Oxygenation by 100% Oxygen Via High Flow Nasal Cannula in Surgical Patients

December 17, 2017 updated by: Malin Jonsson Fagerlund, Karolinska University Hospital

Evaluation of Oxygenation by 100% Oxygen Via High Flow Nasal Cannula During Apnea in Adult Elective Surgical ENT Patients

Oxygenation with high-flow nasal cannula with 100% oxygen has only been evaluated in a limited number of studies. Although data are convincing it is of importance to evaluate this new concept in our department before implementing it into clinical practice.

The general purpose of this project is to evaluate a new ventilation strategy during ENT-surgery based on oxygenation with high-flow nasal cannula with 100% oxygen with focus on gas exchange.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adult, >18 years old
  2. ENT-surgery where apnea is of benefit for the surgeon (eg. intraoral or laryngeal surgery) and the anesthesia time is <40 mins.
  3. Capable of understanding the study information and sign the written consent.

Exclusion Criteria:

  1. ASA>2
  2. NYHA >2
  3. BMI >30
  4. Pregnancy
  5. Manifest cardiac failure or coronary disease
  6. Neuromuscular disease

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Normoventilation
The patients will be normoventilated before anesthesia
EXPERIMENTAL: Hyperventilation
Prior to anesthesia, the patients will hyperventilate during 2 mins or until symptoms from the central nervous system (e.g. dizziness).
Procedure: Hyperventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in arterial carbon dioxide (pCO2)
Time Frame: From start of anaesthesia to end of apnoea oxygenation or max 30 minutes
From start of anaesthesia to end of apnoea oxygenation or max 30 minutes
Change in arterial pH
Time Frame: From start of anaesthesia to end of apnoea oxygenation or max 30 minutes
From start of anaesthesia to end of apnoea oxygenation or max 30 minutes
Change in arterial oxygen tension (pO2)
Time Frame: From start of anaesthesia to end of apnoea oxygenation or max 30 minutes
From start of anaesthesia to end of apnoea oxygenation or max 30 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Does hyperventilation prior to anaesthesia and apnoea oxygenation cause any difference in pCO2 in the end of the apnea (i.e. at up to 30 minutes) compared to normoventilation?
Time Frame: In the end of the apnoea period, i.e. at approximately 20 minutes
In the end of the apnoea period, i.e. at approximately 20 minutes
Does hyperventilation prior to anaesthesia and apnoea oxygenation cause any difference in pH in the end of the apnea (i.e. at up to 30 minutes) compared to normoventilation?
Time Frame: In the end of the apnoea period, i.e. at approximately 20 minutes
In the end of the apnoea period, i.e. at approximately 20 minutes
Does hyperventilation prior to anaesthesia and apnoea oxygenation cause any difference in pO2 in the end of the apnea (i.e. at up to 30 minutes) compared to normoventilation?
Time Frame: In the end of the apnoea period, i.e. at approximately 20 minutes
In the end of the apnoea period, i.e. at approximately 20 minutes
Does the high oxygen content cause atelectasis measures as change in relation between pCO2 and end tidal carbon dioxide
Time Frame: Until discharge from the postoperative unit, often max 2 hours
Until discharge from the postoperative unit, often max 2 hours

Collaborators and Investigators

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

Sponsor

Karolinska University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

December 1, 2015

Primary Completion (ACTUAL)

June 30, 2016

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

December 15, 2015

First Submitted That Met QC Criteria

March 7, 2016

First Posted (ESTIMATE)

March 11, 2016

Study Record Updates

Last Update Posted (ACTUAL)

December 19, 2017

Last Update Submitted That Met QC Criteria

December 17, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • Apnoic Oxygenation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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