PreOxygenation In RSI Anesthesia

NCT02794532 | Completed

• 1 other identifier: PRIOR
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anesthesia; Oxygen

Outcome Measures

Primary Outcomes (1)

• Lowest peripheral oxygen saturation from induction of anaesthesia to 1 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.

  One minute after tracheal intubation

Secondary Outcomes (4)

• 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.

  One minute after tracheal intubation

• Number of patients with desaturation below 93 % with high flow nasal cannula oxygenation compared with traditional pre-oxygenation?

  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?

  First breath after endotracheal intubation

• Degree of discomfort with pre oxygenation for the patient

  The assessment will be done at the postoperative unit

Study Arms (2)

Pre oxygenation with 100% oxygen via tight fitting mask

NO INTERVENTION

Pre Oxygenation will be done using a tight mask

Pre oxygenation with 100% oxygen in high-flow nasal cannula

EXPERIMENTAL

Pre Oxygenation will be done using high-flow nasal canula

Procedure: High-flow nasal cannula

Interventions

High-flow nasal cannula PROCEDURE

Oxygenation will be done via a high-flow nasal cannula

Pre oxygenation with 100% oxygen in high-flow nasal cannula

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• BMI \>35
• Pregnancy

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Officials

• Malin Jonsson Fagerlund

  Karolinska University Hospital and Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, senior Consultant

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: June 9, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: October 1, 2017
• Last Updated: December 19, 2017

Record last verified: 2017-12