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PreOxygenation for EndoTracheal Intubations (POET)

Primary Purpose

Intubation Complication, Preoxygenation, Hypoxemia

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Non-rebreather oxygen mask
Bag-valve-mask
High Flow Nasal Cannulae
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intubation Complication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with a pre-existing arterial line
  • Age > 18
  • Able to provide consent

Exclusion Criteria:

  • Acute respiratory distress Defined as RR >30, Baseline oxygen requirements >50%, current use of High Flow Nasal Cannulae or Non-invasive ventilation for respiratory support
  • Decreased level of consciousness GCS <13
  • Possible exclusion if the allocation to prespecified groups are filled
  • Contraindication for high oxygen therapy Severe Chronic Obstructive Pulmonary Disease with documented CO2 retention based on outpatient ABG History of Bleomycin use
  • Significant hemodynamic instability Lactate > 3 mmol/L Norepinephrine dose >0.2 mcg/kg/min or equivalent dose of other vasopressors

Sites / Locations

  • QEII Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

BMI <30 no lung disease

BMI <30 with lung disease

BMI 30-35 with no lung disease

BMI 30-35 with lung disease

BMI >35 with no lung disease

BMI >35 with lung disease

Arm Description

Patients with a BMI <30 with no lung disease

Patients with a BMI <30 with lung disease

Patients with a BMI between 30 and 35 with no lung disease

Patients with a BMI between 30 and 35 with lung disease

Patients with a BMI> 35 with no lung disease

Patients with a BMI> 35 with lung disease

Outcomes

Primary Outcome Measures

PaO2
Partial pressure of arterial oxygen

Secondary Outcome Measures

PaCO2
Partial pressure of arterial carbon dioxide
Patient comfort
Numeric scoring of patient comfort for each intervention

Full Information

First Posted
August 1, 2017
Last Updated
March 8, 2021
Sponsor
Nova Scotia Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT03240614
Brief Title
PreOxygenation for EndoTracheal Intubations
Acronym
POET
Official Title
PreOxygenation for Airway Management: High Flow Versus Conventional Preoxygenation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 30, 2018 (Actual)
Primary Completion Date
December 15, 2021 (Anticipated)
Study Completion Date
April 14, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Scotia Health Authority

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Hypoxemia is a life threatening complication during emergency airway management. Despite advances in technology and training, hypoxemia still occurs in up to a quarter of all intubations placing patients at high risk for damage to vital organs and death. A key method in the prevention of hypoxemia is known as preoxygenation which has been shown to decrease the incidence of hypoxemia. Currently there are two conventional methods for preoxygenation in the literature, however recently a new method has been described as a possible alternative method. What is unclear in the literature is if one modality is superior than the other for preoxygenation. The goal of this interventional study is to determine if one method of preoxygenation is superior to the other. This is a 3 arm interventional cross over designed study comparing three interventional methods for preoxygenation. Non-rebreather mask, bag-valve mask and high flow nasal cannulae.
Detailed Description
In emergency and critical care medicine, one of the most common incidences of severe hypoxemia occurs during the process of endotracheal intubations. Endotracheal intubations, also known as insertion of a breathing tube, is a life saving technique used in medicine to help maintain oxygen delivery, to protect lungs from injury, for patients to safely undergo anesthesia for surgeries, as well as to help rest critically ill patients to allow their bodies time to recover. Despite advances in the field of medicine, the process of placing a breathing tube in emergency situations is still associated with an increase risk of hypoxemia up to 26.7%. This places patients at significant risk for cardiac dysrhythmia, brain damage and hemodynamic decompensation which may ultimately result in death. A UK national review of emergency intubations identified hypoxemia as a cause of death in 50% of intensive care intubations and 27% of Emergency Department intubations. Therefore, it is imperative to improve and develop methods to minimize hypoxemia during airway management. A vital component used to minimize the risk of hypoxemia during endotracheal intubations is preoxygenation. Preoxygenation is a method to to prolong the time to oxygen desaturation by replacing the lung volume with 100% oxygen compared to 21% oxygen (room air) through the administration of supplemental oxygen. This increases the reservoir of oxygen in the lungs that the body can use to prolong their time to desaturation. Studies have shown a good preoxygenation technique can increase the time to oxygen desaturation from 0.6 min to 8 min in a non obese patient. This remarkable impact at preventing hypoxemia has made preoxygenation the gold standard to minimize hypoxemia during airway management. Historically preoxygenation with bag-valve-mask ventilation (BVM) and an oxygen non-rebreather mask has been the standard for preoxygenation. Recently, the use of high flow nasal cannulaes have been used for preoxygenation however it is unclear in the literature if one provides a superior preoxygenation compared to another. In an effort to determine the best preoxygenation modality for airway management, the investigators will conduct a 3 arm interventional crossover designed study to compare preoxygenation using a non-rebreather mask, BVM and HFNC in 150 patients. To determine which modality provides the best preoxygenation, arterial blood gases will be taken after each intervention and compared against each other. Given the high propensity for hypoxemia during airway management in the obese and disease lung population, this protocol will have specific groups based on their BMI (<30, 30-35 and >35) as well as the presence of lung disease based upon their PaO2/FiO2 ratio (< 300 lung disease or >300 no lung disease).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intubation Complication, Preoxygenation, Hypoxemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Will test preoxygenation using High Flow Nasal Cannulae, Non-rebreather mask and Bag-Valve-Mask
Masking
Outcomes Assessor
Masking Description
Interventions will be labeled using a Letter key so the analysis of the dataset by our statistician will be blinded
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BMI <30 no lung disease
Arm Type
Active Comparator
Arm Description
Patients with a BMI <30 with no lung disease
Arm Title
BMI <30 with lung disease
Arm Type
Active Comparator
Arm Description
Patients with a BMI <30 with lung disease
Arm Title
BMI 30-35 with no lung disease
Arm Type
Active Comparator
Arm Description
Patients with a BMI between 30 and 35 with no lung disease
Arm Title
BMI 30-35 with lung disease
Arm Type
Active Comparator
Arm Description
Patients with a BMI between 30 and 35 with lung disease
Arm Title
BMI >35 with no lung disease
Arm Type
Active Comparator
Arm Description
Patients with a BMI> 35 with no lung disease
Arm Title
BMI >35 with lung disease
Arm Type
Active Comparator
Arm Description
Patients with a BMI> 35 with lung disease
Intervention Type
Device
Intervention Name(s)
Non-rebreather oxygen mask
Intervention Description
This intervention will be preoxygenation using a Non-rebreather that will be placed upon the participant for preoxygenation. The oxygen flow will be set at 60 L/min and the participant will be preoxygenated for a total of 3 minutes. After 3 minutes, an ABG will be taken and labeled as Intervention A.
Intervention Type
Device
Intervention Name(s)
Bag-valve-mask
Intervention Description
This intervention will be preoxygenation using a BVM apparatus for preoxygenation for 3 minutes. At the end of 3 minutes an ABG will be obtained.
Intervention Type
Device
Intervention Name(s)
High Flow Nasal Cannulae
Intervention Description
This intervention will be preoxygenation using High Flow Nasal Cannulaes at an FiO2 of 100%. The oxygen flow will be set at 60 L/min and the participant will be preoxygenated for a total of 3 minutes. After the 3 minutes, an ABG will be taken and labeled as Intervention C.
Primary Outcome Measure Information:
Title
PaO2
Description
Partial pressure of arterial oxygen
Time Frame
An ABG will be taken 3 min after preoxygenation in the NRB and HFNC group. The ABG will be taken once the ETO2 is >85% in the BVM group. Pooled data will be collected at the conclusion of the study to be analyzed within 6 months of completion.
Secondary Outcome Measure Information:
Title
PaCO2
Description
Partial pressure of arterial carbon dioxide
Time Frame
An ABG will be taken 3 min after preoxygenation in the NRB and HFNC group. The ABG will be taken once the ETO2 is >85% in the BVM group. Pooled data will be collected at the conclusion of the study to be analyzed within 6 months of completion.
Title
Patient comfort
Description
Numeric scoring of patient comfort for each intervention
Time Frame
At the conclusion of all interventions the data will be collected on each individual participant. Pooled data will be collected at the conclusion of the study to be analyzed within 6 months of completion.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with a pre-existing arterial line Age > 18 Able to provide consent Exclusion Criteria: Acute respiratory distress Defined as RR >30, Baseline oxygen requirements >50%, current use of High Flow Nasal Cannulae or Non-invasive ventilation for respiratory support Decreased level of consciousness GCS <13 Possible exclusion if the allocation to prespecified groups are filled Contraindication for high oxygen therapy Severe Chronic Obstructive Pulmonary Disease with documented CO2 retention based on outpatient ABG History of Bleomycin use Significant hemodynamic instability Lactate > 3 mmol/L Norepinephrine dose >0.2 mcg/kg/min or equivalent dose of other vasopressors
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edmund Tan, MD
Phone
902-473-4455
Email
cetan@dal.ca
Facility Information:
Facility Name
QEII Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3G1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chong-How E Tan
Phone
9024888082
Email
cetan@dal.ca

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25548602
Citation
Gebremedhn EG, Mesele D, Aemero D, Alemu E. The incidence of oxygen desaturation during rapid sequence induction and intubation. World J Emerg Med. 2014;5(4):279-85. doi: 10.5847/wjem.j.issn.1920-8642.2014.04.007.
Results Reference
background
PubMed Identifier
21447489
Citation
Cook TM, Woodall N, Harper J, Benger J; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 2: intensive care and emergency departments. Br J Anaesth. 2011 May;106(5):632-42. doi: 10.1093/bja/aer059. Epub 2011 Mar 29.
Results Reference
background
PubMed Identifier
19399574
Citation
Tanoubi I, Drolet P, Donati F. Optimizing preoxygenation in adults. Can J Anaesth. 2009 Jun;56(6):449-66. doi: 10.1007/s12630-009-9084-z. Epub 2009 Apr 28.
Results Reference
background
PubMed Identifier
22050948
Citation
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.
Results Reference
background

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PreOxygenation for EndoTracheal Intubations

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