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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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 ]
- 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 ]
- 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 ]
- 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
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
|Principal Investigator:||Malin Jonsson Fagerlund||Karolinska University Hospital and Karolinska Institutet|