Apneic Oxygenation for Neonatal Respiratory Failure

(POINT Trial)

Overseen By Elizabeth Foglia, MD, MSCE

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Airway anomaly, Unstable hemodynamics, Cyanotic heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: During intubation procedure

110 Participants Needed

Trial Summary

What is the purpose of this trial?

Tracheal intubation in the NICU is frequently complicated by severe oxygen desaturation. Apneic oxygenation, a method of applying free flowing oxygen via nasal cannula to apneic patients undergoing intubation, prevents or delays oxygen desaturation during intubation in adults and older children. We propose to enroll patients at two sites (Hospital of the University of Pennsylvania and Children's Hospital of Philadelphia) in a randomized trial in infants undergoing intubation in the NICU to determine if apneic oxygenation, compared with no respiratory support or oxygen during laryngoscopy and intubation attempts (standard care), reduces the magnitude of oxygen desaturation during tracheal intubation encounters.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, pre-medication, including paralytics, is administered as part of the trial.

What data supports the idea that Apneic Oxygenation for Neonatal Respiratory Failure is an effective treatment?

The available research shows that Apneic Oxygenation, specifically using the THRIVE method, can effectively delay the drop in oxygen levels during periods when breathing stops. Studies have demonstrated that THRIVE can extend the time a person can go without breathing while maintaining safe oxygen levels. For example, in one study, THRIVE was able to maintain oxygen levels for 40 minutes in a patient with a blocked airway. This suggests that THRIVE is effective in keeping oxygen levels stable during critical times, which is important for treating respiratory failure. ^{1 2 3 4 5}

What safety data exists for apneic oxygenation in neonatal respiratory failure?

The safety data for apneic oxygenation, specifically using Transnasal Humidified Rapid Insufflation Ventilatory Exchange (THRIVE), indicates that it is effective in prolonging apneic oxygenation without significant complications. Studies, including randomized controlled trials and reviews, have shown that THRIVE can safely extend the safe apnoea time in children and adults during procedures, with no significant adverse events reported. However, most studies are observational, and further research is needed to determine its safety in specific populations and settings. ^{1 2 3 6 7}

Is the treatment Apneic Oxygenation a promising treatment for Neonatal Respiratory Failure?

Yes, Apneic Oxygenation, also known as THRIVE, is a promising treatment. It helps delay the drop in oxygen levels during periods when breathing stops, making it safer for infants and children during medical procedures. ^{1 2 3 8 9}

Research Team

Elizabeth Foglia, MD, MSCE

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for infants at least 28 weeks corrected gestational age who need a breathing tube inserted in the NICU and have received pre-medication. It's not for babies previously enrolled, with certain health conditions like unstable blood pressure, specific heart or lung problems, COVID-19, or those intubated by non-NICU providers.

Inclusion Criteria

Babies who are at least 28 weeks old based on their expected due date.

You have taken medication before the study.

Being on a breathing machine in the NICU.

Exclusion Criteria

Previous enrollment in the trial

You have a tracheostomy.

You cannot reach a level of 90% oxygen in your blood before needing a breathing tube.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Through study completion, an average of 18 months

Treatment

Participants undergo intubation with either apneic oxygenation or standard care to assess oxygen desaturation

During intubation procedure

Follow-up

Participants are monitored for safety outcomes such as adverse events and nasal trauma

Within 24 hours of procedure

Treatment Details

Interventions

• Apneic Oxygenation
• Standard of Care

Trial Overview The study tests if giving oxygen through the nose (apneic oxygenation) to babies who can't breathe on their own during intubation is better than the usual method without extra oxygen. Infants are randomly chosen to receive either apneic oxygenation or standard care at two hospitals.

Participant Groups

Group I: Apneic Oxygenation Experimental Treatment 1 Intervention

Group II: Standard of Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

In a study involving 60 children aged 1-6 years undergoing anesthesia, THRIVE with 100% oxygen did not significantly extend safe apnoea time compared to low-flow 100% oxygen, with median apnoea times of 7.6 minutes for THRIVE and 6.9 minutes for low-flow.

THRIVE with 30% oxygen resulted in significantly shorter apnoea times (3.0 minutes), indicating that higher flow rates of lower oxygen concentrations may not be effective for prolonging safe apnoea time in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transnasal humidified rapid insufflation ventilatory exchange for oxygenation of children during apnoea: a prospective randomised controlled trial. Riva, T., Pedersen, TH., Seiler, S., et al.[2019]

In a study of 10 adult patients undergoing direct laryngoscopy, the use of transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) significantly prolonged the time to desaturation to <90% during apnoea compared to traditional preoxygenation methods, with Group H maintaining nearly 100% saturation even after 12 minutes of apnoea.

Patients using THRIVE had a higher arterial oxygen partial pressure (PaO2) and increased carbon dioxide levels (PaCO2) after 6 minutes of apnoea, indicating that THRIVE not only delays desaturation but also maintains better oxygenation during prolonged apnoea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of transnasal humidified rapid-insufflation ventilatory exchange versus traditional preoxygenation followed by apnoeic oxygenation in delaying desaturation during apnoea: A preliminary study. Rajan, S., Joseph, N., Tosh, P., et al.[2022]

In a study involving 48 healthy children, the use of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) significantly prolonged safe apnoea time compared to standard jaw support, with THRIVE maintaining transcutaneous haemoglobin saturation at 99.6%.

