Apneic OxygenationApOxEDNCT04242537
Apneic Oxygenation in the Emergency Department
A study testing High flow nasal cannula oxygen delivery and Low flow nasal cannula oxygen delivery in people with Apneic Oxygenation, run by Aga Khan University Hospital, Pakistan.
Trial summary
Apneic oxygenation is a process of delivering continuous oxygen during direct laryngoscopy. Nasal cannulas are used for the purpose of oxygenation; for delivering either low flow or high flow oxygen but haven't been tested in terms of a superior study design on improving patient outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Apneic Oxygenation
- What is being tested?
- High flow nasal cannula oxygen delivery and Low flow nasal cannula oxygen delivery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2020to 30 Mar 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (18 years and above) requiring endotracheal intubation in the emergency department.
- Intubation performed by the emergency medicine physician who are post graduate trainee year IV and above. The year IV and above cut off is taken because at this time the trainees have done more than 20 endotracheal intubations. The operators are assessed through direct supervision and confirmation through filing of their procedural log books
Who cannot join
- Supervisor or operator feels specific intra-procedural oxygenation technique will be required.
- Patients presenting with cardiac arrest
- Pregnant patients (as the patients are at risk of aspiration and high oxygen delivery can have bad outcomes on the fetus)
- Patients with 'Do not resuscitate' order.
- Morbidly obese on assessment as such patient may need pre intubation preparation of the head side and more controlled settings.
- Patient who are shifted from another hospital post intubation
Show all 11Show fewer
- Patients with interstitial lung disease or lung tumor
- Neck trauma (expanding neck hematoma)
- Neck and Oral cavity cancers, or patients with cancers of the neck and oral cavity who have undergone surgery, post radiation of the neck and oral cavity cancers.
- Pulse oximetry <90% in ambient air.
- Body mass index > 35kg/m2
About this study
Official title: A Randomized Control Trial to Assess the Effectiveness of Apneic Oxygenation in Adults Using Low Flow or High Flow Nasal Cannula With Head Side Elevation Compared With Usual Care to Prevent Desaturation During Endotracheal Intubation
Apneic oxygenation is a process of delivering continuous oxygen during direct laryngoscopy. Nasal cannulas are used for the purpose of oxygenation; for delivering either low flow or high flow oxygen but haven't been tested in terms of a superior study design on improving patient outcomes. In this study the investigators propose to assess the effect of giving low flow oxygen with head side elevation versus high flow oxygen with head side elevation against the usual practice of care in which no oxygen is provided during direct laryngoscopy on participant's oxygenation level. This will be a three arm study instituting block randomization technique. There will be no blinding due to the nature of intervention. The primary outcomes are lowest non-invasive oxygen saturation measurement during direct laryngoscopy and two minutes after the placement of the tube and first pass success rate. The intervention is unique as the investigators have introduced head side elevation up to 30 degrees for improving glottis visualization and low or high flow oxygen delivery on grounds to improve oxygenation for patient safety undergoing endotracheal intubation. The technique if proved successful can be employed as a method of airway management in the emergency room. The results of the study will open new horizons for the development of guidelines to utilize it as a routine measure, during airway management in the emergency room.
Read the detailed description
Intervention (High Flow and Low Flow):
The participants after fulfilling the eligibility criteria will be randomly assigned to the respective arm (High Flow, Low Flow or Standard). For procedure, depending upon the arm, the head side of the patient bed will be elevated up to 30 degrees in order to better visualize the glottis. The participants in the high flow oxygen delivery through nasal cannula preoxygenation will be set for 4 min at 6 L/min through humidified and heated pure oxygen (fraction of inspired oxygen 100%, 37C). Similarly, participant in the low flow oxygen delivery through nasal cannula preoxygenation will be set for 4 min at 3 L/min through humidified and heated pure oxygen (faction of inspired oxygen 100%, 37C). Throughout the procedure the high flow nasal cannula or low flow nasal cannula will be maintained trying to achieve a continuous oxygen during direct laryngoscopy for RSI.
Standard Arm:
In the standard arm the head end of the bed will not be raised to 30 degrees instead the whole bed is raised up to the operator belly button in order to ease glottis visualization. In the standard group the preoxygenation is for 4 min or till achievement of peripheral oxygen saturation greater than 95% with a face mask that will be connected to the oxygen port at 10 L/min. During the direct laryngoscopy there will be no insufflation of oxygen through nasal cannula or face mask.
