Clinical trial NCT05108584: Intubation in Coronavirus Disease 19 With Level 3 PPE
Official title: The Intubation Procedure in COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation Complication
Keywords: COVID-19
Intubation process
Personal protective equipment (PPE)
Laryngoscope
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2021-11-05
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The World Health Organization (WHO) declared COVID-19 as a pandemic in April 2020. COVID-19 first discovered in Wuhan, China in December 2019. As of May 4th, 2020, the total number of patients in China was 82,880, the number of deaths was 4,633, the death rate was 3.7%. In Indonesia, until May 4th 2020, there were 11,192 confirmed cases of COVID-19 with a total of 845 deaths. High transmission and death due to the severe acute respiratory syndrome coronavirus 2, patients with respiratory failure symptoms were suspected of having COVID-19 until declared negative. A potential and continuing threatening complication is acute respiratory failure. Patient with Acute Respiratory Distress Syndrome (ARDS) require both respiratory support and oxygen therapy. The choosing of endotracheal intubation is generally indicated in moderate to severe ARDS. Apart from respiratory failure, endotracheal intubation is also commonly performed in patients undergoing surgical procedures under general anesthesia for the management of the patient's airway. To prevent transmission to medical personnel, intubation is carried out using PPE according to the guidelines. Guidance for intubation in COVID-19 patients is recommended to use a video laryngoscope because it offers several advantages such as assisting glottis visualization and making the intubation operator more distant from the patient's mouth when compared to direct laryngoscopes. This study aims to see the effect of using PPE and the type of laryngoscope on the intubation process carried out in the COVID-19 pandemic. This study is a preliminary study aimed at seeing the effect size of the recommended PPE use on the process and success of intubation.


Eligibility criteria: Inclusion Criteria:

* Age 18 to 59 years old
* Undergo elective or emergency surgery using general anesthesia with endotracheal tube
* BMI below 30 kg/m2

Exclusion Criteria:

* Airway difficulty as assessed by preoperative assessment
* Critical patients with unstable hemodynamics
* Suspected or confirmed COVID-19 with ASA 3-5

Primary outcomes:
measure: Total duration of the intubation process
timeFrame: During the procedure
measure: Success of intubation process as assessed by number of trials
timeFrame: During the procedure
measure: Safety as assessed by number of participants experiencing complications
timeFrame: During the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Dita Aditianingsih
role: PRINCIPAL_INVESTIGATOR
References: