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Effect of Endotracheal Tube Plus STYLET Versus Endotracheal Tube Alone (STYLETO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04079387
Recruitment Status : Completed
First Posted : September 6, 2019
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Tracking Information
First Submitted Date  ICMJE August 29, 2019
First Posted Date  ICMJE September 6, 2019
Last Update Posted Date November 13, 2020
Actual Study Start Date  ICMJE October 1, 2019
Actual Primary Completion Date June 16, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2019)
Number of patients with successful first-pass orotracheal intubation [ Time Frame: At intubation ]
the proportion of patients with successful first-pass orotracheal intubation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2019)
Complications related to intubation [ Time Frame: 1 hour after intubation ]
severe hypoxemia defined by lowest oxygen saturation (SpO2) < 80 %, severe cardiovascular collapse, defined as systolic blood pressure less than 65 mm Hg recorded at least once or less than 90 mm Hg lasting 30 minutes despite 500-1,000 ml of fluid loading (crystalloids solutions) or requiring introduction or increasing doses by more than 30% of vasoactive support, cardiac arrest, death during intubation; moderate: difficult intubation, severe ventricular or supraventricular arrhythmia requiring intervention, oesophageal intubation, agitation, pulmonary aspiration, dental injuries
Original Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2019)
Complications related to intubation [ Time Frame: 1 hour after intubation ]
severe hypoxemia defined by lowest saturation < 80 %, severe cardiovascular collapse, defined as systolic blood pressure less than 65 mm Hg recorded at least once or less than 90 mm Hg lasting 30 minutes despite 500-1,000 ml of fluid loading (crystalloids solutions) or requiring introduction or increasing doses by more than 30% of vasoactive support, cardiac arrest, death during intubation; moderate: difficult intubation, severe ventricular or supraventricular arrhythmia requiring intervention, oesophageal intubation, agitation, pulmonary aspiration, dental injuries
Current Other Pre-specified Outcome Measures
 (submitted: February 27, 2020)
  • Lowest SpO2 up to 24 hours after intubation [ Time Frame: up to 24 hours after intubation ]
    Assessment of the value of the lowest SpO2
  • Highest positive end expiratory pressure (PEEP) up to 24 hours after intubation [ Time Frame: up to 24 hours after intubation ]
    Assessment of the value of the highest PEEP
  • Highest fraction of inspired oxygen (FiO2) up to 24 hours after intubation [ Time Frame: up to 24 hours after intubation ]
    Assessment of the value of the highest FiO2
  • lowest SpO2 < 90% [ Time Frame: during intubation ]
    incidence of lowest SpO2 less than 90% from induction to 2 minutes after intubation
  • Change in SpO2 [ Time Frame: during intubation ]
    Change in SpO2 from SpO2 at induction to lowest SpO2
  • desaturation [ Time Frame: during intubation ]
    desaturation, defined as a change in SpO2 of more than 3% from induction to 2 minutes after intubation
  • Cormack Lehane [ Time Frame: during intubation ]
    Cormack-Lehane grade of glottic view
  • difficulty of intubation [ Time Frame: during intubation ]
    operator-assessed difficulty of intubation
  • additional airway equipment or second operator [ Time Frame: during intubation ]
    need for additional airway equipment or a second operator
  • laryngoscopy attempts [ Time Frame: during intubation ]
    number of laryngoscopy attempts
  • Lowest SpO2 from 0-1 hour post intubation [ Time Frame: up to 1 hour after intubation ]
    Assessment of the value of the lowest SpO2 from 0-1 hours after intubation
  • Highest FiO2 from 0-1 hour post intubation [ Time Frame: up to 1 hour after intubation ]
    Assessment of the value of the highest FiO2 from 0-1 hours after intubation
  • Highest PEEP from 0-1 hour post intubation [ Time Frame: up to 1 hour after intubation ]
    Assessment of the value of the highest PEEP from 0-1 hours after intubation
  • Lowest SpO2 from 1-6 hours post intubation [ Time Frame: From 1 to 6 hours after intubation ]
    Assessment of the value of the lowest SpO2 from 1-6 hours after intubation
  • Highest FiO2 from 1-6 hours post intubation [ Time Frame: From 1 to 6 hours after intubation ]
    Assessment of the value of the highest FiO2 from 1-6 hours after intubation
  • Highest PEEP from 1-6 hours post intubation [ Time Frame: From 1 to 6 hours after intubation ]
