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

High-flow Nasal Oxygenation for Apnoeic Oxygenation With Optiflow Switch During Intubation of the Critically Ill Adult- a Prospective Before-and-after Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05883137
Acronym
HiPOXIC
Enrollment
150
Registered
2023-05-31
Start date
2023-09-25
Completion date
2026-06-30
Last updated
2025-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Hypoxia, Multi Organ Failure, Respiratory Failure

Keywords

Apnoeic oxygenation, Airway management, Intensive care, Critical care

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.

Interventions

DEVICEOptiflow Switch

High flow nasal oxygen with the Optiflow Switch device

Sponsors

Karolinska Institutet
CollaboratorOTHER
Region Stockholm
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Desaturation up until 5 minutes after intubation5 minutes post intubationDesaturation (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

MeasureTime frameDescription
Number of oesophageal intubations30 minutesDifference in number of oesophageal intubations when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.
Frequency of complications5 minutesDifference of frequency of complications (severe arrhythmias or hypotension, cardiac arrest, death) when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.
Change of intubation method5 minutesDifference in change of intubation method when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.
Intensive care length of stay30 daysDifference 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 intubation5 minutesDifference in ETCO2 in the first breath after intubation when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.
Number of intubation attempts30 minutesDifference in number of intubation attempts when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.
Arterial oxygen and carbon dioxide levels after intubation30 minutesDifference in arterial oxygen and carbon dioxide levels after intubation when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.
Perceived intubation difficulties30 minutesDifference in graded (scale 1-5) perceived difficulty during intubation when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.
30-day mortality30 daysDifference in 30-day mortality when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.
Perceived operator stress30 minutesDifference in perceived operator stress during intubation when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.
Duration of intubation5 minutesDifference in duration of intubation (from the start of laryngoscopy until ETCO2 is registered) when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.

Countries

Sweden

Contacts

Primary ContactIda-Maria Forsberg, PhD
ida-maria.forsberg@regionstockholm.se+ 46704381445

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026