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

Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02706431
• Other study ID #: Apnoic Oxygenation
• Status: Completed
• Phase: N/A
• First received: December 15, 2015
• Last updated: December 17, 2017
• Start date: December 1, 2015
• Est. completion date: September 1, 2016

Study information

• Verified date: December 2017
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 1, 2016
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anaesthesia, General
• Anesthesia, Intravenous
• Ventilation

Intervention

Procedure:
• Hyperventilation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in arterial carbon dioxide (pCO2)		From start of anaesthesia to end of apnoea oxygenation or max 30 minutes
Primary	Change in arterial pH		From start of anaesthesia to end of apnoea oxygenation or max 30 minutes
Primary	Change in arterial oxygen tension (pO2)		From start of anaesthesia to end of apnoea oxygenation or max 30 minutes
Secondary	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?		In the end of the apnoea period, i.e. at approximately 20 minutes
Secondary	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?		In the end of the apnoea period, i.e. at approximately 20 minutes
Secondary	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?		In the end of the apnoea period, i.e. at approximately 20 minutes
Secondary	Does the high oxygen content cause atelectasis measures as change in relation between pCO2 and end tidal carbon dioxide		Until discharge from the postoperative unit, often max 2 hours