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.

NCT04965610 | Unknown

• 1 other identifier: 070720211
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Compare Preoxygenation Methods in Bariatric Patients

Outcome Measures

Primary Outcomes (1)

• Normoxia time SpO2 > 92%

  Time in which the SpO2 remains \> 92% while patient is apnoeic

  10 Minutes after induction

Secondary Outcomes (1)

• paCO2

  10 Minutes after induction

Study Arms (2)

Preoxygenation via THRIVE/High Flow Nasal Cannula

EXPERIMENTAL

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 via face mask (PROX)

ACTIVE COMPARATOR

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

Interventions

Preoxygenation with High Flow Nasal Cannula OTHER

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

Preoxygenation via THRIVE/High Flow Nasal Cannula

Preoxygenation via face mask OTHER

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

Preoxygenation via face mask (PROX)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age over 18
• elective bariatric surgery
• written consent

You may not qualify if:

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

Sponsors & Collaborators

• Staedtisches Klinikum Karlsruhe: lead

Study Officials

• Joachim Jugl

  Senior Resident Anaesthesia

  PRINCIPAL INVESTIGATOR

• Franz Kehl, Prof.

  Head of Department of Anaesthesia and Intensive Care

  STUDY DIRECTOR

Central Study Contacts

Joachim Jugl

CONTACT

004972197467846; Joachim.Jugl@klinikum-karlsruhe.de

Franz Kehl, Prof.

CONTACT

00497219741601

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patients will be divided into two groups by lot.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistenzarzt Anästhesie

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

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 16, 2021
• Study Start: October 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 16, 2021

Record last verified: 2021-07