Intubation in Coronavirus Disease 19 With Level 3 PPE

Intubation Complication Clinical Trial

Official title:

The Intubation Procedure in COVID-19 Pandemic

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05108584
• Other study ID #: IndonesiaU120
• Status: Recruiting
• Phase: N/A
• Start date: November 19, 2021
• Est. completion date: February 10, 2022

Study information

• Verified date: November 2021
• Source: Indonesia University
• Contact: Dita Aditianingsih
• Phone: +6281316114154
• Email: ditaaditia[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: February 10, 2022
• Est. primary completion date: January 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Intubation Complication

Intervention

Procedure:
• PPE Level 3 and Video Laryngoscope
The operator used level 3 PPE and video laryngoscope for the intubation process
• PPE Level 3 and Direct Laryngoscope
The operator used level 3 PPE and direct laryngoscope for the intubation process
• PPE Level 2 and Direct Laryngoscope
The operator used level 2 PPE and direct laryngoscope for the intubation process

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total duration of the intubation process	The sum amount of time needed to complete an intubation process that includes preoxygenation duration, neuromuscular blocker action, laryngoscopy duration, and endotracheal tube position confirmation with ultrasound	During the procedure
Primary	Success of intubation process as assessed by number of trials	The sum amount of trials needed to successfully place an endotracheal tube to the respiratory system	During the procedure
Primary	Safety as assessed by number of participants experiencing complications	Number of participants who experience desaturation of oxygen (below 95%), airway injury, increased blood pressure (over 120/80 mmHg)	During the procedure