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Completed

NCT Number: NCT02706431

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

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Key information

Conditions

Anaesthesia, General Anesthesia, Intravenous Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Ventilation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • ASA>2
  • NYHA >2
  • BMI >30
  • Pregnancy
  • Manifest cardiac failure or coronary disease
  • Neuromuscular disease

Treatment and study plan

Hyperventilation

Procedure

Primary outcomes

  1. Change in arterial carbon dioxide (pCO2)

    Time frame: From start of anaesthesia to end of apnoea oxygenation or max 30 minutes

  2. Change in arterial pH

    Time frame: From start of anaesthesia to end of apnoea oxygenation or max 30 minutes

  3. Change in arterial oxygen tension (pO2)

    Time frame: From start of anaesthesia to end of apnoea oxygenation or max 30 minutes

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 11, 2016
Registry last updated
Dec 19, 2017

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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