Evaluation of Different Methods for Preoxygenation

NCT ID: NCT05839665

Last Updated: 2023-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-02
• Study Completion Date: 2023-05-31

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.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Humidified high-flow oxygen

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.

Group Type: ACTIVE_COMPARATOR

Humidified high-flow nasal oxygen

Intervention Type: DEVICE

Humidified high-flow oxygen delivered via the Optiflow device

Standard nasal cannula

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.

Group Type: EXPERIMENTAL

Standard nasal cannula

Intervention Type: DEVICE

Oxygen delivered with high flows via a standard nasal cannula

Facemask

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.

Group Type: ACTIVE_COMPARATOR

Facemask

Intervention Type: DEVICE

Oxygen delivered with facemask

Interventions

Humidified high-flow nasal oxygen

Humidified high-flow oxygen delivered via the Optiflow device

Intervention Type: DEVICE

Standard nasal cannula

Oxygen delivered with high flows via a standard nasal cannula

Intervention Type: DEVICE

Facemask

Oxygen delivered with facemask

Intervention Type: DEVICE

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Malin Jonsson Fagerlund

OTHER

Sponsor Role: lead

Responsible Party

Malin Jonsson Fagerlund

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Malin Jonsson Fagerlund

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital and Karolinska Institutet

Locations

Perioperative Medicine and Intensive Care Medicine

Stockholm, , Sweden

Karolinska University Hospital, Solna

Stockholm, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 38630525 (View on PubMed)

Other Identifiers

PreFlow

Identifier Type: -

Identifier Source: org_study_id