Effect of Endotracheal Tube Plus STYLET Versus Endotracheal Tube Alone

NCT04079387 | Completed DMC

• 1 other identifier: RECHMPL19_0216
• Study Type: interventional
• Target: 1,040
• Locations: 1 country
• Sites: 1

Brief Summary

Patients admitted to Intensive Care Units (ICU) often require respiratory support. Orotracheal intubation is one of the most frequent procedures performed in ICU.When performed in emergency settings, intubation is a challenging issue as it may be associated with life-threatening complications in up to one third of cases Using a preshaped endotracheal tube plus stylet may have potential advantages over endotracheal tube alone without stylet. The stylet is a rigid but malleable introducer which fits inside the endotracheal tube and allows for manipulation of the tube shape; usually into a hockey stick shape, to facilitate passage of the tube through the laryngeal inlet. The stylet can help to increase success of intubation in operating rooms

Conditions

Intubation Complication; Critically Ill

Outcome Measures

Primary Outcomes (1)

• Number of patients with successful first-pass orotracheal intubation

  the proportion of patients with successful first-pass orotracheal intubation

  At intubation

Secondary Outcomes (1)

• Complications related to intubation

  1 hour after intubation

Other Outcomes (25)

• Lowest SpO2 up to 24 hours after intubation

  up to 24 hours after intubation

• Highest positive end expiratory pressure (PEEP) up to 24 hours after intubation

  up to 24 hours after intubation

• Highest fraction of inspired oxygen (FiO2) up to 24 hours after intubation

  up to 24 hours after intubation

Study Arms (2)

ENDOTRACHEAL TUBE + STYLET

EXPERIMENTAL

The experimental group consists in intubating the trachea with an endotracheal tube + stylet with a "straight-to-cuff" shape and a bend angle of 25° to 35°.

Device: ENDOTRACHEAL TUBE + STYLET

ENDOTRACHEAL TUBE ALONE

ACTIVE COMPARATOR

The control group consists in intubating the trachea with an endotracheal tube alone (i.e, without stylet).

Device: ENDOTRACHEAL TUBE ALONE

Interventions

ENDOTRACHEAL TUBE + STYLET DEVICE

The experimental group consists in intubating the trachea with an endotracheal tube + stylet with a "straight-to-cuff" shape and a bend angle of 25° to 35°

ENDOTRACHEAL TUBE + STYLET

ENDOTRACHEAL TUBE ALONE DEVICE

intubating the trachea with an endotracheal tube alone

ENDOTRACHEAL TUBE ALONE

Eligibility Criteria

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

You may qualify if:

• Patients must be present in the intensive care unit (ICU) and require mechanical ventilation through an orotracheal tube.
• Adult (age ≥ 18 years)
• Subjects must be covered by public health insurance

You may not qualify if:

• Refusal of study participation or to pursue the study by the patient
• Pregnancy or breastfeeding
• Absence of coverage by the French statutory healthcare insurance system
• protected person
• intubation in case of cardio circulatory arrest
• Previous intubation during the same ICU stay and already included in the study

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Centre Hospitalier Universitaire Montpellier, Saint Eloi

Montpellier, Languedoc-Roussillon, 34295, France

Location

Related Publications (2)

• Jaber S, Rolle A, Godet T, Terzi N, Riu B, Asfar P, Bourenne J, Ramin S, Lemiale V, Quenot JP, Guitton C, Prudhomme E, Quemeneur C, Blondonnet R, Biais M, Muller L, Ouattara A, Ferrandiere M, Saint-Leger P, Rimmele T, Pottecher J, Chanques G, Belafia F, Chauveton C, Huguet H, Asehnoune K, Futier E, Azoulay E, Molinari N, De Jong A; STYLETO trial group. Effect of the use of an endotracheal tube and stylet versus an endotracheal tube alone on first-attempt intubation success: a multicentre, randomised clinical trial in 999 patients. Intensive Care Med. 2021 Jun;47(6):653-664. doi: 10.1007/s00134-021-06417-y. Epub 2021 May 25.

  PMID: 34032882 BACKGROUND

• Jaber S, Rolle A, Jung B, Chanques G, Bertet H, Galeazzi D, Chauveton C, Molinari N, De Jong A. Effect of endotracheal tube plus stylet versus endotracheal tube alone on successful first-attempt tracheal intubation among critically ill patients: the multicentre randomised STYLETO study protocol. BMJ Open. 2020 Oct 7;10(10):e036718. doi: 10.1136/bmjopen-2019-036718.

  PMID: 33033014 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 6, 2019
• Study Start: October 1, 2019
• Primary Completion: March 17, 2020
• Study Completion: June 15, 2020
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 12 months after the main publication
• Access Criteria: Data are provided to qualified investigators free of charge. Required documents to request data include a summary of the research plan, request form, and institutional review board (IRB) review. Dataset will be shared after careful examination by the study board of investigators.

Locations

FR (1)