NCT05839665

Evaluation of Different Methods for Preoxygenation

Completed NA Last updated 8 August 2023

What this trial tests

NA trial testing Humidified high-flow nasal oxygen in Anesthesia in 20 participants. Completed in 31 May 2023.

Timeline

2 May 2023

Primary endpoint
31 May 2023

31 May 2023

Quick facts

Lead sponsor	Malin Jonsson Fagerlund
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	2 May 2023
Primary completion	31 May 2023
Estimated completion	31 May 2023
Sites	2 locations across Sweden

Drugs / interventions tested

• Humidified high-flow nasal oxygen
• Standard nasal cannula
• Facemask

Conditions studied

• Anesthesia — all drugs for Anesthesia →

Sponsor

Malin Jonsson Fagerlund

Who can join

Adults 25 to 65, any sex, with Anesthesia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparison of preoxygenation using a tight facemask, humidified high-flow nasal oxygen and a standard nasal cannula - a volunteer, randomised, crossover study.
   Sjöblom A, Hedberg M, Forsberg IM, Hoffman F, et al · · 2024 · cited 9× · PMID 38630525 · DOI 10.1097/eja.0000000000001989