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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05883137
Other study ID # 2023-0063201
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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