Preoxygenation With High Flow Nasal Cannula Prolongs Normoxia Time During Induction of Anaesthesia of Bariatric Patients and is Superior to Conventional Preoxygenation With Face Mask.

Sponsor

Staedtisches Klinikum Karlsruhe (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04965610

Collaborator

(none)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

To compare preoxygenation for induction of general anaesthesia with High Flow Nasal Cannula vs preoxygenation with face mask in patients undergoing bariatric surgery. The hypothesis is that preoxygenation with High Flow Nasal Cannula prolongs normoxia time during induction of anaeshesia and is superior to conventional preoxygenation with face mask. Primary endpoint will be the time during which spO2 > 92 %. Secondary endpoint will be paCO2.

Condition or Disease	Intervention/Treatment	Phase
Compare Preoxygenation Methods in Bariatric Patients	Other: Preoxygenation with High Flow Nasal Cannula Other: Preoxygenation via face mask	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Two groups of patients. One receiving preoxygenation via High Flow Nasal Cannula and one group receiving preoxygenation via face maskTwo groups of patients. One receiving preoxygenation via High Flow Nasal Cannula and one group receiving preoxygenation via face mask

Masking:

None (Open Label)

Masking Description:

Patients will be divided into two groups by lot.

Primary Purpose:

Prevention

Official Title:

Preoxygenation With High Flow Nasal Cannula Prolongs Normoxia Time During Induction of Anaesthesia of Bariatric Patients and is Superior to Conventional Preoxygenation With Face Mask.

Anticipated Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Preoxygenation via THRIVE/High Flow Nasal Cannula Patients receive preoxygenation for induction of general anaesthesia via High Flow Nasal Cannula for the duration of 5 minutes. After that the induction agents will be given. Now arterial blood gases will be drawn every 2 minutes and the SpO2 will be measured until the 6th apnoeic ABG or if the SpO2 decreases to 92%. After that normal intubation follows.	Other: Preoxygenation with High Flow Nasal Cannula Preoxygenation for 5 minutes via High Flow Nasal Cannula. After induction of anaesthesia apnoeic oxygenation with HFNC
Active Comparator: Preoxygenation via face mask (PROX) Patients receive preoxygenation for induction of general anaesthesia via tight fitting face mask for the duration of 5 minutes. After that the induction agents will be given. Now arterial blood gases will be drawn every 2 minutes and the SpO2 will be measured until the 6th apnoeic ABG or if the SpO2 decreases to 92%. After that normal intubation follows.	Other: Preoxygenation via face mask Preoxygenation for 5 minutes via face mask. After induction of anaesthesia apnoeic oxygenation with tight fitting face mask

Arm

Intervention/Treatment

Experimental: Preoxygenation via THRIVE/High Flow Nasal Cannula

Patients receive preoxygenation for induction of general anaesthesia via High Flow Nasal Cannula for the duration of 5 minutes. After that the induction agents will be given. Now arterial blood gases will be drawn every 2 minutes and the SpO2 will be measured until the 6th apnoeic ABG or if the SpO2 decreases to 92%. After that normal intubation follows.

Other: Preoxygenation with High Flow Nasal Cannula

Preoxygenation for 5 minutes via High Flow Nasal Cannula. After induction of anaesthesia apnoeic oxygenation with HFNC

Active Comparator: Preoxygenation via face mask (PROX)

Patients receive preoxygenation for induction of general anaesthesia via tight fitting face mask for the duration of 5 minutes. After that the induction agents will be given. Now arterial blood gases will be drawn every 2 minutes and the SpO2 will be measured until the 6th apnoeic ABG or if the SpO2 decreases to 92%. After that normal intubation follows.

Other: Preoxygenation via face mask

Preoxygenation for 5 minutes via face mask. After induction of anaesthesia apnoeic oxygenation with tight fitting face mask

Outcome Measures

Primary Outcome Measures

Normoxia time SpO2 > 92% [10 Minutes after induction]
Time in which the SpO2 remains > 92% while patient is apnoeic

Secondary Outcome Measures

paCO2 [10 Minutes after induction]
Increase in arterial CO2 during Apnoea

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

age over 18
elective bariatric surgery
written consent

Exclusion Criteria:

preexisting lung diseases, congenital heart diseases
known difficult airway
SpO2 < 92% under ambient air conditions
known diaphragmal hernia
clinically relevant reflux

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Staedtisches Klinikum Karlsruhe

Investigators

Principal Investigator: Joachim Jugl, Senior Resident Anaesthesia
Study Director: Franz Kehl, Prof., Head of Department of Anaesthesia and Intensive Care

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Joachim Jugl, Assistenzarzt Anästhesie, Staedtisches Klinikum Karlsruhe

ClinicalTrials.gov Identifier:

NCT04965610

Other Study ID Numbers:

070720211

First Posted:

Jul 16, 2021

Last Update Posted:

Jul 16, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 16, 2021