Clinical trial NCT05839665: Evaluation of Different Methods for Preoxygenation
Official title: Evaluation of Different Methods for Preoxygenation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Keywords: Preoxygenation
Oxygenation
High-flow nasal oxygen
Low-flow nasal oxygen
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2023-05-03
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Heart disease
* Respiratory disease
* Pregnancy
* Smoker

Primary outcomes:
measure: Comparison of the effectiveness of pre-oxygenation
timeFrame: After 3 minutes of preoxygenation
Secondary outcomes:
measure: Duration of pre-oxygenation until end-tidal oxygen levels above 80%
timeFrame: After 3 minutes of preoxygenation
measure: Duration of pre-oxygenation until end-tidal oxygen levels above 85%
timeFrame: After 3 minutes of preoxygenation
measure: Continuous comparison of end-tidal oxygen levels
timeFrame: After 3 minutes of preoxygenation
measure: Pre-oxygenation with open and closed mouth
timeFrame: After 3 minutes of preoxygenation
measure: Vital capacity breathing vs tidal volume breathing
timeFrame: After 3 minutes of preoxygenation
measure: Differences in end-tidal oxygen levels after pre-oxygenation due to age, body mass index or sex.
timeFrame: After 3 minutes of preoxygenation
measure: Discomfort
timeFrame: After 3 minutes of preoxygenation
Other outcomes:
measure: Safety outcome
timeFrame: After 3 minutes of preoxygenation
Locations:
city: Stockholm
country: Sweden
facility: Perioperative Medicine and Intensive Care Medicine
city: Stockholm
country: Sweden
facility: Karolinska University Hospital, Solna
Study officials:
affiliation: Karolinska University Hospital and Karolinska Institutet
name: Malin Jonsson Fagerlund
role: PRINCIPAL_INVESTIGATOR
References: