Intubation ComplicationNCT03374046
Apneic Oxygenation in the Pediatric Intensive Care Unit
A study testing Apneic Oxygenation in people with Intubation Complication, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of the study is to determine the impact of apneic oxygenation on the time to desaturation in pediatric patients treated in a pediatric intensive care unit (PICU). The investigators hypothesize pediatric patients will have an increase in time to desaturation with apneic oxygenation when compared to standard… Read more about this study
- Who is it for?
- Ages 0 days to 17 years
- Conditions the study is for
- Intubation Complication
- What is being tested?
- Apneic Oxygenation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Dec 2017to 1 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Treated in the PICU at ACH-PR
- Age 0 through17 years
- Indication for emergent intubation
- Premedication with a paralytic agent resulting in apnea
Who cannot join
- No paralytic agent used
- Elective intubations
- Presence of cyanotic heart disease
- Inability to safely place nasal cannula on patient
- Nasal intubation
- Patients already enrolled in the study (prior intubation)
- Inability to randomize due to urgency of intubation
- Females who are known to be pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
About this study
The purpose of the study is to determine the impact of apneic oxygenation on the time to desaturation in pediatric patients treated in a pediatric intensive care unit (PICU). The investigators hypothesize pediatric patients will have an increase in time to desaturation with apneic oxygenation when compared to standard practice in the PICU.
Read the detailed description
Oxygen (O2) desaturation is one of the risks of intubation, especially in critically ill children with comorbidities, increased O2 consumption and decreased O2 delivery. Desaturation places patients at greater risk for dysrhythmia, hemodynamic instability, hypoxic brain injury, and death. As shown in the oxyhemoglobin dissociation curve, once oxyhemoglobin (PaO2) saturations drop to ~ 90%, there is an increased risk for precipitous desaturation.
Although many may believe there would be no gas exchange during apnea, alveoli continue to take up oxygen even without diaphragmatic movements or lung expansion. As such, the administration of oxygen during intubation (when a patient is apneic) has not been a standard practice until recently.
Recent studies in adults have shown an increase in the time to desaturation when they are given concurrent oxygen administration during an intubation attempt. This use of oxygen during intubation is referred to as apneic oxygenation.
As a result of this work, apneic oxygenation has become standard practice in many emergency departments, even with pediatric patients. Yet, in pediatric hospital units, including intensive care, this is not the standard practice and no pediatric studies have been published on this subject to date.
In the study unit apneic oxygenation is not standard during intubation. The investigators would like to evaluate its use as it has shown benefits in prior research published on adults. Most patients in the PICU are already on a source of oxygen administration prior to intubation, this source of oxygen is usually removed during the intubation attempt, when the patient is apneic and not breathing on his/her own.
Continuing oxygen administration during the apneic period, would be a minimal to no risk intervention and has only shown a benefit during the apneic period.
For this protocol:
Once a decision is made for intubation, the subject will be randomized into one of two groups:
- Control (standard practice)
- Apneic oxygenation.
Randomization: Subjects will be stratified by age (0 - 2 years and >2 - 17), randomized in blocks of 10 until the final sample size is achieved.
For all subjects, the study protocol will determine only the provision of supplemental oxygen during intubation.
Decisions regarding the intubation approach, pre-oxygenation, patient positioning, medications used, ventilation strategy, and choice of equipment will be made by the clinical team.
Because of the nature of the study intervention, clinicians and study personnel will be aware of study group assignments after randomization.
- Conditions
- Intubation Complication
- Being tested
- Apneic Oxygenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apneic OxygenationProcedure or surgery
Supplemental oxygen will be provided via nasal cannula during intubation attempt
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Standard care |
| Apneic Oxygenation Group | Experimental | During apneic period of intubation attempt, patient will be placed on nasal cannula
* If 0-2 years: 3L/min NC of 100% FiO2
* If > or = to 2 through17 years: 5L/min NC of 100% FiO2 Receives: Procedure: Apneic Oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to desaturation
To evaluate the effect of apneic oxygenation in time to desaturation (>/= 5% points from baseline O2 saturation) from the onset of apnea during intubation attempts in the PICU
Measured: Only during intubation
Secondary outcomes (1)
Number of Intubation Attempts
To compare the number of intubation attempts prior to successful intubation between children treated with apneic oxygenation compared to standard care
Measured: Only during intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start23 Dec 2017
- Primary completion1 Feb 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Intubation ComplicationStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fasiha Saeed, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374046
- Sponsor's protocol ID
- K5900309
- Status last verified
- Oct 2024
- First submitted
- 24 Oct 2017
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weingart SD, Levitan RM. Preoxygenation and prevention of desaturation during emergency airway management. Ann Emerg Med. 2012 Mar;59(3):165-75.e1. doi: 10.1016/j.annemergmed.2011.10.002. Epub 2011 Nov 3.
PubMed 22050948Taha SK, Siddik-Sayyid SM, El-Khatib MF, Dagher CM, Hakki MA, Baraka AS. Nasopharyngeal oxygen insufflation following pre-oxygenation using the four deep breath technique. Anaesthesia. 2006 May;61(5):427-30. doi: 10.1111/j.1365-2044.2006.04610.x.
PubMed 16674614Wimalasena Y, Burns B, Reid C, Ware S, Habig K. Apneic oxygenation was associated with decreased desaturation rates during rapid sequence intubation by an Australian helicopter emergency medicine service. Ann Emerg Med. 2015 Apr;65(4):371-6. doi: 10.1016/j.annemergmed.2014.11.014. Epub 2014 Dec 20.
