Intubation in Coronavirus Disease 19 With Level 3 PPE

Sponsor

Indonesia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05108584

Collaborator

(none)

Enrollment

Location

Arms

2.7

Anticipated Duration (Months)

14.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intubation Complication	Procedure: PPE Level 3 and Video Laryngoscope Procedure: PPE Level 3 and Direct Laryngoscope Procedure: PPE Level 2 and Direct Laryngoscope	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

39 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Intubation Procedure in COVID-19 Pandemic

Actual Study Start Date :

Nov 19, 2021

Anticipated Primary Completion Date :

Jan 4, 2022

Anticipated Study Completion Date :

Feb 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Procedure: PPE Level 3 and Video Laryngoscope The operator used level 3 PPE and video laryngoscope for the intubation process
Experimental: 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.	Procedure: PPE Level 3 and Direct Laryngoscope The operator used level 3 PPE and direct laryngoscope for the intubation process
Experimental: 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.	Procedure: PPE Level 2 and Direct Laryngoscope The operator used level 2 PPE and direct laryngoscope for the intubation process

Arm

Intervention/Treatment

Experimental: 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.

Procedure: PPE Level 3 and Video Laryngoscope

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

Experimental: 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.

Procedure: PPE Level 3 and Direct Laryngoscope

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

Experimental: 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.

Procedure: PPE Level 2 and Direct Laryngoscope

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

Outcome Measures

Primary Outcome Measures

Total duration of the intubation process [During the procedure]
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
Success of intubation process as assessed by number of trials [During the procedure]
The sum amount of trials needed to successfully place an endotracheal tube to the respiratory system
Safety as assessed by number of participants experiencing complications [During the procedure]
Number of participants who experience desaturation of oxygen (below 95%), airway injury, increased blood pressure (over 120/80 mmHg)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 59 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cipto Mangunkusumo Hospital	Jakarta Pusat	DKI Jakarta	Indonesia	10430

Sponsors and Collaborators

Indonesia University

Investigators

Principal Investigator: Dita Aditianingsih, Indonesia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dita Aditianingsih, MD, PhD, Anesthesiologist Consultant, Indonesia University

ClinicalTrials.gov Identifier:

NCT05108584

Other Study ID Numbers:

IndonesiaU120

First Posted:

Nov 5, 2021

Last Update Posted:

Dec 1, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Dita Aditianingsih, MD, PhD, Anesthesiologist Consultant, Indonesia University

COVID-19

Intubation process

Personal protective equipment (PPE)

Laryngoscope

Study Results

No Results Posted as of Dec 1, 2021