Pre-oxygenation With Facemask Oxygen vs High-flow Nasal Oxygen vs High-flow Nasal Oxygen Plus Mouthpiece Oxygen (PREOX)

February 22, 2021 updated by: John Laffey, University College Hospital Galway

Pre-oxygenation With Facemask Oxygen vs High-flow Nasal Oxygen vs High-flow Nasal Oxygen Plus Mouthpiece Oxygen - a Randomised Controlled Trial

Pre-oxygenation increases oxygen reserves in the body to reduce the likelihood of oxygen desaturation on induction of general anaesthesia. Pre-oxygenation with facemask is the commonest method method of pre-oxygenation. High-flow nasal oxygen is a newer alternative. This study randomises participants to receive pre-oxygenation by one of three methods: facemask, high-flow nasal oxygen, high-flow nasal oxygen plus mouthpiece.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The administration of supplemental oxygen prior to induction of anaesthesia is known as pre-oxygenation. Pre-oxygenation increases oxygen reserves in the body with the purpose of delaying the time until oxygen desaturation after breathing stops (apnoea) following the administration of an anaesthetic. In the last decade, clinicians have begun utilising high-flow nasal oxygen for pre-oxygenation. However, the rationale for this is based largely on its ability to achieve ongoing oxygenation after the onset of apnoea (apnoeic oxygenation). This study isolates oxygen administration with high-flow nasal oxygen to the period when the person is breathing, without ongoing oxygen administration during the apnoea period, to quantify its effects during the pre-oxygenation period only. A third group of participants breathes oxygen through a mouthpiece in addition to receiving oxygen via high-flow nasal cannulae. The effect of these pre-oxygenation methods will be measured by the time taken until oxygen saturation levels decline to the lower end of the normal range (92%), along with other parameters such as blood oxygen levels.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Galway, Ireland
        • University Hospital Galway

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age or older
  • ASA 1 or 2
  • Receiving a general anaesthetic for non-emergent surgery

Exclusion Criteria:

  • ASA score ≥3
  • BMI ≥ 30 kg/m2
  • Nasal obstruction
  • Baseline SpO2 ≤95% on room air
  • Anticipated difficult airway management
  • Requirement for awake intubation
  • Pregnancy
  • Positive PCR test for coronavirus.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Facemask oxygen (FM)
100% oxygen administered via facemask through circle system with adjustable pressure-limiting valve at 0 cmH20. Participant instructed to 'breathe normally'
Other: Pre-oxygenation

Induction of anaesthesia after 2mins 45 seconds of pre-oxygenation with 1-1.5mcg/kg remifentanil plus 2-3mg/kg propofol. Propofol (10mg/kg/hr) and remifentanil (0.15mcg/kg/min) infusions commenced until study conclusion.

Positive pressure ventilation commenced at Sp02 92%. Failure to intubate the patient during the first minute of apnoea results in withdrawal from the study.

Blood samples obtained from an arterial catheter immediately prior to commencing pre-oxygenation, after 90 and 180 seconds of pre-oxygenation, after one minute of apnoea, and every two minutes during the apnoeic period.
ACTIVE_COMPARATOR: High-flow nasal oxygen (HFNO)
100% oxygen administered via high-flow nasal cannulae at 50 L/min. Participant instructed to 'keep the mouth closed and breathe normally'
Other: Pre-oxygenation

Induction of anaesthesia after 2mins 45 seconds of pre-oxygenation with 1-1.5mcg/kg remifentanil plus 2-3mg/kg propofol. Propofol (10mg/kg/hr) and remifentanil (0.15mcg/kg/min) infusions commenced until study conclusion.

Positive pressure ventilation commenced at Sp02 92%. Failure to intubate the patient during the first minute of apnoea results in withdrawal from the study.

Blood samples obtained from an arterial catheter immediately prior to commencing pre-oxygenation, after 90 and 180 seconds of pre-oxygenation, after one minute of apnoea, and every two minutes during the apnoeic period.
ACTIVE_COMPARATOR: High-flow nasal oxygen plus mouthpiece oxygen (HFNO+MP)
100% oxygen administered via high-flow nasal cannulae at 50 L/min. Additionally, 100% oxygen administered via mouthpice through circle system with adjustable pressure-limiting valve at 0 cmH20. Participant instructed to 'keep the mouth closed and breathe normally'.
Other: Pre-oxygenation

Induction of anaesthesia after 2mins 45 seconds of pre-oxygenation with 1-1.5mcg/kg remifentanil plus 2-3mg/kg propofol. Propofol (10mg/kg/hr) and remifentanil (0.15mcg/kg/min) infusions commenced until study conclusion.

Positive pressure ventilation commenced at Sp02 92%. Failure to intubate the patient during the first minute of apnoea results in withdrawal from the study.

Blood samples obtained from an arterial catheter immediately prior to commencing pre-oxygenation, after 90 and 180 seconds of pre-oxygenation, after one minute of apnoea, and every two minutes during the apnoeic period.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to oxygen desaturation
Time Frame: Immediately after the intervention
The time period from the onset of apnoea (determined by visual inspection) until an oxygen saturation of 92% is measured by pulse oximetry.
Immediately after the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Arterial partial pressure of oxygen after pre-oxygenation.
Time Frame: At 3 minutes of pre-oxygenation
As measured by blood gas analysis
At 3 minutes of pre-oxygenation
Arterial partial pressure of carbon dioxide change during pre-oxygenation
Time Frame: At 0 and 3 minutes
As measured by blood gas analysis
At 0 and 3 minutes
Change in arterial partial pressure of carbon dioxide during apnoea
Time Frame: At 0, 1, 2 minutes and each 2 minutes thereafter
As measured by blood gas analysis
At 0, 1, 2 minutes and each 2 minutes thereafter
Change in acid-base status during apnoea
Time Frame: At 0, 1, 2 minutes and each 2 minutes thereafter
As measured by blood gas analysis
At 0, 1, 2 minutes and each 2 minutes thereafter
Correlation between end-tidal carbon dioxide measurement and arterial partial pressure of carbon dioxide
Time Frame: Etco2 obtained at the time of resumption of ventilation. Paco2 obtained from the preceding blood gas measurement.
The EtCO2 value used for comparison is the highest value recorded during the first five respiratory cycles by manual ventilation with the adjustable pressure-limiting valve set at 20cmH20.
Etco2 obtained at the time of resumption of ventilation. Paco2 obtained from the preceding blood gas measurement.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University College Hospital Galway

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 13, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 13, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Preox-HFNO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The sharing of anonymised patient-specific data that underlie results in any publication.

IPD Sharing Time Frame

Post publication of results for up to fifteen years

IPD Sharing Access Criteria

Investigator will consider requests to share patient-specific anonymised data in electronic format for the purpose of meta-analysis

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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