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

NCT04767867 | Completed

• 1 other identifier: Preox-HFNO
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Apnea; Respiration; Arrest; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Time to oxygen desaturation

  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 Outcomes (5)

• Arterial partial pressure of oxygen after pre-oxygenation.

  At 3 minutes of pre-oxygenation

• Arterial partial pressure of carbon dioxide change during pre-oxygenation

  At 0 and 3 minutes

• Change in arterial partial pressure of carbon dioxide during apnoea

  At 0, 1, 2 minutes and each 2 minutes thereafter

• Change in acid-base status during apnoea

  At 0, 1, 2 minutes and each 2 minutes thereafter

• Correlation between end-tidal carbon dioxide measurement and arterial partial pressure of carbon dioxide

  Etco2 obtained at the time of resumption of ventilation. Paco2 obtained from the preceding blood gas measurement.

Study Arms (3)

Facemask oxygen (FM)

EXPERIMENTAL

100% oxygen administered via facemask through circle system with adjustable pressure-limiting valve at 0 cmH20. Participant instructed to 'breathe normally'

Other: Pre-oxygenation

High-flow nasal oxygen (HFNO)

ACTIVE COMPARATOR

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

High-flow nasal oxygen plus mouthpiece oxygen (HFNO+MP)

ACTIVE COMPARATOR

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

Interventions

Pre-oxygenation OTHER

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.

Facemask oxygen (FM); High-flow nasal oxygen (HFNO); High-flow nasal oxygen plus mouthpiece oxygen (HFNO+MP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College Hospital Galway: lead

Study Sites (1)

University Hospital Galway

Galway, Ireland

Location

Related Publications (1)

• Lyons C, McElwain J, Coughlan MG, O'Gorman DA, Harte BH, Kinirons B, Laffey JG, Callaghan M. Pre-oxygenation with facemask oxygen vs high-flow nasal oxygen vs high-flow nasal oxygen plus mouthpiece: a randomised controlled trial. Anaesthesia. 2022 Jan;77(1):40-45. doi: 10.1111/anae.15556. Epub 2021 Aug 17.

  PMID: 34402044 DERIVED

MeSH Terms

Conditions

Apnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Callaghan, MB BCh BAO

  Consultant Anaesthesiologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: +Michael Callaghan - principal investigator

Study Record Dates

• First Submitted: January 31, 2021
• First Posted: February 23, 2021
• Study Start: August 1, 2020
• Primary Completion: January 13, 2021
• Study Completion: January 13, 2021
• Last Updated: February 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Post publication of results for up to fifteen years
• Access Criteria: Investigator will consider requests to share patient-specific anonymised data in electronic format for the purpose of meta-analysis

Locations

IE (1)