CClinicalTrials.gg
CompletedNCT03458091A-THRIVEUpdated Oct 14, 2020

Evaluation of Lung Atelectasis During Apneic Oxygenation Using THRIVE in Adults During Laryngeal Surgery.

An interventional study of THRIVE and Endotracheal intubation in Anesthesia, sponsored by Karolinska University Hospital. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-14.

Sponsored by Karolinska University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Oxygenation with high-flow nasal cannula with 100% oxygen have now been evaluated in a number of studies and the data are convincing. The THRIVE technique is able to oxygenate patients safely and vital parameters has been shown to be stable. But it is of great importance to evaluate this new concept regarding other potential negative physiological aspects such as lung atelectasis and inflammatory stress response before implementing it into clinical practice.

02

Conditions studied

  • Anesthesia

Browse trials for

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. ASA>2
  2. NYHA >2
  3. Pacemaker or ICD.
  4. BMI >35
  5. Pregnancy
  6. Manifest cardiac failure or coronary disease
  7. Severe gastrointestinal reflux.
  8. Neuromuscular disorder
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    Intubation

    The patients will be intubated and ventilated

    Device: Endotracheal intubation

  • Experimental
    THRIVE

    The patients will be oxygenated during apnea using THRIVE

    Device: THRIVE

Interventions

  • DeviceTHRIVE

    Oxygenation during apnea using transversal humidified oxygen

  • DeviceEndotracheal intubation

    Ventilation during the procedure is governed by an endotracheal tube in the trachea and mechanical ventilation

05

What researchers measure

Primary outcomes

  1. Electrical impedans tomography

    Changes in lung volumes

    Time frame: baseline, intraoperative, 2 hours after start of intervention

Secondary outcomes

  1. Difference in Endtidal and arterial carbon dioxide partial pressure in the end of the procedure

    Difference in Endtidal and arterial carbon dioxide partial pressure in the end of the procedure

    Time frame: max 30 minutes after start of intervention

  2. Increase in arterial carbon dioxide during the apnea

    Measurement of arterial blood gases and here arterial carbon dioxide

    Time frame: max 30 minutes after start of intervention

06

Study locations

1 site
  • Karolinska University Hospital
    Stockholm, Sweden
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03458091
Lead sponsor
Karolinska University Hospital
Responsible party
Malin Jonsson Fagerlund (Senior Consultant, Associate Professor, Karolinska University Hospital) — Principal investigator
First posted
Mar 8, 2018
Start date
Jan 22, 2018
Primary completion
Oct 10, 2020
Completion
Oct 10, 2020
Last update
Oct 14, 2020

Study contacts

Malin Jonsson Fagerlund
principal investigator · Karolinska University Hospital and Karolinska Institutet

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion