A Study Comparing Time to Intubate With and Without a Barrier Box

NCT04411056 | Completed Results

• 1 other identifier: 2004-38
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Intubation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Intubation in First Attempt

  up to 2 minutes during intubation before surgery

• Need for Bag Mask Ventilation

  up to 5 minutes

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

  up to 5 minutes

• Induction Time

  up to 5 minutes

Other Outcomes (4)

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

  Up to 5 minutes

• Airway Assessment by Thyromental Distance (TMD)

  Up to 5 minutes

• Airway Assessment by Inter Incisor Distance

  Up to 5 minutes

Study Arms (2)

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.

Other: Barrier box

No Barrier box

NO INTERVENTION

Participants will have routine intubation with no barrier box

Interventions

Barrier box OTHER

Placement of barrier box ( a plastic box for shielding)

Barrier box

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Guthrie Clinic: lead

Study Sites (1)

Robert Packer Hospital

Sayre, Pennsylvania, 18840, United States

Location

Related Publications (1)

• 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.

  PMID: 32928122 RESULT

Related Links

• Publication PMID 32928122

Results Point of Contact

• Title: Praneet Madabhushi MD
• Organization: The Guthrie Clinic

praneeth.madabhushi@guthrie.org

5708874882

Study Officials

• Praneeth Madabhushi, MD, MHCA

  The Guthrie Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants assigned to barrier box or no barrier box

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 2, 2020
• Study Start: May 7, 2020
• Primary Completion: May 19, 2020
• Study Completion: May 25, 2020
• Last Updated: January 22, 2025
• Results First Posted: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)