Airway ObstructionPhase 2NCT00548483
Comparison of High Dose and Low Dose Dexamethasone in Preventing Post-Extubation Airway Obstruction in Adults
A Phase 2 study testing dexamethasone (Oradexon, Nederland) in people with Airway Obstruction, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
The specific objectives were to determine whether high dose dexamethasone are more effective than low dose dexamethasone in the reduction or prevention of post-extubation airway obstruction among patients with a cuff leak volume (CLV) < 110 mL. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Airway Obstruction
- What is being tested?
- dexamethasone (Oradexon, Nederland)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2007to May 2008
- Phase
- Phase 2
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients were > 18 years of age and met the following weaning criteria:
- Temperature ≤ 38°C for > 8 hours,
- Discontinuous use of sedatives,
- Heart rate ≥ 70 and ≤ 130 /min,
- Systolic blood pressure (SBP) ≥ 80 mm Hg in the absence of vasopressors,
- Fraction of inspired oxygen (FiO2) ≤ 0.6, PaO2 ≥ 60, and partial pressure of oxygen (PaO2)/FiO2 ratio > 200,
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- Positive end-expiratory pressure (PEEP) ≤ 5 cm H2O,
- Rapid and shallow ratio of frequency to tidal volume (f/VT ≤ 105),
- Minute ventilation ≤ 15 L/min, and
- pH ≥ 7.3. Supplemental oxygen was continued to maintain an oxygen saturation > 95% as measured by a pulse oximeter.
Who cannot join
- A history of extubation during the same hospitalization
- Administration of corticosteroids seven days prior to extubation.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
No. 92, SEC. 2, CHUNG SHAN N. RD, TAIPEI, TAIWAN.
Taipei, 104
Chao-Hsien Lee, MD, 886-2-23926589, L49428@ms2.mmh.org.tw
About this study
Official title: Phase 2 Study of Comparison of High Dose and Low Dose Dexamethasone in Preventing Post-Extubation Airway Obstruction in Adults
The specific objectives were to determine whether high dose dexamethasone are more effective than low dose dexamethasone in the reduction or prevention of post-extubation airway obstruction among patients with a cuff leak volume (CLV) < 110 mL.
Read the detailed description
Controversy currently exists regarding the effectiveness of prophylactic steroid therapy for patients considered at high risk for post-extubation stridor. Studies regarding the efficacy of prophylactic corticosteroids for intubated patients have yielded conflicting results due to differences in the number, dose, or type of corticosteroids administered.
Only a limited number of prospective trials involving adults and evaluating the benefits and the dose of corticosteroid therapy prior to extubation have been conducted.The present study was conducted to evaluate the effects of prophylactic dexamethasone therapy for a subset of high-risk patients who had been intubated for > 48 hours and who were undergoing their first elective extubation in an ICU setting.
- Conditions
- Airway Obstruction
- Being tested
- dexamethasone (Oradexon, Nederland)
- Keywords
- Endotracheal intubation, Laryngeal edema, Cuff-leak test, Corticosteroids, This study was to ascertain whether administration of dexamethasone to critically intubated patients prevent postextubation airway obstruction., This study was to compare high dose and low dose dexamethasone in preventing noninvasive ventilation or reintubation among critically ill intubated patients
- Medical subject headings
- Airway Obstruction, Laryngeal Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasone (Oradexon, Nederland)Drug
dexamethasone 5mg was administered every 6 hour for 1 day in group 1 and dexamethasone 10mg was administered every 6 hour for 1 day in group 2
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | dexamethasone 5mg was administered every 6 hour for 1 day Receives: Drug: dexamethasone (Oradexon, Nederland) |
| 2 | Active comparator | dexamethasone 10mg was administered every 6 hour for 1 day Receives: Drug: dexamethasone (Oradexon, Nederland) |
What is being measured
The primary outcome is the main question the study is designed to answer.
absolute cuff leak volumes and relative cuff leak volume to tidal volume(%)(measured CLV-baseline CLV) X 100/ tidal volume)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2007 (estimated)
- Study startApr 2007
- Primary completionMar 2008 (estimated)
- Study completionMay 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Airway ObstructionStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chao-Hsien Lee, MD, Principal investigator, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00548483
- Sponsor's protocol ID
- MMH-I-S-107
- Status last verified
- May 2008
- First submitted
- 23 Oct 2007
- Last updated
- 28 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee CH, Peng MJ, Wu CL. Dexamethasone to prevent postextubation airway obstruction in adults: a prospective, randomized, double-blind, placebo-controlled study. Crit Care. 2007;11(4):R72. doi: 10.1186/cc5957.
