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

Anesthesia Clinical Trial

— A-THRIVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03458091
• Other study ID #: A-THRIVE
• Status: Completed
• Phase: N/A
• Start date: January 22, 2018
• Est. completion date: October 10, 2020

Study information

• Verified date: October 2020
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 10, 2020
• Est. primary completion date: October 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

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

Related Conditions & MeSH terms

• Anesthesia
• Pulmonary Atelectasis

Intervention

Device:
• THRIVE
Oxygenation during apnea using transversal humidified oxygen
• Endotracheal intubation
Ventilation during the procedure is governed by an endotracheal tube in the trachea and mechanical ventilation

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electrical impedans tomography	Changes in lung volumes	baseline, intraoperative, 2 hours after start of intervention
Secondary	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	max 30 minutes after start of intervention
Secondary	Increase in arterial carbon dioxide during the apnea	Measurement of arterial blood gases and here arterial carbon dioxide	max 30 minutes after start of intervention