Intubation ComplicationNCT05108584
Intubation in Coronavirus Disease 19 With Level 3 PPE
A study testing PPE Level 3 and Video Laryngoscope, PPE Level 3 and Direct Laryngoscope and PPE Level 2 and Direct Laryngoscope in people with Intubation Complication, run by Universitas Indonesia at 1 site in Indonesia.
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%. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Intubation Complication
- What is being tested?
- PPE Level 3 and Video Laryngoscope, PPE Level 3 and Direct Laryngoscope and PPE Level 2 and Direct Laryngoscope
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteIndonesia
- Study dates
- 19 Nov 2021to 10 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 59 years old
- Undergo elective or emergency surgery using general anesthesia with endotracheal tube
- BMI below 30 kg/m2
Who cannot join
- Airway difficulty as assessed by preoperative assessment
- Critical patients with unstable hemodynamics
- Suspected or confirmed COVID-19 with ASA 3-5
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: The Intubation Procedure in COVID-19 Pandemic
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
- Being tested
- PPE Level 3 and Video Laryngoscope, PPE Level 3 and Direct Laryngoscope, PPE Level 2 and Direct Laryngoscope
- Keywords
- COVID-19, Intubation process, Personal protective equipment (PPE), Laryngoscope
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPE Level 3 and Video LaryngoscopeProcedure or surgery
The operator used level 3 PPE and video laryngoscope for the intubation process
PPE Level 3 and Direct LaryngoscopeProcedure or surgery
The operator used level 3 PPE and direct laryngoscope for the intubation process
PPE Level 2 and Direct LaryngoscopeProcedure or surgery
The operator used level 2 PPE and direct laryngoscope for the intubation process
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Level 3 PPE and video laryngoscope | Experimental | 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. Receives: Procedure: PPE Level 3 and Video Laryngoscope |
| Group 2 - Level 3 PPE and direct laryngoscope | Experimental | 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. Receives: Procedure: PPE Level 3 and Direct Laryngoscope |
| Group 3 - Level 2 PPE and direct laryngoscope | Experimental | 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. Receives: Procedure: PPE Level 2 and Direct Laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During the procedure
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
Measured: During the procedure
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)
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start19 Nov 2021
- Primary completion4 Jan 2022
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation ComplicationStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dita Aditianingsih, Universitas Indonesia
- Investigators
- Dita Aditianingsih, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108584
- Sponsor's protocol ID
- IndonesiaU120
- Status last verified
- May 2025
- First submitted
- 18 Oct 2021
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Intubation Procedure in COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT05108584
- Acronym / sponsor ID
- IndonesiaU120
- Conditions
- Intubation Complication
- Keywords
- COVID-19, Intubation process, Personal protective equipment (PPE), Laryngoscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- 4 Jan 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Level 3 PPE and video laryngoscope | Experimental | Procedure: PPE Level 3 and Video LaryngoscopePre-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 2 - Level 3 PPE and direct laryngoscope | Experimental | Procedure: PPE Level 3 and Direct LaryngoscopePre-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 3 - Level 2 PPE and direct laryngoscope | Experimental | Procedure: PPE Level 2 and Direct LaryngoscopePre-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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18 to 59 years old
- Undergo elective or emergency surgery using general anesthesia with endotracheal tube
- BMI below 30 kg/m2
Key exclusion criteria (3 listed)
- Airway difficulty as assessed by preoperative assessment
- Critical patients with unstable hemodynamics
- Suspected or confirmed COVID-19 with ASA 3-5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PPE Level 3 and Video LaryngoscopeThe operator used level 3 PPE and video laryngoscope for the intubation process | Procedure or surgery | Group 1 - Level 3 PPE and video laryngoscope |
| PPE Level 3 and Direct LaryngoscopeThe operator used level 3 PPE and direct laryngoscope for the intubation process | Procedure or surgery | Group 2 - Level 3 PPE and direct laryngoscope |
| PPE Level 2 and Direct LaryngoscopeThe operator used level 2 PPE and direct laryngoscope for the intubation process | Procedure or surgery | Group 3 - Level 2 PPE and direct laryngoscope |
Primary outcome
Total duration of the intubation process
Time frame: 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
Time frame: 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
Time frame: During the procedure
Number of participants who experience desaturation of oxygen (below 95%), airway injury, increased blood pressure (over 120/80 mmHg)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Individual participant dataSharing planned: Yes
Related trials for Intubation Complication
Recruiting
Smart Checklist Implementation for Pediatric Tracheal Intubations in the ICU- Multicenter Study
Intubation Complication
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The ED-AWARENESS-2 Trial
Awareness, Mechanical Ventilation
RecruitingObservational study
Cardiovascular History and Hemodynamic Complications After Intubation in ICU
Hemodynamic Complications
Not yet recruiting
Postoperative Pulmonary Complications After Use of Supraglottic Airway Devices and Neuromuscular Blockade
Postoperative Pulmonary Complications
Not yet recruiting
Establish Whether Hyperangulated Videolaryngoscopy (HAVL) Can be Used to Facilitate Tracheal Intubation Effectively and Safely in Unselected Adult Patients; Describe the Population in Whom HAVL Fails to Facilitate Tracheal Intubation Successfully, Identifying Any Contributory Characteristics.
Intubation Skill, Intubation Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dita Aditianingsih principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PPE Level 3 and Video Laryngoscope, PPE Level 3 and Direct Laryngoscope and PPE Level 2 and Direct Laryngoscope in people with Intubation Complication, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total duration of the intubation process (time frame: During the procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.