Clinical trial NCT02706431: Oxygenation by 100% Oxygen Via High Flow Nasal Cannula in Surgical Patients
Official title: Evaluation of Oxygenation by 100% Oxygen Via High Flow Nasal Cannula During Apnea in Adult Elective Surgical ENT Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anaesthesia, General
Anesthesia, Intravenous
Ventilation
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2016-03-11
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in arterial carbon dioxide (pCO2)
timeFrame: From start of anaesthesia to end of apnoea oxygenation or max 30 minutes
measure: Change in arterial pH
timeFrame: From start of anaesthesia to end of apnoea oxygenation or max 30 minutes
measure: Change in arterial oxygen tension (pO2)
timeFrame: From start of anaesthesia to end of apnoea oxygenation or max 30 minutes
Secondary outcomes:
measure: 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?
timeFrame: In the end of the apnoea period, i.e. at approximately 20 minutes
measure: 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?
timeFrame: In the end of the apnoea period, i.e. at approximately 20 minutes
measure: 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?
timeFrame: In the end of the apnoea period, i.e. at approximately 20 minutes
measure: Does the high oxygen content cause atelectasis measures as change in relation between pCO2 and end tidal carbon dioxide
timeFrame: Until discharge from the postoperative unit, often max 2 hours
Other outcomes:
Locations:
Study officials:
affiliation: Karolinska University Hospital and Karolinska Institutet
name: Malin Jonsson Fagerlund, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gustafsson IM, Lodenius A, Tunelli J, Ullman J, Jonsson Fagerlund M. Apnoeic oxygenation in adults under general anaesthesia using Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) - a physiological study. Br J Anaesth. 2017 Apr 1;118(4):610-617. doi: 10.1093/bja/aex036.