will be run from the neonatal unit, James Cook University Hospital, Middlesbrough, UK
When is the study starting and how long is it expected to run for?
January 2025 to December 2026
Who is funding the study?
VAPOTHERM (UK)
Who is the main contact?
Dr Prakash Kannan Loganathan, pkannanloganathan@nhs.net
Contact information
Public, Scientific, Principal Investigator
James Cook University Hospital, Marton Road
Middlesbrough
TS4 3BW
United Kingdom
 ORCID ID |
0000-0003-3717-8569 |
|---|---|
| Phone | +44 1642 854874 |
| pkannanloganathan@nhs.net |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | High flow with Automatic Apnoeic oxygenation for Preterm Intubations - randomised controlled trial |
| Study acronym | HAAPI |
| Study objectives | Objective: In preterm population <30 weeks birth gestational age receiving semi-elective or elective intubations (placing airway tube) whether provision of high flow automated oxygen support as compared to providing high flow support provides better cardio-respiratory stability (desaturation) and keeping the oxygen levels (Spo2) in the target range? |
| Ethics approval(s) |
Submitted 02/04/2025, West Midlands - Edgbaston Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; -; edgbaston.rec@hra.nhs.uk), ref: 25/WM/0054 |
| Health condition(s) or problem(s) studied | Preterm intubations |
| Intervention | All admitted neonates would be screened for study inclusion and exclusion criteria. For those infants who full fill the study criteria will be approached for prospective consent, whenever possible. When prospective consent not possible, recruited infants will be approached for retrospective consent. Once the decision has been made by the clinical team that a preterm infant needs placement of airway tube (TI), research team would assess the eligibility of the infant for study recruitment. If deemed eligible, Infant will be randomised 1:1 either to High flow with automated oxygen (HAAPI) or only high flow without automated oxygen HF group. Recruited infants in both groups would be placed on nasal high flow therapy of 7L/min at least 5 minutes before the procedure. We chose 7 L/min as this maximum flow rate used in our unit (unit practice). Target SpO2 for infants in both group will be 93% and oxygen (FiO2) in the HF group (standard group) would be under discretion of the attending clinical team and the infants in HAAPI group will be adjusted by the device. Infants in both groups would be connected to pulse oximetry sensor from the high flow device, which would enable us to collect continuous SpO2 and pulse rate data. Infants in both groups will also be connected to pulse oximeter sensor from the bedside monitors, which would allow the clinical team to monitor the vitals. High flow support in both groups will be continued until the procedure is completed. One of the member of the research team will collect the data contemporaneously. Study workbook provides all the data that will be collected for the study. Research team member blinded to the study randomisation and interventions will analyse the data related to primary and secondary outcomes. |
| Intervention type | Other |
| Primary outcome measure | Time to oxygen desaturate defined as drop in oxygen saturation (Spo2) by 20% from baseline for duration of the intubation attempt |
| Secondary outcome measures | 1. Total number of intubation attempts before successfully placing the breathing tube 2. Severity of desaturation: Change in baseline oxygen saturation prior to the intubation procedure to lowest Spo2 value during the intubation procedure measured using continuous pulse oximetry 3. Lowest and highest oxygen saturation (Spo2) during the procedure measured using continuous pulse oximetry 4. Proportion of time Spo2 within the target range 90-95% measured using continuous pulse oximetry 5. Proportion of time Spo2 above 95% measured using continuous pulse oximetry 6. Proportion of time oxygen saturation below 80%: Time below Spo2 80%/ Total duration of intubation procedure measured using continuous pulse oximetry |
| Overall study start date | 01/01/2025 |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Upper age limit | 30 Weeks |
| Sex | Both |
| Target number of participants | Planned Sample Size: 60; UK Sample Size: 60 |
| Key inclusion criteria | 1. Birth gestational age < 30 weeks based on mother’s last menstrual period or best obstetric estimate with first trimester ultrasound 2. Need for semi/elective intubation in the neonatal unit and the need ascertained by the neonatal team |
| Key exclusion criteria | 1. Perceived difficult airway by the medical team. 2. Previous intubation episode with more than two intubation attempts for successful intubation. 3. Delivery room intubations. 4. Emergency intubations as ascertained by the clinical team (e.g. Heart rate < 100/min, apnea at the time of procedure). 5. LISA/MIST technique of surfactant administration 6. Infants diagnosed with pneumothorax needing needle or chest tube drainage. 7. Infants with cyanotic heart disease. |
| Date of first enrolment | 01/06/2025 |
| Date of final enrolment | 30/06/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Middlesbrough
TS4 3BW
United Kingdom
Sponsor information
Hospital/treatment centre
James Cook University Hospital, Marton Road
MIddlesbrough
TS4 3BW
England
United Kingdom
| Phone | +44 1642850850 |
|---|---|
| jackie.mitchell11@nhs.net | |
| Website | http://southtees.nhs.uk/ |
"ROR" |
https://ror.org/02js17r36 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | Deidentified individual participant data will be made available, in addition to study protocols, the statistical analysis plan, and the consent form. The data will be made available upon publication to researchers who provide a methodologically sound proposal and research ethics board approval. Proposals should be submitted to pkannanloganathan@nhs.net |
Editorial Notes
24/03/2025: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