While THRIVE improved apnoeic oxygenation duration, it did not enhance CO2 clearance, indicating that while it is effective for oxygenation, it may not address all aspects of respiratory management during apnoea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) in children: a randomized controlled trial. Humphreys, S., Lee-Archer, P., Reyne, G., et al.[2018]

THRIVE, a technique using high-flow humidified nasal oxygen, effectively extended apnea time and maintained oxygen saturation in a 35-year-old man during a critical airway emergency.

In this case, THRIVE successfully kept oxygen levels stable for 40 minutes during sedation-induced hypoventilation, demonstrating its potential as a life-saving intervention in compromised airway situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange for Emergent Surgical Tracheostomy: A Case Report. Desai, N., Fowler, A.[2022]

In a study of 14 adult patients undergoing esophageal surgery, 92.9% maintained adequate oxygenation throughout the procedure using transnasal humidified rapid insufflation ventilatory exchange (THRIVE), demonstrating its safety and efficacy as an apneic oxygenation method.

The study found that while THRIVE is generally effective, patients with a history of smoking and higher body mass index (BMI) may face increased risks of oxygen desaturation, highlighting the need for careful monitoring in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transnasal Humidified Rapid Insufflation Ventilatory Exchange in Endoscopic Esophageal Surgery. Yang, ZM., Loh, TH., Ross, J., et al.[2023]

The Kids THRIVE trial is a multicenter randomized controlled trial involving 960 children aged 0-16 years, designed to test whether Transnasal Humidified Rapid Insufflation Ventilatory Exchange (THRIVE) can reduce hypoxemic events during emergency intubation compared to standard care.

The primary outcomes focus on the incidence of hypoxemia (SpO2 <90%) during intubation and the success rate of the first intubation attempt without hypoxemia, highlighting the importance of both patient and operator factors in this high-risk procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transnasal Humidified Rapid Insufflation Ventilatory Exchange in children requiring emergent intubation (Kids THRIVE): a protocol for a randomised controlled trial. George, S., Humphreys, S., Williams, T., et al.[2020]

Transnasal humidified rapid insufflation ventilatory exchange (THRIVE) is effective for providing oxygenation during apneic periods in patients undergoing laryngopharyngeal surgeries, with median apnea times reported between 13 and 27 minutes.

The review of 15 studies found no significant complications associated with THRIVE, indicating it is a safe technique for short procedures, although further research is needed to explore its limitations in specific populations and in combination with other surgical techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the use of transnasal humidified rapid insufflation ventilatory exchange for patients undergoing surgery in the shared airway setting. Huang, L., Dharmawardana, N., Badenoch, A., et al.[2022]

Nasal high flow oxygen delivery is effective for maintaining oxygenation in spontaneously breathing children with abnormal airways during anesthesia, as demonstrated in a study of 20 pediatric patients aged 5 days to 11 years.

The technique showed a high average oxygen saturation (96%) with only one case requiring rescue oxygenation, indicating its safety and efficacy for procedures like tubeless airway surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nasal high-flow oxygen delivery in children with abnormal airways. Humphreys, S., Rosen, D., Housden, T., et al.[2018]

In a study of 79 children aged 1 day to 15 years undergoing rapid sequence induction intubation, 88.6% did not experience arterial oxygen desaturation when using transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) during the apnoeic period.

Desaturation was more common in children under 1 year of age and those with difficult intubations, suggesting that THRIVE is effective but may have limitations in specific high-risk groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transnasal humidified rapid-insufflation ventilatory exchange during rapid sequence induction in children. Ayanmanesh, F., Abdat, R., Jurine, A., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Transnasal humidified rapid insufflation ventilatory exchange for oxygenation of children during apnoea: a prospective randomised controlled trial. [2019]

2. India pubmed.ncbi.nlm.nih.gov

Effectiveness of transnasal humidified rapid-insufflation ventilatory exchange versus traditional preoxygenation followed by apnoeic oxygenation in delaying desaturation during apnoea: A preliminary study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) in children: a randomized controlled trial. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Use of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange for Emergent Surgical Tracheostomy: A Case Report. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Transnasal Humidified Rapid Insufflation Ventilatory Exchange in Endoscopic Esophageal Surgery. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Transnasal Humidified Rapid Insufflation Ventilatory Exchange in children requiring emergent intubation (Kids THRIVE): a protocol for a randomised controlled trial. [2020]

7. Japan pubmed.ncbi.nlm.nih.gov

A review of the use of transnasal humidified rapid insufflation ventilatory exchange for patients undergoing surgery in the shared airway setting. [2022]

8. France pubmed.ncbi.nlm.nih.gov

Nasal high-flow oxygen delivery in children with abnormal airways. [2018]

9. France pubmed.ncbi.nlm.nih.gov

Transnasal humidified rapid-insufflation ventilatory exchange during rapid sequence induction in children. [2021]