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

Primary Purpose

Anesthesia

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
THRIVE
Endotracheal intubation
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Intubation

THRIVE

Arm Description

The patients will be intubated and ventilated

The patients will be oxygenated during apnea using THRIVE

Outcomes

Primary Outcome Measures

Electrical impedans tomography
Changes in lung volumes

Secondary Outcome Measures

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
Increase in arterial carbon dioxide during the apnea
Measurement of arterial blood gases and here arterial carbon dioxide

Full Information

First Posted
January 21, 2018
Last Updated
October 13, 2020
Sponsor
Karolinska University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03458091
Brief Title
Evaluation of Lung Atelectasis During Apneic Oxygenation Using THRIVE in Adults During Laryngeal Surgery.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 22, 2018 (Actual)
Primary Completion Date
October 10, 2020 (Actual)
Study Completion Date
October 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intubation
Arm Type
Active Comparator
Arm Description
The patients will be intubated and ventilated
Arm Title
THRIVE
Arm Type
Experimental
Arm Description
The patients will be oxygenated during apnea using THRIVE
Intervention Type
Device
Intervention Name(s)
THRIVE
Intervention Description
Oxygenation during apnea using transversal humidified oxygen
Intervention Type
Device
Intervention Name(s)
Endotracheal intubation
Intervention Description
Ventilation during the procedure is governed by an endotracheal tube in the trachea and mechanical ventilation
Primary Outcome Measure Information:
Title
Electrical impedans tomography
Description
Changes in lung volumes
Time Frame
baseline, intraoperative, 2 hours after start of intervention
Secondary Outcome Measure Information:
Title
Difference in Endtidal and arterial carbon dioxide partial pressure in the end of the procedure
Description
Difference in Endtidal and arterial carbon dioxide partial pressure in the end of the procedure
Time Frame
max 30 minutes after start of intervention
Title
Increase in arterial carbon dioxide during the apnea
Description
Measurement of arterial blood gases and here arterial carbon dioxide
Time Frame
max 30 minutes after start of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults, >18 years old. ENT-surgery where apnea is of benefit for the surgeon (eg. intraoral or laryngeal surgery). Capable of understanding the study information and sign the written consent. Exclusion Criteria: ASA>2 NYHA >2 Pacemaker or ICD. BMI >35 Pregnancy Manifest cardiac failure or coronary disease Severe gastrointestinal reflux. Neuromuscular disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malin Jonsson Fagerlund
Organizational Affiliation
Karolinska University Hospital and Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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