Data collection:
Research staff involved in collecting data, will be independent from primary research team in order to minimize observer bias. The oxygen saturations will be recorded using pulse oximetry (through a standard infrared oximetry tape) exclusively used for research purpose and will record time using stop watch (Casio Digital Stop Watch) during and after the procedure. The operator will report research staff about all subjective assessments of difficult intubation and airway complications during procedure on the data collection tool. The operator while performing the direct laryngoscopy, if experience difficulty as per Corkman Lehman grade, will inform research staff for protocol deviation.
Intubation attempts (number of time laryngoscope blade placed in the mouth) will be counted for each patient. In those patients where first pass is failed and subsequent attempt is made without assisted ventilation, the apnea time will be noted as mentioned above. To confirm the accuracy of data collected, the investigators will conduct a concurrent assessment of the outcomes for a convenience sample of 10% of enrolled participants.
- Conditions
- Apneic Oxygenation
- Being tested
- High flow nasal cannula oxygen delivery, Low flow nasal cannula oxygen delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow nasal cannula oxygen deliveryDevice
Also called High Flow nasal cannula
It includes the delivery of oxygen through a high flow nasal cannula with head side elevation to 30 degrees to prevent desaturation and improve first pass success rate of endotracheal intubation
Low flow nasal cannula oxygen deliveryDevice
Also called Low Flow nasal cannula
It includes the delivery of oxygen through a low flow nasal cannula coupled with head side elevation to 30 degrees to prevent desaturation and improve first pass success rate of endotracheal intubation
| Study group | Role | What they receive |
|---|---|---|
| High flow oxygen delivery | Experimental | Oxygen delivery with high flow nasal cannula with head side elevation to 30 degrees Receives: Device: High flow nasal cannula oxygen delivery |
| Low Flow oxygen delivery | Experimental | Low flow oxygen delivery through nasal cannula with head side elevation to 30 degrees Receives: Device: Low flow nasal cannula oxygen delivery |
| Standard practice of care | No intervention | No oxygen delivery either high flow or low flow through nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lowest noninvasive oxygenation value
The lowest noninvasive oxygenation value in any time between administration of sedation and/or neuromuscular blockade to successful endotracheal intubation
Measured: Within 3 hours, beginning from the administration of the sedation or the neuromuscular blocker till the placement of the endotracheal tube
First pass success rate
Single successful attempt for the placement of endotracheal tube in the trachea during direct laryngoscopy and subsequent confirmation.
Measured: With in 3 hours of the start of procedure for placement of endotracheal tube
Secondary outcomes (4)
Safe Apnea Time
the time from the administration of sedation and/or neuromuscular blockade to success to successful endotracheal intubation (safe apnea time)
Measured: With in 3 hours beginning from the administration of the sedation and or neuromuscular blockade drug to the placement of the endotracheal tube
Direct laryngoscopy grades
Grade of largyogoscopic view as per Corkman Lehane Laryngoscopic grades (Grade I to IV) on first attempt.
Measured: During the endotracheal tube placement
Nonhypoxia complications
Incidence of non-hypoxia complications (e.g. arrhythmia, hypotension, tracheal rupture, vocal cord injury)
Measured: 6 hours starting from the endotracheal tube placement.
Tube malposition
Incidence of post-intubation tube malposition on Chest X ray
Measured: 6 hours starting from the endotracheal tube placement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Mar 2020 (estimated)
- Primary completion30 Mar 2021 (estimated)
- Study completion30 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Apneic OxygenationStudies of the same condition, open and under way.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahan Waheed, Aga Khan University Hospital, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242537
- Sponsor's protocol ID
- 192002ER-PK
- Acronym
- ApOxED
- Status last verified
- Jan 2020
- First submitted
- 19 Jan 2020
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Waheed S, Kapadia NN, Jawed DR, Raheem A, Khan MF. Randomized controlled trial to assess the effectiveness of apnoeic oxygenation in adults using a low-flow or high-flow nasal cannula with head side elevation during endotracheal intubation in the emergency department. BMC Res Notes. 2025 Jul 1;18(1):264. doi: 10.1186/s13104-025-07328-7.
PubMed 40598378Waheed S, Kapadia NN, Khan MF, Kerai SM, Raheem A, Naeem R. Randomised controlled trial to assess the effectiveness of apnoeic oxygenation in adults using low-flow or high-flow nasal cannula with head side elevation versus usual care to prevent desaturation during endotracheal intubation in the emergency department (ApOxED): study protocol. BMJ Open. 2020 Nov 16;10(11):e037964. doi: 10.1136/bmjopen-2020-037964.
