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Trial record 79 of 570 for:    CARBON DIOXIDE AND anesthesia

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

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ClinicalTrials.gov Identifier: NCT03458091
Recruitment Status : Enrolling by invitation
First Posted : March 8, 2018
Last Update Posted : April 15, 2019
Sponsor:
Information provided by (Responsible Party):
Malin Jonsson Fagerlund, 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.

Condition or disease Intervention/treatment Phase
Anesthesia Device: THRIVE Device: Endotracheal intubation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Lung Atelectasis During Apneic Oxygenation Using Trans Nasal Humidified Rapid Insufflation Ventilatory Exchange (THRIVE) in Adults During Laryngeal Surgery.
Actual Study Start Date : January 22, 2018
Actual Primary Completion Date : December 31, 2018
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Collapsed Lung

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




Primary Outcome Measures :
  1. Electrical impedans tomography [ Time Frame: baseline, intraoperative, 2 hours after start of intervention ]
    Changes in lung volumes


Secondary Outcome Measures :
  1. Difference in Endtidal and arterial carbon dioxide partial pressure in the end of the procedure [ Time Frame: max 30 minutes after start of intervention ]
    Difference in Endtidal and arterial carbon dioxide partial pressure in the end of the procedure

  2. Increase in arterial carbon dioxide during the apnea [ Time Frame: max 30 minutes after start of intervention ]
    Measurement of arterial blood gases and here arterial carbon dioxide



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03458091


Locations
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Sweden
Karolinska University Hospital
Stockholm, Sweden
Sponsors and Collaborators
Karolinska University Hospital
Investigators
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Principal Investigator: Malin Jonsson Fagerlund Karolinska University Hospital and Karolinska Institutet

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Responsible Party: Malin Jonsson Fagerlund, Senior Consultant, Associate Professor, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT03458091     History of Changes
Other Study ID Numbers: A-THRIVE
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: April 15, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Atelectasis
Lung Diseases
Respiratory Tract Diseases
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action