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PreOxygenation In RSI Anesthesia (PRIOR)

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ClinicalTrials.gov Identifier: NCT02794532
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Malin Jonsson Fagerlund, Karolinska University Hospital

Brief Summary:

Pre-oxygenation with high-flow nasal cannula oxygen has been evaluated in a limited number of studies and seems to be better than traditional preoxygenation with a tight fitting mask. Oxygenation with high-flow nasal cannula in apnea demonstrates that this could be done safely for up to 25 mins with preserved saturation. Based on this, the investigators want to evaluate whether this novel concept of preoxygenation can prolong the time to desaturation in emergency anesthesia while securing a possibly difficult airway. This may reduce the number of hypoxic events during intubation. This novel concept has already been tested in clinical practice in certain cases but not during rapid sequence induction for acute surgery.

Objectives and Purpose The general purpose of this project is to compare a new preoxygenation technique based on humidified oxygen in a high-flow nasal cannula with traditional preoxygenation with a tight fitting mask during rapid sequence induction intubation with focus on gas exchange.


Condition or disease Intervention/treatment Phase
Anesthesia Oxygen Procedure: High-flow nasal cannula Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pre-oxygenation With High-flow Nasal Cannula in Comparison to Standard in Adults During Rapid Sequence Induction Anesthesia- a Prospective Randomized Non-blinded Clinical Trial
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : June 1, 2017
Actual Study Completion Date : October 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
No Intervention: Pre oxygenation with 100% oxygen via tight fitting mask
Pre Oxygenation will be done using a tight mask
Experimental: Pre oxygenation with 100% oxygen in high-flow nasal cannula
Pre Oxygenation will be done using high-flow nasal canula
Procedure: High-flow nasal cannula
Oxygenation will be done via a high-flow nasal cannula




Primary Outcome Measures :
  1. Lowest peripheral oxygen saturation from induction of anaesthesia to 1 minute after tracheal intubation [ Time Frame: One minute after tracheal intubation ]
    Peripheral oxygen saturation will be measured. The lowest value from start of anesthesia until up to 1 minute after tracheal intubation is the primary outcome measure.


Secondary Outcome Measures :
  1. Change in level of oxygen saturation during high flow nasal cannula oxygenation compared with traditional pre-oxygenation from time to first anesthetic drug given to 1 minute after intubation. [ Time Frame: One minute after tracheal intubation ]
  2. Number of patients with desaturation below 93 % with high flow nasal cannula oxygenation compared with traditional pre-oxygenation? [ Time Frame: One minute after tracheal intubation ]
  3. Level of end tidal carbon dioxide in the first breath after intubation with high flow nasal cannula oxygenation compared with traditional pre-oxygenation? [ Time Frame: First breath after endotracheal intubation ]
  4. Degree of discomfort with pre oxygenation for the patient [ Time Frame: The assessment will be done at the postoperative unit ]
    The degree of discomfort for the patients will be assessed with a visual analogue scale ranging from 0- 10, where 10 is maximal discomfort



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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. Adult, >18 years old
  2. Emergency intubation where RSI is indicated
  3. Capable of understanding the study information and signing the written consent.
  4. Need for non-invasive ventilation

Exclusion Criteria:

  1. BMI >35
  2. Pregnancy

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): NCT02794532


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, Associate Professor, senior Consultant, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT02794532    
Other Study ID Numbers: PRIOR
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided