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

Not Applicable

Completed

• Conditions: Anesthesia
• Interventions: Device: Endotracheal intubation; Device: THRIVE

• Registration Number: NCT03458091
• Lead Sponsor: Karolinska University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-21
• Study Start: 2018-01-22
• Study First Submitted QC: 2018-03-07
• Study First Posted: 2018-03-08
• Status Verified: 2020-10
• Primary Completion: 2020-10-10
• Study Completion: 2020-10-10
• Last Update Submitted: 2020-10-13
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intubation	Endotracheal intubation	The patients will be intubated and ventilated
THRIVE	THRIVE	The patients will be oxygenated during apnea using THRIVE

Primary Outcome Measures

Name	Time	Method
Electrical impedans tomography	baseline, intraoperative, 2 hours after start of intervention	Changes in lung volumes

Secondary Outcome Measures

Name	Time	Method
Difference in Endtidal and arterial carbon dioxide partial pressure in the end of the procedure	max 30 minutes after start of intervention	Difference in Endtidal and arterial carbon dioxide partial pressure in the end of the procedure
Increase in arterial carbon dioxide during the apnea	max 30 minutes after start of intervention	Measurement of arterial blood gases and here arterial carbon dioxide

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden