Post-Extubation Laryngeal EdemaPhase 3NCT00199576
Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids
A Phase 3 study testing Methylprednisolone in people with Post-Extubation Laryngeal Edema, run by University Hospital, Limoges at 15 sites in France.
Trial summary
Tracheal intubation is a frequent procedure in intensive care units (ICU). Post-extubation laryngeal edema is a frequent complication with potential morbidity and mortality, and may lead to urgent tracheal re-intubation. Corticosteroids have been proposed to reduce the incidence of post-extubation laryngeal edema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Extubation Laryngeal Edema
- What is being tested?
- Methylprednisolone
- How many people
- 670 participants
- Where
- 15 sitesFrance
- Study dates
- Dec 2000to Jan 2002
- Phase
- Phase 3
- 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
- Adult ≥ 18 years
- Intubated for ≥ 36 hours
- Scheduled extubation
- Informed written consent
Who cannot join
- pregnancy
- history of postextubation laryngeal dyspnea
- laryngeal disease
- tracheotomy
- patient receiving corticotherapy prior to admission
- traumatic intubation
- participation to this study or to another trial
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
Réanimation médicale et chirurgicale - Hôpital d'Angoulême
Angoulême
Service de Réanimation - CH de Brive
Brivé
Service de Réanimation - CH de Chartres
Chartres
Service de Réanimation - CH de Chateauroux
Châteauroux
Réanimation polyvalente - Hôpital de Cholet
Cholet
Service de Réanimation - CH de Dreux
Dreux
Service de Réanimation - CH de Le Mans
Le Mans
Service de Réanimation Polyvalente - Hôpital Dupuytren
Limoges, 87042
Réanimation polyvalente - Hôpital d'Orléans
Orléans
Service Réanimation - CH de Poitiers
Poitiers
Service de Réanimation - CH de Saint Nazaire
Saint-Nazaire
Service de Réanimation - CH de Saintes
Saintes
Service de Réanimation - CH Saint Malo
St-Malo
Réanimation Médicale - Hôpital Bretonneau
Tours
Service de Réanimation - CH de Vannes
Vannes
About this study
Official title: Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids: a Prospective, Double-Blind, Placebo-Controlled Trial.
Tracheal intubation is a frequent procedure in intensive care units (ICU). Post-extubation laryngeal edema is a frequent complication with potential morbidity and mortality, and may lead to urgent tracheal re-intubation. Corticosteroids have been proposed to reduce the incidence of post-extubation laryngeal edema. A few clinical studies have been conducted in adult ICU patients and have led to discrepant results. These discrepancies may be related to the time lag separating the administration of the corticosteroids and the planned extubation. Accordingly, we tested the hypothesis that pretreatment with corticosteroids initiated 12 hours before a planned extubation may efficiently prevent the occurrence of postextubation laryngeal edema in critically-ill adults who have been mechanically ventilated for more than 36 hours in the ICU.
Read the detailed description
We conducted a prospective, double-blind, placebo-controlled, multicenter trial of 12-hour-pretreatment by methylprednisolone before a planned extubation in adult patients ventilated for more than 36 hours in the ICU. Methylprednisolone (20 mg) or placebo was first administered intravenously 12 hours before extubation and continued every 4 hours until tube removal. Primary endpoint was the occurrence of laryngeal edema within 24 hours of extubation. Laryngeal edema was clinically diagnosed and considered as major when requiring tracheal reintubation.
- Conditions
- Post-Extubation Laryngeal Edema
- Being tested
- Methylprednisolone
- Keywords
- Corticosteroids, Laryngotracheal injury, Intubation-extubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of a laryngeal edema within 24 hours after a planned tracheal extubation
Secondary outcomes (3)
- Severity of laryngeal edema (minor or major)
- Time to onset of edema (in minutes) after tracheal extubation
- Need for a tracheal re-intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startDec 2000
- Study completionJan 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post-Extubation Laryngeal EdemaStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 670 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Investigators
- Eric Bellissant, MD, PhD, Study chair, Rennes University HospitalBruno Francois, MD, Principal investigator, CH Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199576
- Sponsor's protocol ID
- AFSSAPS 001533
- Other IDs
- CIC0203/023
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 20 Sep 2005
- Results posted
- No
Publications
Kastanos N, Estopa Miro R, Marin Perez A, Xaubet Mir A, Agusti-Vidal A. Laryngotracheal injury due to endotracheal intubation: incidence, evolution, and predisposing factors. A prospective long-term study. Crit Care Med. 1983 May;11(5):362-7. doi: 10.1097/00003246-198305000-00009.
PubMed 6839788Darmon JY, Rauss A, Dreyfuss D, Bleichner G, Elkharrat D, Schlemmer B, Tenaillon A, Brun-Buisson C, Huet Y. Evaluation of risk factors for laryngeal edema after tracheal extubation in adults and its prevention by dexamethasone. A placebo-controlled, double-blind, multicenter study. Anesthesiology. 1992 Aug;77(2):245-51. doi: 10.1097/00000542-199208000-00004.
PubMed 1642342Ho LI, Harn HJ, Lien TC, Hu PY, Wang JH. Postextubation laryngeal edema in adults. Risk factor evaluation and prevention by hydrocortisone. Intensive Care Med. 1996 Sep;22(9):933-6. doi: 10.1007/BF02044118.
