PreOxygenation for EndoTracheal Intubations

NCT03240614 | Terminated

• 1 other identifier: POET1
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation Complication; Preoxygenation; Hypoxemia

Outcome Measures

Primary Outcomes (1)

• PaO2

  Partial pressure of arterial oxygen

  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 Outcomes (2)

• PaCO2

  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.

• Patient comfort

  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.

Study Arms (6)

BMI <30 no lung disease

ACTIVE COMPARATOR

Patients with a BMI \<30 with no lung disease

Device: Non-rebreather oxygen mask; Device: Bag-valve-mask; Device: High Flow Nasal Cannulae

BMI <30 with lung disease

ACTIVE COMPARATOR

Patients with a BMI \<30 with lung disease

Device: Non-rebreather oxygen mask; Device: Bag-valve-mask; Device: High Flow Nasal Cannulae

BMI 30-35 with no lung disease

ACTIVE COMPARATOR

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

Device: Non-rebreather oxygen mask; Device: Bag-valve-mask; Device: High Flow Nasal Cannulae

BMI 30-35 with lung disease

ACTIVE COMPARATOR

Patients with a BMI between 30 and 35 with lung disease

Device: Non-rebreather oxygen mask; Device: Bag-valve-mask; Device: High Flow Nasal Cannulae

BMI >35 with no lung disease

ACTIVE COMPARATOR

Patients with a BMI\> 35 with no lung disease

Device: Non-rebreather oxygen mask; Device: Bag-valve-mask; Device: High Flow Nasal Cannulae

BMI >35 with lung disease

ACTIVE COMPARATOR

Patients with a BMI\> 35 with lung disease

Device: Non-rebreather oxygen mask; Device: Bag-valve-mask; Device: High Flow Nasal Cannulae

Interventions

Non-rebreather oxygen mask DEVICE

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.

BMI 30-35 with lung disease; BMI 30-35 with no lung disease; BMI <30 no lung disease; BMI <30 with lung disease; BMI >35 with lung disease; BMI >35 with no lung disease

Bag-valve-mask DEVICE

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.

BMI 30-35 with lung disease; BMI 30-35 with no lung disease; BMI <30 no lung disease; BMI <30 with lung disease; BMI >35 with lung disease; BMI >35 with no lung disease

High Flow Nasal Cannulae DEVICE

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.

BMI 30-35 with lung disease; BMI 30-35 with no lung disease; BMI <30 no lung disease; BMI <30 with lung disease; BMI >35 with lung disease; BMI >35 with no lung disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 3G1, Canada

Location

Related Publications (4)

• 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.

  PMID: 25548602 BACKGROUND

• 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.

  PMID: 21447489 BACKGROUND

• 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.

  PMID: 19399574 BACKGROUND

• 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.

  PMID: 22050948 BACKGROUND

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Interventions will be labeled using a Letter key so the analysis of the dataset by our statistician will be blinded
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Will test preoxygenation using High Flow Nasal Cannulae, Non-rebreather mask and Bag-Valve-Mask

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 7, 2017
• Study Start: July 30, 2018
• Primary Completion: March 15, 2023
• Study Completion: March 15, 2023
• Last Updated: January 5, 2024

Record last verified: 2021-03

Locations

CA (1)