IntubationNCT04411056
A Study Comparing Time to Intubate With and Without a Barrier Box
A study testing Barrier box in people with Intubation, run by The Guthrie Clinic at 1 site in United States.
Trial summary
This study is for patients who will be having surgery and will have a breathing tube placed during intubation. The purpose of the research is to study the time it takes to use a barrier box for placement of a breathing tube. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation
- What is being tested?
- Barrier box
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2020to 25 May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients presenting for surgery needing general anesthesia with endotracheal intubation
- pre-operatively tested negative for SARS- CoV-2 virus
Who cannot join
- inability to consent or cooperate,
- children
- pregnant women
- patients with severe cardiopulmonary compromise
- American Society Anesthesiologists' (ASA) physical status 4 and 5
- Body Mass Index (BMI) >35
Show all 9Show fewer
- known or anticipated difficult airway
- patients with positive COVID status or unknown COVID status
- patients who reported claustrophobia in the pre-operative area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Time to Adapt in the Pandemic Era: A Prospective Randomized Study Comparing Time to Intubate With and Without the Barrier Box
This study is for patients who will be having surgery and will have a breathing tube placed during intubation. The purpose of the research is to study the time it takes to use a barrier box for placement of a breathing tube. A barrier box is a clear box that sits over the head and shoulders of a patient as a breathing tube is placed. The box is used to protect the healthcare provider's exposure to coronavirus in patients who have COVID-19. The study will not include patients who test positive for COVID-19 or who are sick with COVID-19 symptoms. The researchers want to learn how long it takes to use the barrier box before it is used routinely in COVID-19 patients.
Read the detailed description
The study will have two groups of 39 patients in each group. Some patients will have a barrier box and some patients will not have a barrier box. Patients will be randomly assigned to the barrier box or no barrier box group. The study will measure the time it takes to place the breathing tube.
- Conditions
- Intubation
- Being tested
- Barrier box
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barrier boxOther
Placement of barrier box ( a plastic box for shielding)
| Study group | Role | What they receive |
|---|---|---|
| Barrier box | Experimental | Participants will have a barrier box placed during intubation for a medical procedure. A barrier box is a medical device which was in use from May 1, 2020 to August 20, 2020 during the COVID-19 pandemic. The device is a barrier enclosure to protect healthcare providers caring for or performing medical procedures (such as intubation) on patients who are known or suspected to have COVID-19. Receives: Other: Barrier box |
| No Barrier box | No intervention | Participants will have routine intubation with no barrier box |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Intubate
Time to intubate refers to the time it takes to insert a tube into a patient's trachea to help them breathe. Intubation is a procedure routinely used before surgery to help keep the airway open. The study will compare the time to intubate in two groups, barrier box and no barrier box. In medical terms, time to intubate is the time from loss of twitches confirmed with a peripheral nerve stimulator to confirmation of end tidal carbon dioxide.
Measured: up to 2 minutes during intubation before surgery
Secondary outcomes (4)
Intubation in First Attempt
All participants were intubated successfully on the first attempt.
Measured: up to 2 minutes during intubation before surgery
Need for Bag Mask Ventilation
During induction time, there were no patients who needed bag mask ventilation. Bag mask ventilation is a technique used to provide oxygen and ventilation to patients who are not breathing adequately. Induction is the process of transitioning a patient from consciousness to unconsciousness at the beginning of a general anesthetic. The induction time is defined in medical terms as the time taken from propofol bolus to loss of twitches measured with a peripheral nerve stimulator.
Measured: up to 5 minutes
Participants' Lowest Blood Oxygen Level (Lowest Oxygen Saturation During Induction and Intubation)
During process of inserting a tube in a patient's trachea (intubation) before surgery and the process of being given anesthesia (induction), there is a point where a patient's blood oxygen level drops to its lowest point during the process. This is referred to as the lowest oxygen saturation. In medical terms this is the lowest peripheral capillary oxygen saturation during the induction time defined as the time taken from propofol bolus to loss of twitches measured with a peripheral nerve stimulator.
The maximum blood oxygen level is 100%. Normal range is 95% - 100%. Low oxygen level (hypoxemia)is below 95%.
Measured: up to 5 minutes
Induction Time
Induction is the process of transitioning a patient from consciousness to unconsciousness at the beginning of a general anesthetic. The induction time is defined in medical terms as the time taken from propofol bolus to loss of twitches measured with a peripheral nerve stimulator.
Measured: up to 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start7 May 2020
- Primary completion19 May 2020
- Study completion25 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IntubationStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants assigned to barrier box or no barrier box
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Guthrie Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Praneeth Madabhushi, MD, MHCA, Principal investigator, The Guthrie Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04411056
- Sponsor's protocol ID
- 2004-38
- Status last verified
- Jan 2025
- First submitted
- 27 May 2020
- Last updated
- 22 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Madabhushi P, Kinthala S, Ankam A, Chopra N, Porter BR. Time to adapt in the pandemic era: a prospective randomized non -inferiority study comparing time to intubate with and without the barrier box. BMC Anesthesiol. 2020 Sep 14;20(1):232. doi: 10.1186/s12871-020-01149-w.
