Clinical trial NCT05883137: High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
Official title: High-flow Nasal Oxygenation for Apnoeic Oxygenation With Optiflow Switch During Intubation of the Critically Ill Adult- a Prospective Before-and-after Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Critical Illness
Respiratory Failure
Multi Organ Failure
Hypoxia
Keywords: Apnoeic oxygenation
Airway management
Intensive care
Critical care
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
Collaborators: name: Karolinska Institutet
First posted: 2023-05-31
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult critically ill patients requiring intubation in the intensive care unit at Karolinska University Hospital Solna, Sweden will be included.

Brief summary: 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.

Detailed description: This study aims to investigate whether apnoeic oxygenation with Optiflow Switch during tracheal intubation of the critically ill may prevent severe hypoxaemic events. Critically ill patients requiring intubation in the intensive care unit will be preoxygenated with tight facemask/NIV and Optiflow Switch or only tight facemask/ NIV.

During a period of 6-12 months with an aim to include a minimum of 50 patients, patients will be preoxygenated according to routine practice, 100% oxygen via a tight-fitting mask or NIV. During the following 6-12 months, we will change the clinical routine to adding HFNO with Optiflow Switch. During this time, patients, without contraindications will be pre and perioxygenated with HFNO, Optiflow Switch 40-70 L/min, 100 % O2, in combination with a tight facemask or NIV.

Before preoxygenation, the need for and methods for oxygen delivery is noted. Baseline patient characteristics (age, BMI, comorbidities, smoking history, airway related data) and the reason for intensive care admission and intubation will be registered. Scores for physiological compromise and length of intensive care prior to intubation will be noted.

In both groups, the duration of preoxygenation and drugs for anaesthesia induction are chosen by the intensive care physician responsible. Blood gas analysis for arterial oxygen and carbon dioxide partial pressure will be analysed before and after intubation. Before, during and after intubation, vital parameters will be registered.

Intubation-related data and immediate complications such as arterial hypotension, severe cardiac arrhythmia, cardiac arrest, death, oesophageal intubation, regurgitation, or a need for a surgical airway will be noted. Later complications such as ventilator-associated pneumonia and mortality at day 28 as well as duration of mechanical ventilation, length of stay in ICU will be registered.

Patients with contraindications against HFNO and if the responsible anaesthetist is not comfortable using HFNO will be preoxygenated with a traditional facemask or NIV and included in the study group of traditional preoxygenation.

Data will also be collected from the intensive care patient chart regarding all intubations during the study period in order to find patients not included in the study.

Eligibility criteria: 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

Primary outcomes:
measure: Desaturation up until 5 minutes after intubation
timeFrame: 5 minutes post intubation
Secondary outcomes:
measure: Frequency of complications
timeFrame: 5 minutes
measure: Change of intubation method
timeFrame: 5 minutes
measure: Intensive care length of stay
timeFrame: 30 days
measure: ETCO2 in the first breath after intubation
timeFrame: 5 minutes
measure: Duration of intubation
timeFrame: 5 minutes
measure: Arterial oxygen and carbon dioxide levels after intubation
timeFrame: 30 minutes
measure: Perceived intubation difficulties
timeFrame: 30 minutes
measure: Number of intubation attempts
timeFrame: 30 minutes
measure: Number of oesophageal intubations
timeFrame: 30 minutes
measure: 30-day mortality
timeFrame: 30 days
measure: Perceived operator stress
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
References: