Critical Illness Clinical Trial
— HiPOXICOfficial title:
High-flow Nasal Oxygenation for Apnoeic Oxygenation With Optiflow Switch During Intubation of the Critically Ill Adult- a Prospective Before-and-after Study
Intubation in the intensive care unit is a standard procedure with a high risk of adverse events such as hypoxaemia and cardiovascular instability. However, it is demonstrated that HFNO (High Flow Nasal Oxygen) for pre and perioxygenation is feasible and, in many situations, prolongs the safe apnoeic period after anaesthesia induction. Previous data of the use of HFNO during intubation of the critically ill is conflicting. With the new device Optiflow Switch, which allow its combination with NIV or tight facemask with perioxygenation, we aim to evaluate whether this could reduce intubation-related hypoxaemia and other adverse events. The general purpose of this project is to compare the addition of Optiflow Switch for pre- and perioxygenation to traditional preoxygenation using a tight-fitting mask or NIV during intubation in adult intensive care patients in a prospective before-and-after study design.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | June 30, 2025 |
Est. primary completion date | May 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - Adult, =18 years old - Intensive care patients that require tracheal intubation for any indication Exclusion Criteria: - Patients with skull or facial injuries where the application of nasal cannula is to be avoided, decided by the intensivist. - Pregnancy - Total nasal obstruction - Deemed not suitable for any other reason than the aforementioned |
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska University Hospital | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Region Stockholm | Karolinska Institutet |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Desaturation up until 5 minutes after intubation | Desaturation (below 90% SpO2 or >5 % if <90% after preoxygenation) up until 5 minutes after intubation in patients receiving standard preoxygenation or with the addition of perioxygenation with HFNO. | 5 minutes post intubation | |
Secondary | Frequency of complications | Difference of frequency of complications (severe arrhythmias or hypotension, cardiac arrest, death) when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation. | 5 minutes | |
Secondary | Change of intubation method | Difference in change of intubation method when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation. | 5 minutes | |
Secondary | Intensive care length of stay | Difference in long-time intensive care outcome (length of stay, 30-day mortality, ventilator-induced pneumonia) when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation. | 30 days | |
Secondary | ETCO2 in the first breath after intubation | Difference in ETCO2 in the first breath after intubation when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation. | 5 minutes | |
Secondary | Duration of intubation | Difference in duration of intubation (from the start of laryngoscopy until ETCO2 is registered) when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation. | 5 minutes | |
Secondary | Arterial oxygen and carbon dioxide levels after intubation | Difference in arterial oxygen and carbon dioxide levels after intubation when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation. | 30 minutes | |
Secondary | Perceived intubation difficulties | Difference in graded (scale 1-5) perceived difficulty during intubation when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation. | 30 minutes | |
Secondary | Number of intubation attempts | Difference in number of intubation attempts when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation. | 30 minutes | |
Secondary | Number of oesophageal intubations | Difference in number of oesophageal intubations when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation. | 30 minutes | |
Secondary | 30-day mortality | Difference in 30-day mortality when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation. | 30 days | |
Secondary | Perceived operator stress | Difference in perceived operator stress during intubation when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation. | 30 minutes |
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