NCT04242537

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

1.1 years

First QC Date

January 19, 2020

Last Update Submit

January 23, 2020

Conditions

Apneic Oxygenation

Outcome Measures

Primary Outcomes (2)

  • Lowest noninvasive oxygenation value

    The lowest noninvasive oxygenation value in any time between administration of sedation and/or neuromuscular blockade to successful endotracheal intubation

    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.

    With in 3 hours of the start of procedure for placement of endotracheal tube

Secondary Outcomes (4)

  • Safe Apnea Time

    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

    During the endotracheal tube placement

  • Nonhypoxia complications

    6 hours starting from the endotracheal tube placement.

  • Tube malposition

    6 hours starting from the endotracheal tube placement.

Study Arms (3)

High flow oxygen delivery

EXPERIMENTAL

Oxygen delivery with high flow nasal cannula with head side elevation to 30 degrees

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

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

Interventions

High flow nasal cannula oxygen deliveryDEVICE

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

Also known as: High Flow nasal cannula
High flow oxygen delivery
Low flow nasal cannula oxygen deliveryDEVICE

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

Also known as: Low Flow nasal cannula
Low Flow oxygen delivery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 40598378DERIVED

  • Waheed 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.

    PMID: 33199418DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator and Consultant Emergency Medicine

Study Record Dates

First Submitted

January 19, 2020

First Posted

January 27, 2020

Study Start

March 1, 2020

Primary Completion

March 30, 2021

Study Completion

March 30, 2021

Last Updated

January 27, 2020

Record last verified: 2020-01