PubMed 32928122
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time to Adapt in the Pandemic Era: A Prospective Randomized Study Comparing Time to Intubate With and Without the Barrier Box
- ClinicalTrials.gov ID
- NCT04411056
- Acronym / sponsor ID
- 2004-38
- Conditions
- Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- The Guthrie ClinicUniversity, hospital or other
- Study start
- 7 May 2020 (actual)
- Primary completion
- 19 May 2020 (actual)
- Study completion
- 25 May 2020 (actual)
- First posted
- 2 Jun 2020 (actual)
- Results
- Posted 22 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is for patients who will be having surgery and will have a breathing tube placed during intubation. The purpose of the research is to study the time it takes to use a barrier box for placement of a breathing tube. A barrier box is a clear box that sits over the head and shoulders of a patient as a breathing tube is placed. The box is used to protect the healthcare provider's exposure to coronavirus in patients who have COVID-19. The study will not include patients who test positive for COVID-19 or who are sick with COVID-19 symptoms. The researchers want to learn how long it takes to use the barrier box before it is used routinely in COVID-19 patients.
Detailed description
The study will have two groups of 39 patients in each group. Some patients will have a barrier box and some patients will not have a barrier box. Patients will be randomly assigned to the barrier box or no barrier box group. The study will measure the time it takes to place the breathing tube.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants assigned to barrier box or no barrier box
| Arm | Type | Receives |
|---|---|---|
| Barrier box | Experimental | Other: Barrier boxParticipants will have a barrier box placed during intubation for a medical procedure. A barrier box is a medical device which was in use from May 1, 2020 to August 20, 2020 during the COVID-19 pandemic. The device is a barrier enclosure to protect healthcare providers caring for or performing medical procedures (such as intubation) on patients who are known or suspected to have COVID-19. |
| No Barrier box | No intervention | –Participants will have routine intubation with no barrier box |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients presenting for surgery needing general anesthesia with endotracheal intubation
- pre-operatively tested negative for SARS- CoV-2 virus
Key exclusion criteria (9 listed)
- inability to consent or cooperate,
- children
- pregnant women
- patients with severe cardiopulmonary compromise
- American Society Anesthesiologists' (ASA) physical status 4 and 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 |
|---|---|---|
| Barrier boxPlacement of barrier box ( a plastic box for shielding) | Other | Barrier box |
Primary outcome
Time to Intubate
Time frame: up to 2 minutes during intubation before surgery
Time to intubate refers to the time it takes to insert a tube into a patient's trachea to help them breathe. Intubation is a procedure routinely used before surgery to help keep the airway open. The study will compare the time to intubate in two groups, barrier box and no barrier box. In medical terms, time to intubate is the time from loss of twitches confirmed with a peripheral nerve stimulator to confirmation of end tidal carbon dioxide.
4 secondary outcomes
Intubation in First Attempt
Time frame: up to 2 minutes during intubation before surgery
Need for Bag Mask Ventilation
Time frame: up to 5 minutes
Participants' Lowest Blood Oxygen Level (Lowest Oxygen Saturation During Induction and Intubation)
Time frame: up to 5 minutes
Induction Time
Time frame: up to 5 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32928122Madabhushi P, Kinthala S, Ankam A, Chopra N, Porter BR. Time to adapt in the pandemic era: a prospective randomized non -inferiority study comparing time to intubate with and without the barrier box. BMC Anesthesiol. 2020 Sep 14;20(1):232. doi: 10.1186/s12871-020-01149-w.
- Publication PMID 32928122Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Intubation
Active, not recruiting
OR Video-Laryngoscope Evaluations
Video Laryngoscopy, Quality Improvement
Not yet recruiting
AI Smart Glasses Feedback for Intubation Training in Medical Students
Intubation, Intratracheal, Medical Education
Not yet recruiting
Effect of a Brief Educational Intervention on Endotracheal Tube Cuff Pressure
Intubation, Endotracheal Tube Cuff Pressure
Recruiting
Smart Checklist Implementation for Pediatric Tracheal Intubations in the ICU- Multicenter Study
Intubation Complication
Not yet recruitingObservational study
Patient State Index at Laryngoscopy and Tracheal Intubation Conditions
Anesthesia, Intubation, Endotracheal
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.
Praneeth Madabhushi, MD, MHCA principal investigator
The Guthrie Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Barrier box in people with Intubation, run by The Guthrie Clinic at 1 site in United States.
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 2 inclusion and 9 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 22 Jan 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 United States. 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?
Yes. Results are posted in the registry (first posted 22 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time to Intubate (time frame: up to 2 minutes during intubation before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04411056, which also lists 1 linked publication.
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 22 Jan 2025.