PubMed 17605780Cheng KC, Hou CC, Huang HC, Lin SC, Zhang H. Intravenous injection of methylprednisolone reduces the incidence of postextubation stridor in intensive care unit patients. Crit Care Med. 2006 May;34(5):1345-50. doi: 10.1097/01.CCM.0000214678.92134.BD.
PubMed 16540947Francois 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 28 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Comparison of High Dose and Low Dose Dexamethasone in Preventing Post-Extubation Airway Obstruction in Adults
- ClinicalTrials.gov ID
- NCT00548483
- Acronym / sponsor ID
- MMH-I-S-107
- Conditions
- Airway Obstruction
- Keywords
- Endotracheal intubation, Laryngeal edema, Cuff-leak test, Corticosteroids, This study was to ascertain whether administration of dexamethasone to critically intubated patients prevent postextubation airway obstruction., This study was to compare high dose and low dose dexamethasone in preventing noninvasive ventilation or reintubation among critically ill intubated patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Mar 2008 (estimated)
- Study completion
- May 2008 (estimated)
- First posted
- 24 Oct 2007 (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.
The specific objectives were to determine whether high dose dexamethasone are more effective than low dose dexamethasone in the reduction or prevention of post-extubation airway obstruction among patients with a cuff leak volume (CLV) < 110 mL.
Detailed description
Controversy currently exists regarding the effectiveness of prophylactic steroid therapy for patients considered at high risk for post-extubation stridor. Studies regarding the efficacy of prophylactic corticosteroids for intubated patients have yielded conflicting results due to differences in the number, dose, or type of corticosteroids administered.
Only a limited number of prospective trials involving adults and evaluating the benefits and the dose of corticosteroid therapy prior to extubation have been conducted.The present study was conducted to evaluate the effects of prophylactic dexamethasone therapy for a subset of high-risk patients who had been intubated for > 48 hours and who were undergoing their first elective extubation in an ICU setting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: dexamethasone (Oradexon, Nederland)dexamethasone 5mg was administered every 6 hour for 1 day |
| 2 | Active comparator | Drug: dexamethasone (Oradexon, Nederland)dexamethasone 10mg was administered every 6 hour for 1 day |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Temperature ≤ 38°C for > 8 hours,
- Discontinuous use of sedatives,
- Heart rate ≥ 70 and ≤ 130 /min,
- Systolic blood pressure (SBP) ≥ 80 mm Hg in the absence of vasopressors,
- Fraction of inspired oxygen (FiO2) ≤ 0.6, PaO2 ≥ 60, and partial pressure of oxygen (PaO2)/FiO2 ratio > 200,
Key exclusion criteria (2 listed)
- A history of extubation during the same hospitalization
- Administration of corticosteroids seven days prior to extubation.
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 |
|---|---|---|
| dexamethasone (Oradexon, Nederland)dexamethasone 5mg was administered every 6 hour for 1 day in group 1 and dexamethasone 10mg was administered every 6 hour for 1 day in group 2 | Drug | 1, 2 |
Primary outcome
absolute cuff leak volumes and relative cuff leak volume to tidal volume(%)(measured CLV-baseline CLV) X 100/ tidal volume)
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2008.
- Background: PubMed 17605780Lee CH, Peng MJ, Wu CL. Dexamethasone to prevent postextubation airway obstruction in adults: a prospective, randomized, double-blind, placebo-controlled study. Crit Care. 2007;11(4):R72. doi: 10.1186/cc5957.
- Background: PubMed 16540947Cheng KC, Hou CC, Huang HC, Lin SC, Zhang H. Intravenous injection of methylprednisolone reduces the incidence of postextubation stridor in intensive care unit patients. Crit Care Med. 2006 May;34(5):1345-50. doi: 10.1097/01.CCM.0000214678.92134.BD.
- Background: 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.
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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.
Chao-Hsien Lee, MD principal investigator
Mackay Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dexamethasone (Oradexon, Nederland) in people with Airway Obstruction, run by Mackay Memorial Hospital at 1 site in Taiwan.
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 10 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 28 May 2008. 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 Taiwan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chao-Hsien Lee, MD (+886-2-23926589, L49428@ms2.mmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
absolute cuff leak volumes and relative cuff leak volume to tidal volume(%)(measured CLV-baseline CLV) X 100/ tidal volume) (time frame: 48 hours). 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 NCT00548483, which also lists 3 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 28 May 2008.