PubMed 33199418
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial to Assess the Effectiveness of Apneic Oxygenation in Adults Using Low Flow or High Flow Nasal Cannula With Head Side Elevation Compared With Usual Care to Prevent Desaturation During Endotracheal Intubation
- ClinicalTrials.gov ID
- NCT04242537
- Acronym / sponsor ID
- ApOxED / 192002ER-PK
- Conditions
- Apneic Oxygenation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Aga Khan University Hospital, PakistanUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 30 Mar 2021 (estimated)
- First posted
- 27 Jan 2020 (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.
Apneic oxygenation is a process of delivering continuous oxygen during direct laryngoscopy. Nasal cannulas are used for the purpose of oxygenation; for delivering either low flow or high flow oxygen but haven't been tested in terms of a superior study design on improving patient outcomes. In this study the investigators propose to assess the effect of giving low flow oxygen with head side elevation versus high flow oxygen with head side elevation against the usual practice of care in which no oxygen is provided during direct laryngoscopy on participant's oxygenation level. This will be a three arm study instituting block randomization technique. There will be no blinding due to the nature of intervention. The primary outcomes are lowest non-invasive oxygen saturation measurement during direct laryngoscopy and two minutes after the placement of the tube and first pass success rate. The intervention is unique as the investigators have introduced head side elevation up to 30 degrees for improving glottis visualization and low or high flow oxygen delivery on grounds to improve oxygenation for patient safety undergoing endotracheal intubation. The technique if proved successful can be employed as a method of airway management in the emergency room. The results of the study will open new horizons for the development of guidelines to utilize it as a routine measure, during airway management in the emergency room.
Detailed description
Intervention (High Flow and Low Flow):
The participants after fulfilling the eligibility criteria will be randomly assigned to the respective arm (High Flow, Low Flow or Standard). For procedure, depending upon the arm, the head side of the patient bed will be elevated up to 30 degrees in order to better visualize the glottis. The participants in the high flow oxygen delivery through nasal cannula preoxygenation will be set for 4 min at 6 L/min through humidified and heated pure oxygen (fraction of inspired oxygen 100%, 37C). Similarly, participant in the low flow oxygen delivery through nasal cannula preoxygenation will be set for 4 min at 3 L/min through humidified and heated pure oxygen (faction of inspired oxygen 100%, 37C). Throughout the procedure the high flow nasal cannula or low flow nasal cannula will be maintained trying to achieve a continuous oxygen during direct laryngoscopy for RSI.
Standard Arm:
In the standard arm the head end of the bed will not be raised to 30 degrees instead the whole bed is raised up to the operator belly button in order to ease glottis visualization. In the standard group the preoxygenation is for 4 min or till achievement of peripheral oxygen saturation greater than 95% with a face mask that will be connected to the oxygen port at 10 L/min. During the direct laryngoscopy there will be no insufflation of oxygen through nasal cannula or face mask.
Data collection:
Research staff involved in collecting data, will be independent from primary research team in order to minimize observer bias. The oxygen saturations will be recorded using pulse oximetry (through a standard infrared oximetry tape) exclusively used for research purpose and will record time using stop watch (Casio Digital Stop Watch) during and after the procedure. The operator will report research staff about all subjective assessments of difficult intubation and airway complications during procedure on the data collection tool. The operator while performing the direct laryngoscopy, if experience difficulty as per Corkman Lehman grade, will inform research staff for protocol deviation.
Intubation attempts (number of time laryngoscope blade placed in the mouth) will be counted for each patient. In those patients where first pass is failed and subsequent attempt is made without assisted ventilation, the apnea time will be noted as mentioned above. To confirm the accuracy of data collected, the investigators will conduct a concurrent assessment of the outcomes for a convenience sample of 10% of enrolled participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High flow oxygen delivery | Experimental | Device: High flow nasal cannula oxygen deliveryOxygen delivery with high flow nasal cannula with head side elevation to 30 degrees |
| Low Flow oxygen delivery | Experimental | Device: Low flow nasal cannula oxygen deliveryLow flow oxygen delivery through nasal cannula with head side elevation to 30 degrees |
| Standard practice of care | No intervention | –No oxygen delivery either high flow or low flow through nasal cannula |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (18 years and above) requiring endotracheal intubation in the emergency department.
