Evaluation of Different Methods for Preoxygenation

NCT05839665 | Completed DMC

• 1 other identifier: PreFlow
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this randomised cross-over study is to compare pre-oxygenation using a standard nasal cannula to pre-oxygenation using humidified high-flow nasal oxygen and a tight-fitting facemask in adult volunteers with a BMI below 30 not suffering from pulmonary or cardiac comorbidity. The main question it aims to answer is: \- Are there any differences in the effectiveness of pre-oxygenation using a standard nasal cannula compared to using a traditional facemask and pre-oxygenation using humidified high-flow nasal oxygen? Participants will be pre-oxygenated with 100% oxygen during four minutes intervals. All participants will be pre-oxygenated with various flow rates using a standard nasal cannula, a facemask and humidified high-flow nasal oxygen. End-tidal oxygen concentrations will be measured continuously in order to evaluate the effectiveness of pre-oxygenation. Each volunteer will be pre-oxygenated repeatedly, with different flow rates, with all three methods of pre-oxygenation and act as its own control. During facemask pre-oxygenation volunteers will be pre-oxygenated using both tidal volume breathing for four minutes and with eight vital capacity breaths. During pre-oxygenation using the standard nasal cannula flow rates will vary between 15 and 50 l/min. Pre-oxygenation using humidified high-flow nasal oxygen will be performed with flow rates varying between 30 and 50 l/min. Series will be conducted with volunteers breathing with both opened and closed mouth as well as with four minutes of tidal volume breathing and eight vital capacity breaths. All volunteers will start with facemask pre-oxygenation. They will thereafter be randomised to pre-oxygenation with either a standard nasal cannula or humidified high-flow nasal oxygen. Lastly, they will be pre-oxygenated with the remaining method according to the randomisation.

Conditions

Anesthesia

Keywords

Preoxygenation; Oxygenation; High-flow nasal oxygen; Low-flow nasal oxygen

Outcome Measures

Primary Outcomes (1)

• Comparison of the effectiveness of pre-oxygenation

  Compare end-tidal oxygen levels after three minutes of pre-oxygenation using a standard facemask, high-flow nasal oxygen and a standard nasal cannula.

  After 3 minutes of preoxygenation

Secondary Outcomes (7)

• Duration of pre-oxygenation until end-tidal oxygen levels above 80%

  After 3 minutes of preoxygenation

• Duration of pre-oxygenation until end-tidal oxygen levels above 85%

  After 3 minutes of preoxygenation

• Continuous comparison of end-tidal oxygen levels

  After 3 minutes of preoxygenation

• Pre-oxygenation with open and closed mouth

  After 3 minutes of preoxygenation

• Vital capacity breathing vs tidal volume breathing

  After 3 minutes of preoxygenation

Other Outcomes (1)

• Safety outcome

  After 3 minutes of preoxygenation

Study Arms (3)

Humidified high-flow oxygen

ACTIVE COMPARATOR

Humidified high-flow nasal oxygen delivered via the Optiflow device. Repeated series with 100% oxygen with flows varying between 30 to 50 l/min. Volunteers will also be pre-oxygenated with both opened and closed mouth.

Device: Humidified high-flow nasal oxygen

Standard nasal cannula

EXPERIMENTAL

Standard nasal cannula connected to an oxygen rotameter Repeated series with 100% oxygen with flows varying between 15 to 50 l/min. Volunteers will also be pre-oxygenated with both opened and closed mouth.

Device: Standard nasal cannula

Facemask

ACTIVE COMPARATOR

Tight-fitting facemask. Two series will be done where pre-oxygenation will be performed with four minutes of tidal volume breathing and eight vital capacity breaths. This arm is not randomised. All study subjects will start with facemask pre-oxygenation and are thereafter randomised to standard nasal cannula or humidified high-flow nasal cannula.

Device: Facemask

Interventions

Humidified high-flow nasal oxygen DEVICE

Humidified high-flow oxygen delivered via the Optiflow device

Humidified high-flow oxygen

Standard nasal cannula DEVICE

Oxygen delivered with high flows via a standard nasal cannula

Standard nasal cannula

Facemask DEVICE

Oxygen delivered with facemask

Facemask

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and sign informed consent
• Age 25-65 years
• Body mass index \<30

You may not qualify if:

• Heart disease
• Respiratory disease
• Pregnancy
• Smoker

Sponsors & Collaborators

• Malin Jonsson Fagerlund: lead
• Karolinska Institutet: collaborator

Study Sites (2)

Perioperative Medicine and Intensive Care Medicine

Stockholm, SE-17176, Sweden

Location

Karolinska University Hospital, Solna

Stockholm, Sweden

Location

Related Publications (1)

• Sjoblom A, Hedberg M, Forsberg IM, Hoffman F, Jonsson Fagerlund M. Comparison of preoxygenation using a tight facemask, humidified high-flow nasal oxygen and a standard nasal cannula - a volunteer, randomised, crossover study. Eur J Anaesthesiol. 2024 Jun 1;41(6):430-437. doi: 10.1097/EJA.0000000000001989. Epub 2024 Apr 16.

  PMID: 38630525 DERIVED

Study Officials

• Malin Jonsson Fagerlund

  Karolinska University Hospital and Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: All volunteers will start with pre-oxygenation using a traditional facemask (vital breathing for four minutes vital and eight vital capacity breaths). They will thereafter be randomised to continue with either pre-oxygenation using a standard nasal cannula or humidified high-flow nasal oxygen.

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 3, 2023
• Study Start: May 2, 2023
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: August 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)