Evaluation of Lung Atelectasis During Apneic Oxygenation Using THRIVE in Adults During Laryngeal Surgery. (A-THRIVE)

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Device: Endotracheal intubation; Device: THRIVE

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intubation; The patients will be intubated and ventilated	Device: Endotracheal intubation; Ventilation during the procedure is governed by an endotracheal tube in the trachea and mechanical ventilation
Experimental: THRIVE; The patients will be oxygenated during apnea using THRIVE	Device: THRIVE; Oxygenation during apnea using transversal humidified oxygen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electrical impedans tomography	Changes in lung volumes	baseline, intraoperative, 2 hours after start of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Karolinska University Hospital
• Investigators: Principal Investigator: Malin Jonsson Fagerlund, Karolinska University Hospital and Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2018
• Primary Completion (Actual): October 10, 2020
• Study Completion (Actual): October 10, 2020

Study Registration Dates

• First Submitted: January 21, 2018
• First Submitted That Met QC Criteria: March 7, 2018
• First Posted (Actual): March 8, 2018

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 13, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: A-THRIVE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No