The Effect of High-flow Nasal Oxygen Flow Rate on Gas Exchange During Apnoea

NCT05124093 | Completed

• 1 other identifier: CA2361
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

Apnoeic oxygenation refers to oxygenation that occurs through the insufflation of oxygen into the lungs in the absence spontaneous respiration or positive pressure ventilation. It is used to extend the time to desaturation at induction of anaesthesia and as a primary oxygenation technique during airway surgery. The impact of high-flow nasal oxygen flow rate selection on gas exchange is poorly understood. Participants in this study will be randomised to receive a certain nasal oxygen flow rate during apnoea and its effect on gas exchange will be measured by blood gas analysis.

Conditions

Apnea; Respiration; Arrest; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Rise in arterial partial pressure of carbon dioxide

  The rate of rise of the partial pressure of carbon dioxide between 60 seconds and 240 seconds of apnoea as measured by arterial blood gas analysis.

  Between 1 and 4 minutes of apnoea

Secondary Outcomes (5)

• Partial pressure of oxygen during apnoea

  Following high-flow nasal oxygen administration

• Time to oxygen desaturation

  Immediately after the intervention

• Change in carbon dioxide elevation before and after HFNO administration

  Between 3 and 5 minutes of apnoea

• Carbon dioxide elevation during the first minute of apnoea

  Between 0 and 1 minute of apnoea

• Change in acid-base status during apnoea

  At 1 minute intervals during apnoea

Study Arms (3)

Apnoea without apnoeic oxygenation

PLACEBO COMPARATOR

High-flow nasal oxygen administration ceases at the onset of apnoea.

Procedure: Apnoeic oxygenation

Apnoeic oxygenation with high-flow nasal oxygen at 70 L/min (HFNO)

ACTIVE COMPARATOR

100% oxygen is administered via high-flow nasal cannulae at 70L/min from the onset of apnoea until four minutes of apnoea has completed.

Procedure: Apnoeic oxygenation

Apnoeic oxygenation with high-flow nasal oxygen at 120 L/min (uHFNO)

ACTIVE COMPARATOR

100% oxygen is administered via high-flow nasal cannulae at 120L/min from the onset of apnoea until four minutes of apnoea has completed.

Procedure: Apnoeic oxygenation

Interventions

Apnoeic oxygenation PROCEDURE

After 2mins 45 seconds of pre-oxygenation with high-flow nasal oxygen at Fio2 1.0 at 50L/min, anaesthesia is induced with 1-1.5mcg/kg remifentanil plus 2-3mg/kg propofol. Propofol (10mg/kg/hr) and remifentanil (0.15mcg/kg/min) infusions administered until study conclusion. At the onset of apnoea, 1mg/kg rocuronium administered. Jaw thrust performed. High-flow nasal oxygen adjusted to the randomised flow rate. Videolaryngoscopy after 1 minute of apnoea. Airway patency maintained. Tracheal intubation after 4 minutes of apnoea. Positive pressure ventilation commenced at Spo2 92%. Failure to obtain view of glottis with videolaryngoscope 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 each minute of apnoea until six minutes of apnoea, and every two minutes of apnoea thereafter, until Spo2 92%.

Apnoea without apnoeic oxygenation; Apnoeic oxygenation with high-flow nasal oxygen at 120 L/min (uHFNO); Apnoeic oxygenation with high-flow nasal oxygen at 70 L/min (HFNO)

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 in preceding 14 days.

Sponsors & Collaborators

• University College Hospital Galway: lead

Study Sites (1)

University Hospital Galway

Galway, Ireland

Location

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: November 5, 2021
• First Posted: November 17, 2021
• Study Start: November 22, 2021
• Primary Completion: May 25, 2022
• Study Completion: May 25, 2022
• Last Updated: July 11, 2022

Record last verified: 2022-07

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)