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NCT Number: NCT04411056

A Study Comparing Time to Intubate With and Without a 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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Robert Packer Hospital

Sayre, Pennsylvania, 18840, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients presenting for surgery needing general anesthesia with endotracheal intubation
  • pre-operatively tested negative for SARS- CoV-2 virus

Exclusion criteria

  • 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
  • known or anticipated difficult airway
  • patients with positive COVID status or unknown COVID status
  • patients who reported claustrophobia in the pre-operative area

Treatment and study plan

Barrier box

Other

Placement of barrier box ( a plastic box for shielding)

Primary outcomes

  1. 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.

Secondary outcomes

  1. Intubation in First Attempt

    Time frame: up to 2 minutes during intubation before surgery

    All participants were intubated successfully on the first attempt.

  2. Need for Bag Mask Ventilation

    Time frame: up to 5 minutes

    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.

  3. Participants' Lowest Blood Oxygen Level (Lowest Oxygen Saturation During Induction and Intubation)

    Time frame: up to 5 minutes

    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%.

  4. Induction Time

    Time frame: up to 5 minutes

    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.

Other outcomes

  1. Airway Assessment by Mallampati Score (Scale of 0 to 4)

    Time frame: Up to 5 minutes

    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.

  2. Airway Assessment by Thyromental Distance (TMD)

    Time frame: Up to 5 minutes

    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).

  3. Airway Assessment by Inter Incisor Distance

    Time frame: Up to 5 minutes

    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).

  4. Neck Range of Motion

    Time frame: Up to 5 minutes

    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)

Sponsors and collaborators

Lead sponsor

The Guthrie Clinic

Other

Registry information

Official study title

Time to Adapt in the Pandemic Era: A Prospective Randomized Study Comparing Time to Intubate With and Without the Barrier Box

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 2, 2020
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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