Back to results

Comparison of High Dose and Low Dose Dexamethasone in Preventing Post-Extubation Airway Obstruction in Adults

Primary Purpose

Airway Obstruction

Status

Unknown status

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

dexamethasone (Oradexon, Nederland)

About this trial

This is an interventional prevention trial for Airway Obstruction focused on measuring 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

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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,
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.

Exclusion Criteria:

A history of extubation during the same hospitalization
Administration of corticosteroids seven days prior to extubation.

Sites / Locations

No. 92, SEC. 2, CHUNG SHAN N. RD, TAIPEI, TAIWAN.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

dexamethasone 5mg was administered every 6 hour for 1 day

dexamethasone 10mg was administered every 6 hour for 1 day

Outcomes

Primary Outcome Measures

absolute cuff leak volumes and relative cuff leak volume to tidal volume(%)(measured CLV-baseline CLV) X 100/ tidal volume)

Secondary Outcome Measures

Full Information

NCT ID

NCT00548483

First Posted

October 23, 2007

Last Updated

May 27, 2008

Sponsor

Mackay Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00548483

Brief Title

Comparison of High Dose and Low Dose Dexamethasone in Preventing Post-Extubation Airway Obstruction in Adults

Official Title

Phase 2 Study of Comparison of High Dose and Low Dose Dexamethasone in Preventing Post-Extubation Airway Obstruction in Adults

Study Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Unknown status

Study Start Date

April 2007 (undefined)

Primary Completion Date

March 2008 (Anticipated)

Study Completion Date

May 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Mackay Memorial Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

dexamethasone 5mg was administered every 6 hour for 1 day

Arm Title

Arm Type

Active Comparator

Arm Description

dexamethasone 10mg was administered every 6 hour for 1 day

Intervention Type

Drug

Intervention Name(s)

dexamethasone (Oradexon, Nederland)

Intervention Description

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

Primary Outcome Measure Information:

Title

absolute cuff leak volumes and relative cuff leak volume to tidal volume(%)(measured CLV-baseline CLV) X 100/ tidal volume)

Time Frame

48 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

95 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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, 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. Exclusion Criteria: A history of extubation during the same hospitalization Administration of corticosteroids seven days prior to extubation.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chao-Hsien Lee, MD

Phone

+886-2-23926589

L49428@ms2.mmh.org.tw

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chao-Hsien Lee, MD

Organizational Affiliation

Mackay Memorial Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

No. 92, SEC. 2, CHUNG SHAN N. RD, TAIPEI, TAIWAN.

City

Taipei

ZIP/Postal Code

104

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chao-Hsien Lee, MD

Phone

886-2-23926589

L49428@ms2.mmh.org.tw

12. IPD Sharing Statement

Citations:

PubMed Identifier

17605780

Citation

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.

Results Reference

background

PubMed Identifier

16540947

Citation

Cheng 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. Erratum In: Crit Care Med. 2007 May;35(5):1454.

Results Reference

background

PubMed Identifier

17398307

Citation

Francois 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.

Results Reference

background

Learn more about this trial

Comparison of High Dose and Low Dose Dexamethasone in Preventing Post-Extubation Airway Obstruction in Adults

We'll reach out to this number within 24 hrs