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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether apneic oxygenation can prevent dangerously low oxygen levels during intubation in newborns in the NICU. Apneic oxygenation provides oxygen through the nose without the baby breathing independently. The study compares this method to usual care, which does not include extra oxygen support during intubation. Infants at least 28 weeks old undergoing intubation in the NICU may qualify for this trial. As an unphased trial, it offers a unique opportunity to advance neonatal care techniques.

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 prior data suggests that apneic oxygenation is safe for neonatal respiratory failure?

Research has shown that apneic oxygenation during tracheal intubation in children is generally safe and well-tolerated. It helps maintain stable oxygen levels during the procedure, which is crucial because children, especially infants, can quickly experience low oxygen levels.

For instance, a review of studies found that apneic oxygenation increased the chances of successful intubation on the first attempt, suggesting it creates better conditions during the procedure. However, another study noted that it did not always prevent severe drops in oxygen levels compared to traditional methods.

Overall, apneic oxygenation is considered safe and may help maintain steady oxygen levels during intubation in infants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about apneic oxygenation for neonatal respiratory failure because it offers a novel approach to providing oxygen to newborns who are struggling to breathe. Unlike traditional methods that rely on mechanical ventilation or continuous positive airway pressure (CPAP), apneic oxygenation involves supplying oxygen during the brief pauses in breathing, potentially reducing the need for invasive procedures. This method could minimize lung injury and improve outcomes for these fragile patients by offering a gentler support system. By exploring this technique, researchers hope to enhance the safety and efficacy of respiratory support for newborns.

What evidence suggests that apneic oxygenation is effective for neonatal respiratory failure?

Research has shown that apneic oxygenation, a treatment under study in this trial, can prevent oxygen levels from dropping too low during intubation, which involves placing a tube in the airway to assist breathing. In a study conducted in a large children's ICU, apneic oxygenation reduced cases of moderate low oxygen levels (below 80%). Another study found that this method decreased low oxygen events and improved the success rate of the first intubation attempt in newborns, without causing physical instability. These findings suggest that apneic oxygenation can effectively maintain better oxygen levels in infants during the challenging process of intubation. Participants in this trial will receive either apneic oxygenation or standard care to evaluate their effectiveness in neonatal respiratory failure. ^{3 4 6 7}

Who Is on the Research Team?

Elizabeth Foglia, MD, MSCE

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7891919/

Apneic Oxygenation as a Quality Improvement Intervention ... Oxygen desaturation during TI occurs in 16–19% of TI's in the PICU. It is strongly associated with the occurrence of hemodynamic TIAEs (cardiac arrest with or ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9847056/

Effect of apneic oxygenation with intubation to reduce ... In our single center study at a large pediatric ICU, the implementation of AO was effective in reducing moderate hypoxemia (SpO2 < 80%) from ...

3. dontforgetthebubbles.com dontforgetthebubbles.com/the-kids-thrive-study/

The Kids THRIVE study: high-flow apnoeic oxygenation for ... The use of NHF did significantly not improve the rate of first attempt intubation success. When NHF is delivered to patients during apnoea it reduces that rate ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2213260025000748

Effectiveness of nasal high-flow oxygen during apnoea on ... This study confirms the previously reported reduction in hypoxaemic events and improved first-attempt success without physiological instability in neonatal ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11889762/

Apnoeic oxygenation in pediatric anesthesia: better safe ... Children, especially neonates and infants, are at particularly high risk of hypoxemia during induction of anesthesia.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0007091223006220

Apnoeic oxygenation during paediatric tracheal intubation This systematic review with meta-analysis confirms that apnoeic oxygenation during tracheal intubation of children significantly increases first-pass ...

7. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/s13054-023-04304-0

Effect of apneic oxygenation with intubation to reduce severe ... Moderate certainty evidence suggests the use of high-flow nasal cannula does not decrease hypoxia when compared with conventional oxygen therapy ...