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Completed

NCT Number: NCT03458091

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

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.

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Key information

Conditions

Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University Hospital

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • ASA>2
  • NYHA >2
  • Pacemaker or ICD.
  • BMI >35
  • Pregnancy
  • Manifest cardiac failure or coronary disease
  • Severe gastrointestinal reflux.
  • Neuromuscular disorder

Treatment and study plan

THRIVE

Device

Oxygenation during apnea using transversal humidified oxygen

Endotracheal intubation

Device

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

Primary outcomes

  1. Electrical impedans tomography

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

    Changes in lung volumes

Secondary outcomes

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

    Time frame: max 30 minutes after start of intervention

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

  2. Increase in arterial carbon dioxide during the apnea

    Time frame: max 30 minutes after start of intervention

    Measurement of arterial blood gases and here arterial carbon dioxide

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Official study title

Evaluation of Lung Atelectasis During Apneic Oxygenation Using Trans Nasal Humidified Rapid Insufflation Ventilatory Exchange (THRIVE) in Adults During Laryngeal Surgery.

Acronym: A-THRIVE

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 8, 2018
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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