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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypoxia; Critical Illness; Respiratory Failure; Multi Organ Failure
• Intervention / Treatment: 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 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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Ida-Maria Forsberg, PhD; Phone Number: + 46704381445; Email: ida-maria.forsberg@regionstockholm.se

Study Locations

• Sweden
  • Stockholm, Sweden, 17176
    • Recruiting
    • Karolinska University Hospital
    • Contact: Ida-Maria Forsberg, PhD; Phone Number: +46704381445; Email: ida-maria.forsberg@regionstockholm.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change of intubation method	Difference in change of intubation method when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.	5 minutes
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
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
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
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
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
Number of intubation attempts	Difference in number of intubation attempts when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.	30 minutes
Number of oesophageal intubations	Difference in number of oesophageal intubations when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.	30 minutes
30-day mortality	Difference in 30-day mortality when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.	30 days
Perceived operator stress	Difference in perceived operator stress during intubation when using Optiflow Switch peri-oxygenation compared to traditional preoxygenation.	30 minutes

Collaborators and Investigators

• Sponsor: Region Stockholm
• Collaborators: Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2023
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: May 11, 2023
• First Submitted That Met QC Criteria: May 22, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Critical care; Intensive care; Airway management; Apnoeic oxygenation
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes; Shock; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Critical Illness; Hypoxia; Multiple Organ Failure
• Other Study ID Numbers: 2023-0063201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No