Intubation in Coronavirus Disease 19 With Level 3 PPE

NCT ID: NCT05108584

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-19
• Study Completion Date: 2022-02-10

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.

Conditions

Intubation Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1 - Level 3 PPE and video laryngoscope

Pre-anesthesia visit aims to assess the participant's physical status based on the American Society of Anesthesiologists score and assessment of the airway. Researcher then explained about the study and plan for anesthesia using an endotracheal tube and personal protective equipment according to the group. While in the operating room, the intubation operator was assisted by an assistant who already used appropriate PPE. Coveralls or hazmat suits and surgical gowns used must match the size. The intubation operator was resident of Anesthesiology and Intensive Therapy study program (stage II) and accompanied by an independent resident (stage III) and an anesthesiologist on duty. The operator used level 3 PPE (coverall jumpsuit, face shield, goggles, N95 mask, surgical mask, boot, scrub, and two layered gloves) and video laryngoscope for intubation of the participants. Researcher was in charge for recording time and event during the intubation process according to the study form.

Group Type: EXPERIMENTAL

PPE Level 3 and Video Laryngoscope

Intervention Type: PROCEDURE

The operator used level 3 PPE and video laryngoscope for the intubation process

Group 2 - Level 3 PPE and direct laryngoscope

Pre-anesthesia visit aims to assess the participant's physical status based on the American Society of Anesthesiologists score and assessment of the airway. Researcher then explained about the study and plan for anesthesia using an endotracheal tube and personal protective equipment according to the group. While in the operating room, the intubation operator was assisted by an assistant who already used appropriate PPE. Coveralls or hazmat suits and surgical gowns used must match the size. The intubation operator was resident of Anesthesiology and Intensive Therapy study program (stage II) and accompanied by an independent resident (stage III) and an anesthesiologist on duty. The operator used level 3 PPE (coverall jumpsuit, face shield, goggles, N95 mask, surgical mask, boot, scrub, and two layered gloves) and direct laryngoscope for intubation of the participants. Researcher was in charge for recording time and event during the intubation process according to the study form.

Group Type: EXPERIMENTAL

PPE Level 3 and Direct Laryngoscope

Intervention Type: PROCEDURE

The operator used level 3 PPE and direct laryngoscope for the intubation process

Group 3 - Level 2 PPE and direct laryngoscope

Pre-anesthesia visit aims to assess the participant's physical status based on the American Society of Anesthesiologists score and assessment of the airway. Researcher then explained about the study and plan for anesthesia using an endotracheal tube and personal protective equipment according to the group. While in the operating room, the intubation operator was assisted by an assistant who already used appropriate PPE. Coveralls or hazmat suits and surgical gowns used must match the size. The intubation operator was resident of Anesthesiology and Intensive Therapy study program (stage II) and accompanied by an independent resident (stage III) and an anesthesiologist on duty. The operator used level 2 PPE (surgical gown/apron, face shield, goggles, N95 mask, surgical mask, boot, scrub, and two layered gloves) and video laryngoscope for intubation of the participants. Researcher was in charge for recording time and event during the intubation process according to the study form.

Group Type: EXPERIMENTAL

PPE Level 2 and Direct Laryngoscope

Intervention Type: PROCEDURE

The operator used level 2 PPE and direct laryngoscope for the intubation process

Interventions

PPE Level 3 and Video Laryngoscope

The operator used level 3 PPE and video laryngoscope for the intubation process

Intervention Type: PROCEDURE

PPE Level 3 and Direct Laryngoscope

The operator used level 3 PPE and direct laryngoscope for the intubation process

Intervention Type: PROCEDURE

PPE Level 2 and Direct Laryngoscope

The operator used level 2 PPE and direct laryngoscope for the intubation process

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Dita Aditianingsih

MD, PhD, Anesthesiologist Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dita Aditianingsih

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Locations

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

Countries

Indonesia

Other Identifiers

IndonesiaU120

Identifier Type: -

Identifier Source: org_study_id