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

Sponsor

Region Stockholm (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05883137

Collaborator

Karolinska Institutet (Other)

200

Enrollment

25.4

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Critical Illness Respiratory Failure Multi Organ Failure Hypoxia	Device: Optiflow Switch

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, 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, all 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Anticipated Study Start Date :

May 20, 2023

Anticipated Primary Completion Date :

May 31, 2025

Anticipated Study Completion Date :

Jun 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Tight facemask or NIV Preoxygenation with tight fitting facemask or NIV (non-invasive ventilation) according to the paitents need before anaesthesia induction.
High Flow Nasal Oxygen and Tight facemask/ NIV Pre and peri-oxygenation with HFNO using Optiflow Switch in addition to tight fitting facemask or NIV (non-invasive ventilation).	Device: Optiflow Switch High flow nasal oxygen with the Optiflow Switch device

Arm

Intervention/Treatment

Tight facemask or NIV

Preoxygenation with tight fitting facemask or NIV (non-invasive ventilation) according to the paitents need before anaesthesia induction.

High Flow Nasal Oxygen and Tight facemask/ NIV

Pre and peri-oxygenation with HFNO using Optiflow Switch in addition to tight fitting facemask or NIV (non-invasive ventilation).

Device: Optiflow Switch

High flow nasal oxygen with the Optiflow Switch device

Outcome Measures

Primary Outcome Measures

Desaturation up until 5 minutes after intubation [5 minutes post 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.

Secondary Outcome Measures

Frequency of complications [5 minutes]
Difference of frequency of complications (severe arrhythmias or hypotension, cardiac arrest, death) when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.
Change of intubation method [5 minutes]
Difference in change of intubation method when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.
Intensive care length of stay [30 days]
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.
ETCO2 in the first breath after intubation [5 minutes]
Difference in ETCO2 in the first breath after intubation when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.
Duration of intubation [5 minutes]
Difference in duration of intubation (from the start of laryngoscopy until ETCO2 is registered) when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.
Arterial oxygen and carbon dioxide levels after intubation [30 minutes]
Difference in arterial oxygen and carbon dioxide levels after intubation when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.
Perceived intubation difficulties [30 minutes]
Difference in graded (scale 1-5) perceived difficulty during intubation when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.
Number of intubation attempts [30 minutes]
Difference in number of intubation attempts when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.
Number of oesophageal intubations [30 minutes]
Difference in number of oesophageal intubations when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.
30-day mortality [30 days]
Difference in 30-day mortality when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.
Perceived operator stress [30 minutes]
Difference in perceived operator stress during intubation when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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