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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| No Barrier box | No Intervention | Participants will have routine intubation with no barrier box |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Barrier box | Other | Placement of barrier box ( a plastic box for shielding) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 2 minutes during intubation before surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Intubation in First Attempt | All participants were intubated successfully on the first attempt. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Airway Assessment by Mallampati Score (Scale of 0 to 4) | Airway assessment by Mallampati score (scale of 0 to 4) used to assess and prepare for possible difficult intubation of participants who score high. Lower scores are less likely to have a difficult intubation and higher scores are more likely to have a difficult intubation. Mallampati 0: Any part of the epiglottis is visible Mallampati 1: soft palate, uvula, and pillars are visible Mallampati 2: soft palate and uvula are visible Mallampati 3: only the soft palate and base of the uvula are visible Mallampati 4: only the hard palate is visible. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Praneeth Madabhushi, MD, MHCA | The Guthrie Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Packer Hospital | Sayre | Pennsylvania | 18840 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32928122 | Result | 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. |
| Label | URL |
|---|---|
| Publication PMID 32928122 | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Barrier Box | Participants will have a barrier box placed during intubation Barrier box: Placement of barrier box ( a plastic box for shielding) |
| FG001 | No Barrier Box | Participants will have routine intubation with no barrier box |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Barrier Box | Participants will have a barrier box placed during intubation Barrier box: Placement of barrier box ( a plastic box for shielding) |
| BG001 | No Barrier Box | Participants will have routine intubation with no barrier box |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | seconds | up to 2 minutes during intubation before surgery |
|
One day during the surgery
There were no deaths and no serious adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Barrier Box | Participants will have a barrier box placed during intubation Barrier box: Placement of barrier box ( a plastic box for shielding) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Praneet Madabhushi MD | The Guthrie Clinic | 5708874882 | praneeth.madabhushi@guthrie.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 30, 2020 | Dec 2, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 20, 2024 | Jan 17, 2025 | SAP_001.pdf |
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Participants assigned to barrier box or no barrier box
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| 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%. | 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. | up to 5 minutes |
| Up to 5 minutes |
| Airway Assessment by Thyromental Distance (TMD) | Thyromental Distance (TMD) is the distance from the thyroid notch to the chin when the head is extended. TMD is used to assess and prepare for possible difficult intubation. A distance of greater than 3 finger breadth may be less likely to have a difficult intubation. A distance less than or equal to 3 finger breadth may be more likely to have a difficult intubation. Number of participants with TMD greater than 3 finger breadth will be assessed in both groups (Barrier Box and No Barrier Box). | Up to 5 minutes |
| Airway Assessment by Inter Incisor Distance | Inter incisor distance is the distance between the upper and lower teeth of the open mouth of a patient. Inter incisor distance is used to assess and prepare for possible difficult intubation of participants who are less than or equal to 3 finger breadth. A distance greater than 3 finger breadth may be less likely to have a difficult airway or airway constriction. Number of participants with Inter incisor distance greater than 3 finger breadth will be assessed in both groups (Barrier Box and No Barrier Box). | Up to 5 minutes |
| Neck Range of Motion | Neck range of motion is the degree of movement in the neck - how much the head can flex (bend forward), extend (tilt backwards), and rotate side to side. Neck range of motion helps assess and prepare for possible difficult intubation. Full range of motion is less likely for a difficult intubation. Restricted range of motion indicates a possible difficult intubation. Number of patients with Neck range of motion (categorized as full or restricted) will be assessed in both groups (Barrier Box and No Barrier Box) | Up to 5 minutes |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| American Society of Anesthesiology (ASA) Physical Status | The American Society of Anesthesiology (ASA) Physical Status is used to assess a patient's pre-anesthesia medical condition and helps predict how patients will do during a surgical procedure. A lower ASA score predicts (but does not guarantee) better outcomes during a surgical procedure.
| Count of Participants | Participants |
|
Participants will have routine intubation with no barrier box
|
|
| Secondary | Intubation in First Attempt | All participants were intubated successfully on the first attempt. | Posted | Count of Participants | Participants | up to 2 minutes during intubation before surgery |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | up to 5 minutes |
|
|
|
| Secondary | 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%. | Posted | Mean | Standard Deviation | percentage of blood oxygen | up to 5 minutes |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | seconds | up to 5 minutes |
|
|
|
| Other Pre-specified | Airway Assessment by Mallampati Score (Scale of 0 to 4) | Airway assessment by Mallampati score (scale of 0 to 4) used to assess and prepare for possible difficult intubation of participants who score high. Lower scores are less likely to have a difficult intubation and higher scores are more likely to have a difficult intubation. Mallampati 0: Any part of the epiglottis is visible Mallampati 1: soft palate, uvula, and pillars are visible Mallampati 2: soft palate and uvula are visible Mallampati 3: only the soft palate and base of the uvula are visible Mallampati 4: only the hard palate is visible. | Posted | Count of Participants | Participants | Up to 5 minutes |
|
|
|
| Other Pre-specified | Airway Assessment by Thyromental Distance (TMD) | Thyromental Distance (TMD) is the distance from the thyroid notch to the chin when the head is extended. TMD is used to assess and prepare for possible difficult intubation. A distance of greater than 3 finger breadth may be less likely to have a difficult intubation. A distance less than or equal to 3 finger breadth may be more likely to have a difficult intubation. Number of participants with TMD greater than 3 finger breadth will be assessed in both groups (Barrier Box and No Barrier Box). | Posted | Count of Participants | Participants | Up to 5 minutes |
|
|
|
| Other Pre-specified | Airway Assessment by Inter Incisor Distance | Inter incisor distance is the distance between the upper and lower teeth of the open mouth of a patient. Inter incisor distance is used to assess and prepare for possible difficult intubation of participants who are less than or equal to 3 finger breadth. A distance greater than 3 finger breadth may be less likely to have a difficult airway or airway constriction. Number of participants with Inter incisor distance greater than 3 finger breadth will be assessed in both groups (Barrier Box and No Barrier Box). | Posted | Count of Participants | Participants | Up to 5 minutes |
|
|
|
| Other Pre-specified | Neck Range of Motion | Neck range of motion is the degree of movement in the neck - how much the head can flex (bend forward), extend (tilt backwards), and rotate side to side. Neck range of motion helps assess and prepare for possible difficult intubation. Full range of motion is less likely for a difficult intubation. Restricted range of motion indicates a possible difficult intubation. Number of patients with Neck range of motion (categorized as full or restricted) will be assessed in both groups (Barrier Box and No Barrier Box) | Posted | Count of Participants | Participants | Up to 5 minutes |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | No Barrier Box | Participants will have routine intubation with no barrier box | 0 | 38 | 0 | 38 | 0 | 38 |
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| ASA 3 |
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| Mallampati 2 |
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| Mallampati 3 |
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| Mallampati 4 |
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