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

NCT05883137 | Recruiting

• 1 other identifier: 2023-0063201
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Respiratory Failure; Multi Organ Failure; Hypoxia

Keywords

Apnoeic oxygenation; Airway management; Intensive care; Critical care

Outcome Measures

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.

  5 minutes post intubation

Secondary Outcomes (11)

• Frequency of complications

  5 minutes

• Change of intubation method

  5 minutes

• Intensive care length of stay

  30 days

• ETCO2 in the first breath after intubation

  5 minutes

• Duration of intubation

  5 minutes

Study Arms (2)

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

Interventions

Optiflow Switch DEVICE

High flow nasal oxygen with the Optiflow Switch device

High Flow Nasal Oxygen and Tight facemask/ NIV

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adult, ≥18 years old
• Intensive care patients that require tracheal intubation for any indication

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Stockholm: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, Stockholm County, 17176, Sweden

RECRUITING

MeSH Terms

Conditions

Critical Illness; Respiratory Insufficiency; Multiple Organ Failure; Hypoxia

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Shock; Signs and Symptoms, Respiratory; Signs and Symptoms

Central Study Contacts

Ida-Maria Forsberg, PhD

CONTACT

+ 46704381445; ida-maria.forsberg@regionstockholm.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: May 31, 2023
• Study Start: September 25, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 11, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)