Health TrialsbyHealthPanel

High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill

ConditionsCritical IllnessRespiratory FailureMulti Organ FailureHypoxia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorRegion Stockholm

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult, ≥18 years old

Intensive care patients that require tracheal intubation for any indication

Disqualifiers

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

Trial population

All adult critically ill patients requiring intubation in the intensive care unit at Karolinska University Hospital Solna, Sweden will be included.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Optiflow Switch

    Device

    High flow nasal oxygen with the Optiflow Switch device

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Tight facemask or NIV0 interventions
Group B: High Flow Nasal Oxygen and Tight facemask/ NIV1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
5 minutes post intubation

Secondary outcomes

1

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.

Time frame
5 minutes
2

Change of intubation method

Difference in change of intubation method when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.

Time frame
5 minutes
3

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.

Time frame
30 days
4

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.

Time frame
5 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Region Stockholm

Lead sponsor

Karolinska Institutet

Collaborator

Source ClinicalTrials.gov
Apply now