Intubation ComplicationNCT00953433
Laryngeal Morbidity After Endotracheal Intubation - Endoflex-tube Versus Use of Stylet
A study testing Endoflex tube and Polyvinyl chloride endotracheal tube with a stylet in people with Intubation Complication and Anaesthesia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
This study is aimed at reducing the risk of hoarseness and damage to the vocal cords following general anaesthesia. Conventional endotracheal intubation with use of a stylet will be compared with the Endoflex tube. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation Complication, Anaesthesia
- What is being tested?
- Endoflex tube and Polyvinyl chloride endotracheal tube with a stylet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2010to Aug 2011
- 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
- Elective surgical patients who require an endotracheal tube during general anaesthesia.
- Informed consent.
- Legally competent.
- Be able to understand Danish and be able to read the given information in Danish.
Who cannot join
- Planned or former operation in or around the pharynx or the larynx.
- Cancer, infection or sequelae in or around the pharynx or the larynx.
- Use of a stomach tube before or during surgery.
- Suspected difficult intubation.
Trial locations and contacts
1 site in 1 country.
About this study
This study is aimed at reducing the risk of hoarseness and damage to the vocal cords following general anaesthesia. Conventional endotracheal intubation with use of a stylet will be compared with the Endoflex tube. A conventional stylet enforced endotracheal tube is dirigible because of the stiffness gained by the addition of a stylet. In high risk rapid sequence intubation settings the enhanced dirigibility can be crucial, which is why most anaesthesiologists choose to add the stylet in these situations. A new endotracheal tube with a dynamic dirigible end called the Endoflex tube might prove to be a good alternative to the conventional stylet enforced endotracheal tube.
Study hypothesis: The Endoflex tube will reduce the risk of hoarseness after intubation when compared to the conventional stylet enforced endotracheal tube under optimal intubation conditions.
- Conditions
- Intubation Complication, Anaesthesia
- Being tested
- Endoflex tube, Polyvinyl chloride endotracheal tube with a stylet
- Keywords
- Intratracheal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoflex tubeDevice
Size decided upon gender.
Polyvinyl chloride endotracheal tube with a styletDevice
Size decided upon gender.
| Study group | Role | What they receive |
|---|---|---|
| Endoflex tube | Experimental | Use of Endoflex tube for intubation. Receives: Device: Endoflex tube |
| Endotracheal tube with stylet | Active comparator | Use of conventional endotracheal tube with a stylet for intubation. Receives: Device: Polyvinyl chloride endotracheal tube with a stylet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative hoarseness
Measured: 1 hr postoperatively
Secondary outcomes (15)
Vocal cord sequelae
Measured: Preoperative - on average 12 hours before operation
Intubation conditions
Measured: During and after intubation - on average 5 minutes
Intubation difficulty scale
Measured: During and after intubation - on average 5 minutes
Voice Range Profile
Only for the subgroup of patients with persisting hoarseness
Measured: 72 hours postoperatively
Multi Dimensional Voice Profile
Measured: Preoperative - on average 12 hours before operation
Voice Handicap Index
Measured: Preoperative - on average 12 hours before operation
Voice Range Profile
Only for the subgroup of patients with persisting hoarseness
Measured: After 4 weeks
Vocal cord sequelae
Measured: Within 24 hr postoperatively
Vocal cord sequelae
Only for the subgroup of patients with persisting hoarseness
Measured: 72 hours postoperatively
Vocal cord sequelae
Only for the subgroup of patients with persisting hoarseness
Measured: After 4 weeks
Multi Dimensional Voice Profile
Measured: Within 24 hr postoperatively
Multi Dimensional Voice Profile
Only for the subgroup of patients with persisting hoarseness
Measured: 72 hours postoperatively
Multi Dimensional Voice Profile
Only for the subgroup of patients with persisting hoarseness
Measured: After 4 weeks
Voice Handicap Index
Only for the subgroup of patients with persisting hoarseness
Measured: After 4 weeks
Voice Handicap Index
Only for the subgroup of patients with persisting hoarseness
Measured: 72 hr postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startApr 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation ComplicationStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- TrygFonden, Denmark
- Responsible party
- Principal investigator, Martin Kryspin Soerensen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Lars Rasmussen, MD, PHD, Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00953433
- Sponsor's protocol ID
- Endoflex-Stylet
- Status last verified
- Aug 2011
- First submitted
- 5 Aug 2009
- Last updated
- 24 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laryngeal Morbidity After Endotracheal Intubation - Endoflex-tube Versus Use of Stylet
- ClinicalTrials.gov ID
- NCT00953433
- Acronym / sponsor ID
- Endoflex-Stylet
- Conditions
- Intubation Complication, Anaesthesia
- Keywords
- Intratracheal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- TrygFonden, Denmark
- Study start
- Apr 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 6 Aug 2009 (estimated)
- 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.
