Intubation ComplicationSTYLETONCT04079387
Effect of Endotracheal Tube Plus STYLET Versus Endotracheal Tube Alone
A study testing ENDOTRACHEAL TUBE + STYLET and ENDOTRACHEAL TUBE ALONE in people with Intubation Complication and Critically Ill, run by University Hospital, Montpellier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation Complication, Critically Ill
- What is being tested?
- ENDOTRACHEAL TUBE + STYLET and ENDOTRACHEAL TUBE ALONE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,040 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2019to 15 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Universitaire Montpellier, Saint Eloi
Montpellier, Languedoc-Roussillon, 34295
About this study
Official title: 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"
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
Read the 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.
- Conditions
- Intubation Complication, Critically Ill
- Being tested
- ENDOTRACHEAL TUBE + STYLET, ENDOTRACHEAL TUBE ALONE
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENDOTRACHEAL TUBE + STYLETDevice
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 ALONEDevice
intubating the trachea with an endotracheal tube alone
| Study group | Role | What they receive |
|---|---|---|
| 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°. Receives: 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). Receives: Device: ENDOTRACHEAL TUBE ALONE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with successful first-pass orotracheal intubation
the proportion of patients with successful first-pass orotracheal intubation
Measured: At intubation
Secondary outcomes (1)
Complications related to 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
Measured: 1 hour after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start1 Oct 2019
- Primary completion17 Mar 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intubation ComplicationStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,040 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04079387
- Sponsor's protocol ID
- RECHMPL19_0216
- Acronym
- STYLETO
- Status last verified
- May 2026
- First submitted
- 29 Aug 2019
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 34032882Jaber 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.
PubMed 33033014
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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"
- ClinicalTrials.gov ID
- NCT04079387
- Acronym / sponsor ID
- STYLETO / RECHMPL19_0216
- Conditions
- Intubation Complication, Critically Ill
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,040 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 17 Mar 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ENDOTRACHEAL TUBE + STYLET | Experimental | Device: ENDOTRACHEAL TUBE + STYLETThe 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 ALONE | Active comparator | Device: ENDOTRACHEAL TUBE ALONEThe control group consists in intubating the trachea with an endotracheal tube alone (i.e, without stylet). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENDOTRACHEAL TUBE + STYLETThe 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 ALONEintubating the trachea with an endotracheal tube alone | Device | ENDOTRACHEAL TUBE ALONE |
Primary outcome
Number of patients with successful first-pass orotracheal intubation
Time frame: At intubation
the proportion of patients with successful first-pass orotracheal intubation
1 secondary outcome
Complications related to intubation
Time frame: 1 hour after intubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Results publication: PubMed 34032882Jaber 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.
- Derived from this study: PubMed 33033014Jaber 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENDOTRACHEAL TUBE + STYLET and ENDOTRACHEAL TUBE ALONE in people with Intubation Complication and Critically Ill, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with successful first-pass orotracheal intubation (time frame: At intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04079387, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.