PubMed 8905428Francois B, Bellissant E, Gissot V, Desachy A, Normand S, Boulain T, Brenet O, Preux PM, Vignon P; Association des Reanimateurs du Centre-Ouest (ARCO). 12-h pretreatment with methylprednisolone versus placebo for prevention of postextubation laryngeal oedema: a randomised double-blind trial. Lancet. 2007 Mar 31;369(9567):1083-9. doi: 10.1016/S0140-6736(07)60526-1.
PubMed 17398307
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids: a Prospective, Double-Blind, Placebo-Controlled Trial.
- ClinicalTrials.gov ID
- NCT00199576
- Acronym / sponsor ID
- AFSSAPS 001533
- Conditions
- Post-Extubation Laryngeal Edema
- Keywords
- Corticosteroids, Laryngotracheal injury, Intubation-extubation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 670 participants
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Dec 2000
- Study completion
- Jan 2002
- First posted
- 20 Sep 2005 (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.
Tracheal intubation is a frequent procedure in intensive care units (ICU). Post-extubation laryngeal edema is a frequent complication with potential morbidity and mortality, and may lead to urgent tracheal re-intubation. Corticosteroids have been proposed to reduce the incidence of post-extubation laryngeal edema. A few clinical studies have been conducted in adult ICU patients and have led to discrepant results. These discrepancies may be related to the time lag separating the administration of the corticosteroids and the planned extubation. Accordingly, we tested the hypothesis that pretreatment with corticosteroids initiated 12 hours before a planned extubation may efficiently prevent the occurrence of postextubation laryngeal edema in critically-ill adults who have been mechanically ventilated for more than 36 hours in the ICU.
Detailed description
We conducted a prospective, double-blind, placebo-controlled, multicenter trial of 12-hour-pretreatment by methylprednisolone before a planned extubation in adult patients ventilated for more than 36 hours in the ICU. Methylprednisolone (20 mg) or placebo was first administered intravenously 12 hours before extubation and continued every 4 hours until tube removal. Primary endpoint was the occurrence of laryngeal edema within 24 hours of extubation. Laryngeal edema was clinically diagnosed and considered as major when requiring tracheal reintubation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult ≥ 18 years
- Intubated for ≥ 36 hours
- Scheduled extubation
- Informed written consent
Key exclusion criteria (7 listed)
- pregnancy
- history of postextubation laryngeal dyspnea
- laryngeal disease
- tracheotomy
- patient receiving corticotherapy prior to admission
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 |
|---|---|---|
| Methylprednisolone | Drug | – |
Primary outcome
Onset of a laryngeal edema within 24 hours after a planned tracheal extubation
3 secondary outcomes
- Severity of laryngeal edema (minor or major)
- Time to onset of edema (in minutes) after tracheal extubation
- Need for a tracheal re-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 20 Sep 2005.
- Background: PubMed 6839788Kastanos N, Estopa Miro R, Marin Perez A, Xaubet Mir A, Agusti-Vidal A. Laryngotracheal injury due to endotracheal intubation: incidence, evolution, and predisposing factors. A prospective long-term study. Crit Care Med. 1983 May;11(5):362-7. doi: 10.1097/00003246-198305000-00009.
- Background: PubMed 1642342Darmon JY, Rauss A, Dreyfuss D, Bleichner G, Elkharrat D, Schlemmer B, Tenaillon A, Brun-Buisson C, Huet Y. Evaluation of risk factors for laryngeal edema after tracheal extubation in adults and its prevention by dexamethasone. A placebo-controlled, double-blind, multicenter study. Anesthesiology. 1992 Aug;77(2):245-51. doi: 10.1097/00000542-199208000-00004.
- Background: PubMed 8905428Ho LI, Harn HJ, Lien TC, Hu PY, Wang JH. Postextubation laryngeal edema in adults. Risk factor evaluation and prevention by hydrocortisone. Intensive Care Med. 1996 Sep;22(9):933-6. doi: 10.1007/BF02044118.
- Derived from this study: PubMed 17398307Francois B, Bellissant E, Gissot V, Desachy A, Normand S, Boulain T, Brenet O, Preux PM, Vignon P; Association des Reanimateurs du Centre-Ouest (ARCO). 12-h pretreatment with methylprednisolone versus placebo for prevention of postextubation laryngeal oedema: a randomised double-blind trial. Lancet. 2007 Mar 31;369(9567):1083-9. doi: 10.1016/S0140-6736(07)60526-1.
Related trials for Post-Extubation Laryngeal Edema
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Corticosteroids for Post-Extubation Dysphagia
Dysphagia, Laryngeal Edema
Recruiting
Predicting Post Extubation Stridor After Maxillomandibular Fixation
Stridor, Larynx Edema
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.
Eric Bellissant, MD, PhD study chair
Rennes University Hospital
Bruno Francois, MD principal investigator
CH Limoges
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methylprednisolone in people with Post-Extubation Laryngeal Edema, run by University Hospital, Limoges at 15 sites 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 7 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 20 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Onset of a laryngeal edema within 24 hours after a planned tracheal extubation. 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 NCT00199576, which also lists 4 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 20 Sep 2005.