PubMed 25536868Ramachandran SK, Cosnowski A, Shanks A, Turner CR. Apneic oxygenation during prolonged laryngoscopy in obese patients: a randomized, controlled trial of nasal oxygen administration. J Clin Anesth. 2010 May;22(3):164-8. doi: 10.1016/j.jclinane.2009.05.006.
PubMed 20400000
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apneic Oxygenation in the Pediatric Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03374046
- Acronym / sponsor ID
- K5900309
- Conditions
- Intubation Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 23 Dec 2017 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 15 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine the impact of apneic oxygenation on the time to desaturation in pediatric patients treated in a pediatric intensive care unit (PICU). The investigators hypothesize pediatric patients will have an increase in time to desaturation with apneic oxygenation when compared to standard practice in the PICU.
Detailed description
Oxygen (O2) desaturation is one of the risks of intubation, especially in critically ill children with comorbidities, increased O2 consumption and decreased O2 delivery. Desaturation places patients at greater risk for dysrhythmia, hemodynamic instability, hypoxic brain injury, and death. As shown in the oxyhemoglobin dissociation curve, once oxyhemoglobin (PaO2) saturations drop to ~ 90%, there is an increased risk for precipitous desaturation.
Although many may believe there would be no gas exchange during apnea, alveoli continue to take up oxygen even without diaphragmatic movements or lung expansion. As such, the administration of oxygen during intubation (when a patient is apneic) has not been a standard practice until recently.
Recent studies in adults have shown an increase in the time to desaturation when they are given concurrent oxygen administration during an intubation attempt. This use of oxygen during intubation is referred to as apneic oxygenation.
As a result of this work, apneic oxygenation has become standard practice in many emergency departments, even with pediatric patients. Yet, in pediatric hospital units, including intensive care, this is not the standard practice and no pediatric studies have been published on this subject to date.
In the study unit apneic oxygenation is not standard during intubation. The investigators would like to evaluate its use as it has shown benefits in prior research published on adults. Most patients in the PICU are already on a source of oxygen administration prior to intubation, this source of oxygen is usually removed during the intubation attempt, when the patient is apneic and not breathing on his/her own.
Continuing oxygen administration during the apneic period, would be a minimal to no risk intervention and has only shown a benefit during the apneic period.
For this protocol:
Once a decision is made for intubation, the subject will be randomized into one of two groups:
- Control (standard practice)
- Apneic oxygenation.
Randomization: Subjects will be stratified by age (0 - 2 years and >2 - 17), randomized in blocks of 10 until the final sample size is achieved.
For all subjects, the study protocol will determine only the provision of supplemental oxygen during intubation.
Decisions regarding the intubation approach, pre-oxygenation, patient positioning, medications used, ventilation strategy, and choice of equipment will be made by the clinical team.
Because of the nature of the study intervention, clinicians and study personnel will be aware of study group assignments after randomization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Standard care |
| Apneic Oxygenation Group | Experimental | Procedure: Apneic OxygenationDuring apneic period of intubation attempt, patient will be placed on nasal cannula * If 0-2 years: 3L/min NC of 100% FiO2 * If > or = to 2 through17 years: 5L/min NC of 100% FiO2 |
Who may qualify
- Ages
- 0 days to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Treated in the PICU at ACH-PR
- Age 0 through17 years
- Indication for emergent intubation
- Premedication with a paralytic agent resulting in apnea
Key exclusion criteria (8 listed)
- No paralytic agent used
- Elective intubations
- Presence of cyanotic heart disease
- Inability to safely place nasal cannula on patient
- Nasal intubation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apneic OxygenationSupplemental oxygen will be provided via nasal cannula during intubation attempt | Procedure or surgery | Apneic Oxygenation Group |
Primary outcome
Time to desaturation
Time frame: Only during intubation
To evaluate the effect of apneic oxygenation in time to desaturation (>/= 5% points from baseline O2 saturation) from the onset of apnea during intubation attempts in the PICU
1 secondary outcome
Number of Intubation Attempts
Time frame: Only during intubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Background: PubMed 22050948Weingart SD, Levitan RM. Preoxygenation and prevention of desaturation during emergency airway management. Ann Emerg Med. 2012 Mar;59(3):165-75.e1. doi: 10.1016/j.annemergmed.2011.10.002. Epub 2011 Nov 3.
- Background: PubMed 16674614Taha SK, Siddik-Sayyid SM, El-Khatib MF, Dagher CM, Hakki MA, Baraka AS. Nasopharyngeal oxygen insufflation following pre-oxygenation using the four deep breath technique. Anaesthesia. 2006 May;61(5):427-30. doi: 10.1111/j.1365-2044.2006.04610.x.
- Background: PubMed 25536868Wimalasena Y, Burns B, Reid C, Ware S, Habig K. Apneic oxygenation was associated with decreased desaturation rates during rapid sequence intubation by an Australian helicopter emergency medicine service. Ann Emerg Med. 2015 Apr;65(4):371-6. doi: 10.1016/j.annemergmed.2014.11.014. Epub 2014 Dec 20.
- Background: PubMed 20400000Ramachandran SK, Cosnowski A, Shanks A, Turner CR. Apneic oxygenation during prolonged laryngoscopy in obese patients: a randomized, controlled trial of nasal oxygen administration. J Clin Anesth. 2010 May;22(3):164-8. doi: 10.1016/j.jclinane.2009.05.006.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fasiha Saeed, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apneic Oxygenation in people with Intubation Complication, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to desaturation (time frame: Only during intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03374046, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.