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

Critical Illness Clinical Trial

— HiPOXIC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05883137
• Other study ID #: 2023-0063201
• Status: Recruiting
• Start date: September 25, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2023
• Source: Region Stockholm
• Contact: Ida-Maria Forsberg, PhD
• Phone: + 46704381445
• Email: ida-maria.forsberg[@]regionstockholm.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Critical Illness
• Hypoxia
• Multi Organ Failure
• Multiple Organ Failure
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Optiflow Switch
High flow nasal oxygen with the Optiflow Switch device

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Region Stockholm	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

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