NCT05839665

Evaluation of Different Methods for Preoxygenation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Malin Jonsson Fagerlund · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

Pre-oxygenation before anaesthesia induction is mostly performed using a tight-fitting facemask. Recently, studies have shown that pre-oxygenation using humidified high-flow nasal oxygen is equally effective as pre-oxygenation using a standard tight-fitting facemask. Pre-oxygenation using humidified high-flow nasal oxygen has several potential advantages including improved patient comfort and the possibility of a seamless transition from pre-oxygenation to apnoeic oxygenation. Unfortunately, this technique requires an additional machine which can be expensive and also difficult to use in settings outside a hospital. In this study, pre-oxygenation using a standard nasal cannula delivering a high flow of oxygen will be compared with standard facemask pre-oxygenation and pre-oxygenation using humidified high-flow nasal oxygen 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

Interventions

Type	Name	Description
DEVICE	Humidified high-flow nasal oxygen	Humidified high-flow oxygen delivered via the Optiflow device
DEVICE	Standard nasal cannula	Oxygen delivered with high flows via a standard nasal cannula
DEVICE	Facemask	Oxygen delivered with facemask

Timeline

• Start date: 2023-05-02
• Primary completion: 2023-05-31
• Completion: 2023-05-31
• First posted: 2023-05-03
• Last updated: 2023-08-08

Locations

2 sites across 1 country: Sweden