This study is aimed at reducing the risk of hoarseness and damage to the vocal cords following general anaesthesia. Conventional endotracheal intubation with use of a stylet will be compared with the Endoflex tube. A conventional stylet enforced endotracheal tube is dirigible because of the stiffness gained by the addition of a stylet. In high risk rapid sequence intubation settings the enhanced dirigibility can be crucial, which is why most anaesthesiologists choose to add the stylet in these situations. A new endotracheal tube with a dynamic dirigible end called the Endoflex tube might prove to be a good alternative to the conventional stylet enforced endotracheal tube.
Study hypothesis: The Endoflex tube will reduce the risk of hoarseness after intubation when compared to the conventional stylet enforced endotracheal tube under optimal intubation conditions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoflex tube | Experimental | Device: Endoflex tubeUse of Endoflex tube for intubation. |
| Endotracheal tube with stylet | Active comparator | Device: Polyvinyl chloride endotracheal tube with a styletUse of conventional endotracheal tube with a stylet for intubation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elective surgical patients who require an endotracheal tube during general anaesthesia.
- Informed consent.
- Legally competent.
- Be able to understand Danish and be able to read the given information in Danish.
Key exclusion criteria (4 listed)
- Planned or former operation in or around the pharynx or the larynx.
- Cancer, infection or sequelae in or around the pharynx or the larynx.
- Use of a stomach tube before or during surgery.
- Suspected difficult intubation.
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 |
|---|---|---|
| Endoflex tubeSize decided upon gender. | Device | Endoflex tube |
| Polyvinyl chloride endotracheal tube with a styletSize decided upon gender. | Device | Endotracheal tube with stylet |
Primary outcome
Postoperative hoarseness
Time frame: 1 hr postoperatively
15 secondary outcomes
Vocal cord sequelae
Time frame: Preoperative - on average 12 hours before operation
Intubation conditions
Time frame: During and after intubation - on average 5 minutes
Intubation difficulty scale
Time frame: During and after intubation - on average 5 minutes
Voice Range Profile
Time frame: 72 hours postoperatively
Multi Dimensional Voice Profile
Time frame: Preoperative - on average 12 hours before operation
Voice Handicap Index
Time frame: Preoperative - on average 12 hours before operation
Voice Range Profile
Time frame: After 4 weeks
Vocal cord sequelae
Time frame: Within 24 hr postoperatively
Vocal cord sequelae
Time frame: 72 hours postoperatively
Vocal cord sequelae
Time frame: After 4 weeks
Multi Dimensional Voice Profile
Time frame: Within 24 hr postoperatively
Multi Dimensional Voice Profile
Time frame: 72 hours postoperatively
Multi Dimensional Voice Profile
Time frame: After 4 weeks
Voice Handicap Index
Time frame: After 4 weeks
Voice Handicap Index
Time frame: 72 hr postoperatively
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 24 Aug 2011.
Related trials for Intubation Complication
Recruiting
Smart Checklist Implementation for Pediatric Tracheal Intubations in the ICU- Multicenter Study
Intubation Complication
Recruiting
The ED-AWARENESS-2 Trial
Awareness, Mechanical Ventilation
RecruitingObservational study
Cardiovascular History and Hemodynamic Complications After Intubation in ICU
Hemodynamic Complications
Not yet recruiting
Postoperative Pulmonary Complications After Use of Supraglottic Airway Devices and Neuromuscular Blockade
Postoperative Pulmonary Complications
Not yet recruiting
Establish Whether Hyperangulated Videolaryngoscopy (HAVL) Can be Used to Facilitate Tracheal Intubation Effectively and Safely in Unselected Adult Patients; Describe the Population in Whom HAVL Fails to Facilitate Tracheal Intubation Successfully, Identifying Any Contributory Characteristics.
Intubation Skill, Intubation Complications
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.
Lars Rasmussen, MD, PHD study chair
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoflex tube and Polyvinyl chloride endotracheal tube with a stylet in people with Intubation Complication and Anaesthesia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 4 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 24 Aug 2011. 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 Denmark. 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?
Postoperative hoarseness (time frame: 1 hr postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2011.