Facilitating EndotracheaL Intubation by Laryngoscopy Technique and Apneic Oxygenation Within the Intensive Care Unit: The FELLOW Study

NCT ID: NCT02051816

Last Updated: 2017-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-02-28

Brief Summary

Respiratory failure requiring endotracheal intubation occurs in as many as 40% of critically ill patients. Procedural complications including failed attempts at intubation, esophageal intubation, arterial oxygen desaturation, aspiration, hypotension, cardiac arrest, and death are common in this setting. While there are many important components of successful airway management in critical illness, the maintenance of adequate arterial hemoglobin saturation from procedure initiation until endotracheal tube placement is paramount as desaturation is the most common factor associated with peri-intubation cardiac arrest and death. Interventions that either shorten the duration of time required for tube placement or prolong the period before desaturation may be effective in improving outcome. The high rate of complications and the lack of existing evidence regarding the efficacy of current airway management techniques in shortening the time to airway establishment or prolonging the time to desaturation mandates further investigation. The primary hypothesis is that video laryngoscopy will be superior to direct laryngoscopy in successful first attempt at endotracheal intubation (defined by confirmed placement of an endotracheal tube in the trachea during first laryngoscopy attempt) of medical ICU patients by Pulmonary/Critical Care Medicine fellows after controlling for the operator's past number of procedures with the equipment used. Also, the investigators hypothesize that the provision of apneic oxygenation during the endotracheal intubation procedure (defined as a nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure) will result in a higher arterial oxygen saturation nadir (defined as lowest noninvasive oxygenation saturation value observed between the administration of sedation and/or neuromuscular blockade and 2 minutes after successfully secured airway or death) compared to no apneic oxygenation.

Conditions

Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

VL and AO

Video laryngoscopy and apneic oxygenation

Group Type: ACTIVE_COMPARATOR

Apneic Oxygenation

Intervention Type: DEVICE

No Apneic Oxygenation

Intervention Type: DEVICE

DL and AO

Direct Laryngoscopy and apneic oxygenation

Group Type: ACTIVE_COMPARATOR

Apneic Oxygenation

Intervention Type: DEVICE

No Apneic Oxygenation

Intervention Type: DEVICE

VL and no AO

Video Laryngoscopy and no apneic oxygenation

Group Type: ACTIVE_COMPARATOR

Video Laryngoscopy

Intervention Type: DEVICE

Direct Laryngoscopy

Intervention Type: DEVICE

DL and no AO

Direct Laryngoscopy and no apneic oxygenation

Group Type: ACTIVE_COMPARATOR

Video Laryngoscopy

Intervention Type: DEVICE

Direct Laryngoscopy

Intervention Type: DEVICE

Interventions

Video Laryngoscopy

Intervention Type: DEVICE

Apneic Oxygenation

Intervention Type: DEVICE

Direct Laryngoscopy

Intervention Type: DEVICE

No Apneic Oxygenation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adults
• Medical ICU Patients
• Require endotracheal intubation
• Endotracheal intubation to be performed by Pulmonary/Critical Care Medicine Fellow
• Sedation and/or neuromuscular blockade is planned for the procedure

Exclusion Criteria

• Operators other than Pulmonary/Critical Care Medicine Fellows
• The operator predetermines that the patient requires specific intubating equipment or oxygenation technique will be required for the safe performance of the procedure

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

David Janz

Clinical Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew W Semler, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Todd W Rice, MD, MSc

Role: STUDY_CHAIR

Vanderbilt University

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

References

Semler MW, Janz DR, Lentz RJ, Matthews DT, Norman BC, Assad TR, Keriwala RD, Ferrell BA, Noto MJ, McKown AC, Kocurek EG, Warren MA, Huerta LE, Rice TW; FELLOW Investigators; Pragmatic Critical Care Research Group. Randomized Trial of Apneic Oxygenation during Endotracheal Intubation of the Critically Ill. Am J Respir Crit Care Med. 2016 Feb 1;193(3):273-80. doi: 10.1164/rccm.201507-1294OC.

Reference Type: DERIVED

PMID: 26426458 (View on PubMed)

Other Identifiers

131966

Identifier Type: -

Identifier Source: org_study_id