Comparison of Three Pre-oxygenation Strategies

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6+
SponsorInstitute of Mountain Emergency Medicine

About this trial

Study objective: Comparing the efficacy of three different preoxygenation strategies, i.e. non-rebreather face mask (NRM), bag-valve-mask (BVM) with and BVM without additional positive end-expiratory pressure (PEEP) in three subgroups of spontaneously breathing volunteers.

Study endpoints

Primary Endpoint:

Difference in expiratory oxygen concentration (FeO2) at the end of the 3 min preoxygenation sessions.

Secondary endpoints:

* Difference in Oxygen Reserve Index (ORi) at the end of the 3 min preoxygenation sessions. * Changes in regional ventilation from baseline to 1.5 min and 3 min into the preoxygenation sessions, assessed using electrical impedance tomography (EIT) * Time to reaching an Oxygen Reserve Index (ORi) ≥ 0.5 * Time to reaching an Oxygen Reserve Index (ORi) =1 * Time to Oxygen Reserve Index (ORi) back to baseline after the 3 min preoxygenation sessions.

Number of participants 15 participants per subgroup, i.e. 45 participants in total.

Inclusion criteria

* Normal-weight adults (body mass index, BMI 18.5-24.9 kg/m2) with an "American Society of Anesthesiologists Physical Status Classification System (ASA) " score of I or II * Adults with a BMI 25-39.9 kg/m2 with and ASA score \<3 * Healthy (ASA I) children aged 6-12 years Exclusion criteria ASA 3, Age \< 6 and age 12-18, pregnant women, missing informed consent, signs and symptoms of an acute respiratory illness on the study day.

After informed consent and a medical check-up, baseline measurements will be done for 10 minutes (peripheral oxygen saturation SpO2, ORI, regional ventilation). Then the participants will undergo 3 different preoxygenation sessions with the 3 interfaces (i.e. non-rebreather facemask with reservoir and a bag-valve-mask with and without PEEP) in a randomized order and a 20 min washout between the sessions. Each preoxygenation session is conducted in a supine position and will be proceeded until the measured FeO2 (end expiratory O2 fraction) reaches 90% or up to a maximum time of 3 min. Afterwards 10 min of SpO2, ORI and regional ventilation measurements will follow.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Normal-weight adults (BMI 18.5-24.9 kg/m2) with an "American Society of Anesthesiologists Physical Status Classification System (ASA) " score of I or II

Adults with a BMI 25-39.9 kg/m2 with and ASA score <3

Healthy (ASA I) children aged 6-12 years

Disqualifiers

ASA 3

Age < 6 and age 12-18

pregnant women

missing informed consent

Trial design

Design model

Crossover

Treatments tested in this trial

  • Preoxygenation

    Other intervention

    Preoxygenation of volunteers over 3 minutes

Treatment groups

45 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: NRM - Non-rebreather mask in children 6-12 yrsActive comparator 1 intervention
Group B: BVM with PEEP in children 6-12 yrsActive comparator 1 intervention
Group C: BVM without PEEP in children 6-12 yrsActive comparator 1 intervention
Group D: NRM - Non-rebreather mask in normal weight adultsActive comparator 1 intervention
Group E: BVM with PEEP in normal weight adultsActive comparator 1 intervention
Group F: BVM without PEEP in normal weight adultsActive comparator 1 intervention
Group G: NRM - Non-rebreather mask in overweight/obese adultsActive comparator 1 intervention
Group H: BVM with PEEP in overweight/obese adultsActive comparator 1 intervention
Group I: BVM without PEEP in overweight/obese adultsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Difference in expiratory oxygen concentration (FeO2) at the end of the 3 min preoxygenation sessions.

Difference in expiratory oxygen concentration (FeO2) at the end of the 3 min preoxygenation sessions between the three arms.

Time frame
After 3 minutes of preoxygenation

Secondary outcomes

1

Difference in Oxygen Reserve Index (ORi) at the end of the 3 min preoxygenation sessions.

Difference in Oxygen Reserve Index (ORi) at the end of the 3 min preoxygenation sessions. ORi ranges from 0.0 to 1.0 and reflects the partial pressure of oxygen in arterial blood (PaO2 80-200).

Time frame
After 3 minutes of preoxygenation
2

Changes in regional ventilation from baseline to 1.5 min and 3 min into the preoxygenation sessions, assessed using electrical impedance tomography (EIT)

Changes in regional ventilation from baseline to 1.5 min and 3 min into the preoxygenation sessions, assessed using electrical impedance tomography (EIT)

Time frame
After 1.5 and 3 minutes of preoxygenation
3

Time to reaching an Oxygen Reserve Index (ORi) ≥ 0.5

Time to reaching an Oxygen Reserve Index (ORi) ≥ 0.5

Time frame
Variable, timepoint during the 3 min preoxygenation session
4

Time to reaching an Oxygen Reserve Index (ORi) =1

Time to reaching an Oxygen Reserve Index (ORi) =1

Time frame
Variable, timepoint during the 3 min preoxygenation session

Other outcomes

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