    Assessment of the value of the highest PEEP from 1-6 hours after intubation
  • new infiltrate [ Time Frame: Up to 48 hours after intubation ]
    new infiltrate on chest imaging in the 48 hours after intubation
  • new pneumothorax [ Time Frame: Up to 24 hours after intubation ]
    new pneumothorax on chest imaging in the 24 hours after intubation
  • new pneumomediastinum [ Time Frame: Up to 24 hours after intubation ]
    new pneumomediastinum on chest imaging in the 24 hours after intubation
  • Intensive care unit (ICU) length of stay [ Time Frame: Up to 90 days after intubation ]
    ICU length of stay
  • ICU-free days [ Time Frame: Up to 90 days after intubation ]
    ICU-free days
  • invasive ventilator-free days [ Time Frame: Up to 90 days after intubation ]
    invasive ventilator-free days
  • mortality rate on day 28 [ Time Frame: Up to 28 days after intubation ]
    mortality rate on day 28
  • In hospital mortality [ Time Frame: Up to 90 days after intubation ]
    in hospital mortality
  • mortality rate on day 90 [ Time Frame: Up to 90 days after intubation ]
    mortality rate on day 90
Original Other Pre-specified Outcome Measures
 (submitted: September 3, 2019)
  • Lowest SpO2 up to 24 hours after intubation [ Time Frame: up to 24 hours after intubation ]
    Assessment of the value of the lowest SpO2
  • Highest PEEP up to 24 hours after intubation [ Time Frame: up to 24 hours after intubation ]
    Assessment of the value of the highest PEEP
  • Highest FiO2 up to 24 hours after intubation [ Time Frame: up to 24 hours after intubation ]
    Assessment of the value of the highest FiO2
  • lowest oxygen saturation < 90% [ Time Frame: during intubation ]
    incidence of lowest oxygen saturation less than 90% from induction to 2 minutes after intubation
  • Change in saturation [ Time Frame: during intubation ]
    Change in saturation from oxygen saturation at induction to lowest oxygen saturation
  • desaturation [ Time Frame: during intubation ]
    desaturation, defined as a change in oxygen saturation of more than 3% from induction to 2 minutes after intubation
  • Cormack Lehane [ Time Frame: during intubation ]
    Cormack-Lehane grade of glottic view
  • difficulty of intubation [ Time Frame: during intubation ]
    operator-assessed difficulty of intubation
  • additional airway equipment or second operator [ Time Frame: during intubation ]
    need for additional airway equipment or a second operator
  • laryngoscopy attempts [ Time Frame: during intubation ]
    number of laryngoscopy attempts
  • Lowest SpO2 from 0-1 hour post intubation [ Time Frame: up to 1 hour after intubation ]
    Assessment of the value of the lowest SpO2 from 0-1 hours after intubation
  • Highest FiO2 from 0-1 hour post intubation [ Time Frame: up to 1 hour after intubation ]
    Assessment of the value of the highest FiO2 from 0-1 hours after intubation
  • Highest PEEP from 0-1 hour post intubation [ Time Frame: up to 1 hour after intubation ]
    Assessment of the value of the highest PEEP from 0-1 hours after intubation
  • Lowest SpO2 from 1-6 hours post intubation [ Time Frame: From 1 to 6 hours after intubation ]
    Assessment of the value of the lowest SpO2 from 1-6 hours after intubation
  • Highest FiO2 from 1-6 hours post intubation [ Time Frame: From 1 to 6 hours after intubation ]
    Assessment of the value of the highest FiO2 from 1-6 hours after intubation
  • Highest PEEP from 1-6 hours post intubation [ Time Frame: From 1 to 6 hours after intubation ]
    Assessment of the value of the highest PEEP from 1-6 hours after intubation
  • new infiltrate [ Time Frame: Up to 48 hours after intubation ]
    new infiltrate on chest imaging in the 48 hours after intubation
  • new pneumothorax [ Time Frame: Up to 24 hours after intubation ]
    new pneumothorax on chest imaging in the 24 hours after intubation
  • new pneumomediastinum [ Time Frame: Up to 24 hours after intubation ]
    new pneumomediastinum on chest imaging in the 24 hours after intubation
  • ICU length of stay [ Time Frame: Up to 90 days after intubation ]
    ICU length of stay
  • ICU-free days [ Time Frame: Up to 90 days after intubation ]
    ICU-free days
  • invasive ventilator-free days [ Time Frame: Up to 90 days after intubation ]
    invasive ventilator-free days
  • mortality rate on day 28 [ Time Frame: Up to 90 days after intubation ]
    mortality rate on day 28
  • In hospital mortality [ Time Frame: Up to 90 days after intubation ]
    in hospital mortality (or day 90 if the patient is still in hospital)
 
Descriptive Information
Brief Title  ICMJE Effect of Endotracheal Tube Plus STYLET Versus Endotracheal Tube Alone
Official Title  ICMJE Effect of Endotracheal Tube Plus STYLET Versus Endotracheal Tube Alone on Successful First-Pass Orotracheal Intubation Among Critically Ill Patients: the Randomised STYLETO Study Protocol"
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

Detailed Description

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.Severe hypoxaemia occurring during intubation procedure can result in cardiac arrest,cerebral anoxia, and death.Difficult intubation is known to be associated with life-threatening complications both in operating room and in emergent conditions.ICU intubation conditions are worse than intubation conditions in operative rooms.A non-planned and urgent intubation procedure, severity of patient disease and ergonomic issues explain the morbidity associated with intubation in ICU.To prevent and limit the incidence of severe hypoxemia following intubation and its complications, several intubation algorithms have been developed ,and specific risk factors for difficult intubation in ICU have been identified.

In 2018, a large multicenter study reported first-attempt intubation success rates using direct laryngoscopy of 70% and videolaryngoscopy of 67%. In 2019, a multicentre randomized trial,assessing whether positive-pressure ventilation with a bag-mask device (bag-mask ventilation) during tracheal intubation of critically ill adults prevents hypoxemia, reported a first-attempt success rate of 81%. Other authors reported an overall first-attempt intubation success rate of 74%. The 20% to 40% first-attempt failure rates throughout studies highlight the opportunity to improve the safety and efficiency of this critical procedure. 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.

However, some complications from intubating stylets have been reported including mucosal bleeding, perforation of the trachea or esophagus, and sore throat. In 2018, one study has assessed the effect of adding a stylet in case of difficult intubation in prehospital setting.However, in ICU, the systematic use of a stylet is still debated and recent recommendations do not recommend to use or not to use such devices for first-pass intubation. The device chosen for intubation may therefore be a confounding factor between the relation of stylet use and first-attempt success.The routine use of a stylet for first-pass intubation using laryngoscopes in ICU has never been assessed and benefit remains to be established.

The investigators hypothesis that adding stylet to endotracheal tube will increase the frequency of successful first-pass intubation compared with use endotracheal tube alone (i.e, without stylet) in ICU patients needing mechanical ventilation.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Intubation Complication
  • Critically Ill
Intervention  ICMJE
  • Device: ENDOTRACHEAL TUBE + STYLET
    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 ALONE
    intubating the trachea with an endotracheal tube alone
Study Arms  ICMJE
  • Experimental: ENDOTRACHEAL TUBE + STYLET
    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°.
    Intervention: Device: ENDOTRACHEAL TUBE + STYLET
  • Active Comparator: ENDOTRACHEAL TUBE ALONE
    The control group consists in intubating the trachea with an endotracheal tube alone (i.e, without stylet).
    Intervention: Device: ENDOTRACHEAL TUBE ALONE
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 3, 2019)
1040
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 10, 2020
Actual Primary Completion Date June 16, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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
  • Written informed consent from the patient or proxy (if present) before inclusion or once possible when patient has been included in a context of emergency.

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04079387
Other Study ID Numbers  ICMJE 7803
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: 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.
Responsible Party University Hospital, Montpellier
Study Sponsor  ICMJE University Hospital, Montpellier
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Montpellier
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP