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.

July 7, 2021 updated by: Joachim Jugl, Staedtisches Klinikum Karlsruhe
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Franz Kehl, Prof.
  • Phone Number: 00497219741601

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Normoxia time SpO2 > 92%
Time Frame: 10 Minutes after induction
Time in which the SpO2 remains > 92% while patient is apnoeic
10 Minutes after induction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
paCO2
Time Frame: 10 Minutes after induction
Increase in arterial CO2 during Apnoea
10 Minutes after induction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2021

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

July 7, 2021

First Submitted That Met QC Criteria

July 7, 2021

First Posted (Actual)

July 16, 2021

Study Record Updates

Last Update Posted (Actual)

July 16, 2021

Last Update Submitted That Met QC Criteria

July 7, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 070720211

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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