- Intubation performed by the emergency medicine physician who are post graduate trainee year IV and above. The year IV and above cut off is taken because at this time the trainees have done more than 20 endotracheal intubations. The operators are assessed through direct supervision and confirmation through filing of their procedural log books
Key exclusion criteria (11 listed)
- Supervisor or operator feels specific intra-procedural oxygenation technique will be required.
- Patients presenting with cardiac arrest
- Pregnant patients (as the patients are at risk of aspiration and high oxygen delivery can have bad outcomes on the fetus)
- Patients with 'Do not resuscitate' order.
- Morbidly obese on assessment as such patient may need pre intubation preparation of the head side and more controlled settings.
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 |
|---|---|---|
| High flow nasal cannula oxygen deliveryAlso: High Flow nasal cannulaIt includes the delivery of oxygen through a high flow nasal cannula with head side elevation to 30 degrees to prevent desaturation and improve first pass success rate of endotracheal intubation | Device | High flow oxygen delivery |
| Low flow nasal cannula oxygen deliveryAlso: Low Flow nasal cannulaIt includes the delivery of oxygen through a low flow nasal cannula coupled with head side elevation to 30 degrees to prevent desaturation and improve first pass success rate of endotracheal intubation | Device | Low Flow oxygen delivery |
Primary outcome
Lowest noninvasive oxygenation value
Time frame: Within 3 hours, beginning from the administration of the sedation or the neuromuscular blocker till the placement of the endotracheal tube
The lowest noninvasive oxygenation value in any time between administration of sedation and/or neuromuscular blockade to successful endotracheal intubation
First pass success rate
Time frame: With in 3 hours of the start of procedure for placement of endotracheal tube
Single successful attempt for the placement of endotracheal tube in the trachea during direct laryngoscopy and subsequent confirmation.
4 secondary outcomes
Safe Apnea Time
Time frame: With in 3 hours beginning from the administration of the sedation and or neuromuscular blockade drug to the placement of the endotracheal tube
Direct laryngoscopy grades
Time frame: During the endotracheal tube placement
Nonhypoxia complications
Time frame: 6 hours starting from the endotracheal tube placement.
Tube malposition
Time frame: 6 hours starting from the endotracheal tube placement.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Derived from this study: PubMed 40598378Waheed S, Kapadia NN, Jawed DR, Raheem A, Khan MF. Randomized controlled trial to assess the effectiveness of apnoeic oxygenation in adults using a low-flow or high-flow nasal cannula with head side elevation during endotracheal intubation in the emergency department. BMC Res Notes. 2025 Jul 1;18(1):264. doi: 10.1186/s13104-025-07328-7.
- Derived from this study: PubMed 33199418Waheed S, Kapadia NN, Khan MF, Kerai SM, Raheem A, Naeem R. Randomised controlled trial to assess the effectiveness of apnoeic oxygenation in adults using low-flow or high-flow nasal cannula with head side elevation versus usual care to prevent desaturation during endotracheal intubation in the emergency department (ApOxED): study protocol. BMJ Open. 2020 Nov 16;10(11):e037964. doi: 10.1136/bmjopen-2020-037964.
Related trials for Apneic Oxygenation
RecruitingObservational study
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
Not yet recruiting
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
Not yet recruiting
Effect of Different-Flow High-Flow Nasal Cannula Versus Traditional Face Mask Oxygenation on Safe Apnea Time in Obese Patients
Obesity
Not yet recruiting
Sleep-Assessment in Patients Between High Altitude HA vs. Sea Level LA in Patients With Pulmonary Arterial Hypertension PAH
Pulmonary Arterial Hypertension (PAH), Pulmonary Vascular Disease
Not yet recruiting
Sleep-Assessment in Patients Between High Altitude HA vs. Sea Level LA in Healthy Individuals H
Healthy, Healthy Adult
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing High flow nasal cannula oxygen delivery and Low flow nasal cannula oxygen delivery in people with Apneic Oxygenation, run by Aga Khan University Hospital, Pakistan.
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 2 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Lowest noninvasive oxygenation value (time frame: Within 3 hours, beginning from the administration of the sedation or the neuromuscular blocker till the placement of the endotracheal tube). The study lists 2 primary outcomes in all. 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 NCT04242537, which also lists 2 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 27 Jan 2020.