Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06370689
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-04-11
Brief Title:
Comparison of Three Pre-oxygenation Strategies
Sponsor:
Institute of Mountain Emergency Medicine
Organization:
Institute of Mountain Emergency Medicine
Study Overview
Official Title:
Comparison of Three Pre-oxygenation Strategies for Prehospital Anaesthesia Induction in Children Normal Weight Adults and Obese Adults
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study objective Comparing the efficacy of three different preoxygenation strategies ie 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 15 min and 3 min into the preoxygenation sessions assessed using electrical impedance tomography EIT
Time to reaching an Oxygen Reserve Index ORi 05
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 ie 45 participants in total
Inclusion criteria
Normal-weight adults body mass index BMI 185-249 kgm2 with an American Society of Anesthesiologists Physical Status Classification System ASA score of I or II
Adults with a BMI 25-399 kgm2 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 ie 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
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 15 min and 3 min into the preoxygenation sessions assessed using electrical impedance tomography EIT
Time to reaching an Oxygen Reserve Index ORi 05
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 ie 45 participants in total
Inclusion criteria
Normal-weight adults body mass index BMI 185-249 kgm2 with an American Society of Anesthesiologists Physical Status Classification System ASA score of I or II
Adults with a BMI 25-399 kgm2 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 ie 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None