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.

NCT ID: NCT04965610

Last Updated: 2021-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-31

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Compare Preoxygenation Methods in Bariatric Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

PREVENTION

Blinding Strategy

NONE

Patients will be divided into two groups by lot.

Study Groups

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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.

Group Type EXPERIMENTAL

Preoxygenation with High Flow Nasal Cannula

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Preoxygenation via face mask

Intervention Type OTHER

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

Interventions

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Preoxygenation with High Flow Nasal Cannula

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

Intervention Type OTHER

Preoxygenation via face mask

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Staedtisches Klinikum Karlsruhe

OTHER

Sponsor Role lead

Responsible Party

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Joachim Jugl

Assistenzarzt Anästhesie

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joachim Jugl

Role: PRINCIPAL_INVESTIGATOR

Senior Resident Anaesthesia

Franz Kehl, Prof.

Role: STUDY_DIRECTOR

Head of Department of Anaesthesia and Intensive Care

Central Contacts

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Joachim Jugl

Role: CONTACT

004972197467846

Franz Kehl, Prof.

Role: CONTACT

00497219741601

Other Identifiers

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070720211

Identifier Type: -

Identifier Source: org_study_id

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