Endotrol-tracheal Tube Assisted Endotracheal Intubation During Video Laryngoscopy

NCT01099969 | Completed Results

• 1 other identifier: HSC-MS-09-0456
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the safety and efficacy of Endotrol Tube compared to the conventional endotracheal tube in conjunction with the GlideRite stylet (Verathon Medical Inc, USA) during videolaryngoscopy assisted endotracheal intubation using a McGrath (Aircraft Medical Ltd., and distributed in the US by LMA North America, Inc.) video laryngoscope or a GlideScope (Verathon Medical Inc, USA). The investigators hypothesize that using the Endotrol tracheal tube, (Covidien, Colorado, USA) is safer and more efficacious than using the conventional endotracheal tube during McGrath video laryngoscope and/or GlideScope aided endotracheal intubation.

Conditions

Endotracheal Intubation

Keywords

Endotrol Endotracheal tube; Regular endotracheal tube; gliderite stylet; McGrath videolaryngoscope; Glidescope

Outcome Measures

Primary Outcomes (3)

• Intubation Time

  Intubation time is the time from insertion of the laryngoscope to detection of CO2 on the capnogram.

  time from insertion of the laryngoscope to detection of CO2 on the capnogram

• Number of Intubation Attempts

  at the time of placement of the endotracheal tube

• Number of Difficult Intubations

  Ease of intubation was subjectively assessed by the operator on a scale from 1 to 5 (1 = extremely easy, 2 = easy, 3 = neutral, 4 = difficult, 5 = extremely difficult). A score of 4 or 5 was characterized as "difficult."

  at the time of placement of the endotracheal tube

Secondary Outcomes (1)

• Cormack and Lehane Grade of Laryngeal View

  at the time of intubation

Study Arms (4)

Glidescope with non-styletted Endotrol ETT

EXPERIMENTAL

The patients in this arm will be intubated using a Glidescope videolaryngoscope with non-styletted Endotrol endotracheal tube (ETT).

Device: Glidescope videolaryngoscope; Device: Non-styletted Endotrol endotracheal tube (ETT)

Glidescope with styletted regular ETT

ACTIVE COMPARATOR

The patientsin this arm will be intubated using the glidescope videolaryngoscope and regular endotracheal tube (ETT) with gliderite stylet.

Device: Glidescope videolaryngoscope; Device: Regular endotracheal tube (ETT) with Gliderite stylet

McGrath with non-styletted Endotrol ETT

EXPERIMENTAL

The patients in this arm will be intubated using McGrath videolaryngoscope and non-styletted Endotrol endotracheal tube (ETT).

Device: McGrath videolaryngoscope; Device: Non-styletted Endotrol endotracheal tube (ETT)

McGrath with with styletted regular ETT

ACTIVE COMPARATOR

The patients receiving this arm will be intubation using McGrath videolaryngoscope and regular endotracheal tube (ETT) with Gliderite stylet.

Device: McGrath videolaryngoscope; Device: Regular endotracheal tube (ETT) with Gliderite stylet

Interventions

Glidescope videolaryngoscope DEVICE

Glidescope with non-styletted Endotrol ETT; Glidescope with styletted regular ETT

McGrath videolaryngoscope DEVICE

McGrath with non-styletted Endotrol ETT; McGrath with with styletted regular ETT

Non-styletted Endotrol endotracheal tube (ETT) DEVICE

Glidescope with non-styletted Endotrol ETT; McGrath with non-styletted Endotrol ETT

Regular endotracheal tube (ETT) with Gliderite stylet DEVICE

Glidescope with styletted regular ETT; McGrath with with styletted regular ETT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-80 years old
• ASA: I-III
• Mallampati: I-III
• Mouthopening: 2 FB or \< 4 cm

You may not qualify if:

• Age \< 18 years or \> 80 years
• ASA: IV
• Mallampati: IV
• Mouthopening \< 2 FB 4cm
• No risk for aspiration
• No respiratory infection in past 10 days

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Limitations and Caveats

small sample size; study not controlled for the residents' personal experience, and some performed more intubations compared to others; ease of intubation was assessed subjectively by the operator who was unblinded to the modality used.

Results Point of Contact

• Title: Dr. Davide Cattano
• Organization: The University of Texas Health Science Center at Houston

davide.cattano@uth.tmc.edu

713.500.6235

Study Officials

• Davide Cattano, M.D.,PhD

  The University of Texas Medical School at Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor - Anesthesiology

Study Record Dates

• First Submitted: April 1, 2010
• First Posted: April 8, 2010
• Study Start: March 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: June 4, 2018
• Results First Posted: June 4, 2018

Record last verified: 2018-05

Locations

US (1)