Effectiveness of Steroids vs Placebo in Preventing Upper Airway Obstruction After Extubation in Critically-Ill Children: Rationale and Design of a Multicentric, Double-Blind, Randomized Study

Abstract Background: Post-extubation upper airway obstruction (UAO) is a frequent complication causing stridor and respiratory distress, which occasionally may require reintubation, thereby increasing morbidity and mortality rates. Contradictory results have been obtained in studies assessing the effectiveness of steroids in preventing post-extubation UAO, and the available evidence is limited. We designed a multicentric randomized, placebo-controlled study to explore the effectiveness of dexamethasone in preventing post-extubation UAO in children. Methods: A multicentric, prospective, double-blind, randomized, placebo-controlled, phase IV clinical trial has been designed. The sample will include pediatric patients between 1 month and 16 years of age who have been intubated for more than 48 hours. Patients with airway disorders or who have received steroids within the last seven days will be excluded. Patients will be randomized to receive either placebo or a therapy with dexamethasone 0.25 mg/kg every 6 hours to be started 6-to-12 hours prior to extubation, to a total of four doses. Randomization will be performed at a 1:1 ratio. Follow-up of patients will be carried out for 48 h after extubation. The main objective of this study is to access the reduction in the incidence of moderate-severe UAO symptoms following extubation. Secondary objectives include assessing the decrease in the incidence of reintubation, evaluating the use of additional therapies for upper airway obstruction, and monitoring dexamethasone potential side effects. Discussion: The results of this study will contribute to the existing evidence on prophylaxis for post-extubation airway obstruction. Trial registration: EudraCT identifier, 2009-016596-30. Registered on 11 May 2010.

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Effectiveness of steroids vs placebo in preventing upper airway obstruction after extubation in critically-ill children: rationale and design of a multicentric, double-blind, randomized study.

10.21203/rs.2.12891/v2 ◽

2019 ◽

Author(s):

Gema Manrique ◽

Laura Butragueño Laiseca ◽

Rafael González ◽

Corsino Rey ◽

Zuriñe Martínez ◽

...

Keyword(s):

Airway Obstruction ◽

Pediatric Patients ◽

Randomized Study ◽

Upper Airway ◽

Upper Airway Obstruction ◽

Critically Ill Children ◽

Controlled Study ◽

Double Blind ◽

To Receive

Abstract Background Post-extubation upper airway obstruction (UAO) is a frequent complication causing stridor and respiratory distress, which occasionally may require reintubation, thereby increasing morbidity and mortality rates. Contradictory results have been obtained in studies assessing the effectiveness of steroids in preventing post-extubation UAO, and the available evidence is limited. We designed a multicentric randomized, placebo-controlled study to explore the effectiveness of dexamethasone in preventing post-extubation UAO in children. Methods A multicentric, prospective, double-blind, randomized, placebo-controlled, phase IV clinical trial has been designed. The sample will include pediatric patients between 1 month and 16 years of age who have been intubated for more than 48 hours. Patients with airway disorders or who have received steroids within the last seven days will be excluded. Patients will be randomized to receive either placebo or a therapy with dexamethasone 0.25 mg/kg every 6 hours to be started 6-to-12 hours prior to extubation, to a total of four doses. Randomization will be performed at a 1:1 ratio. Follow-up of patients will be carried out for 48 h after extubation. The main objective of this study is to assess the reduction of UAO symptoms following extubation, as measured using the Taussig scale. Secondary objectives include assessing the decrease in the incidence of reintubation, evaluating the use of additional therapies for upper airway obstruction, and monitoring dexamethasone potential side effects. Discussion The results of this study will contribute to the existing evidence on prophylaxis for post-extubation airway obstruction.

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EFFECTIVENESS OF STEROIDS VS PLACEBO IN PREVENTING UPPER AIRWAY OBSTRUCTION AFTER EXTUBATION IN CRITICALLY-ILL CHILDREN: RATIONALE AND DESIGN OF A MULTICENTRIC, DOUBLE-BLIND, RANDOMIZED STUDY

10.21203/rs.2.12891/v3 ◽

2019 ◽

Author(s):

Gema Manrique ◽

Laura Butragueño Laiseca ◽

Rafael González ◽

Corsino Rey ◽

Zuriñe Martínez ◽

...

Keyword(s):

Airway Obstruction ◽

Pediatric Patients ◽

Randomized Study ◽

Upper Airway ◽

Upper Airway Obstruction ◽

Critically Ill Children ◽

Controlled Study ◽

Double Blind ◽

To Receive

Abstract Background: Post-extubation upper airway obstruction (UAO) is a frequent complication causing stridor and respiratory distress, which occasionally may require reintubation, thereby increasing morbidity and mortality rates. Contradictory results have been obtained in studies assessing the effectiveness of steroids in preventing post-extubation UAO, and the available evidence is limited. We designed a multicentric randomized, placebo-controlled study to explore the effectiveness of dexamethasone in preventing post-extubation UAO in children. Methods: A multicentric, prospective, double-blind, randomized, placebo-controlled, phase IV clinical trial has been designed. The sample will include pediatric patients between 1 month and 16 years of age who have been intubated for more than 48 hours. Patients with airway disorders or who have received steroids within the last seven days will be excluded. Patients will be randomized to receive either placebo or a therapy with dexamethasone 0.25 mg/kg every 6 hours to be started 6-to-12 hours prior to extubation, to a total of four doses. Randomization will be performed at a 1:1 ratio. Follow-up of patients will be carried out for 48 h after extubation. The main objective of this study is to assess the reduction of moderate-severe UAO symptoms following extubation, as measured using the Taussig scale. Secondary objectives include assessing the decrease in the incidence of reintubation, evaluating the use of additional therapies for upper airway obstruction, and monitoring dexamethasone potential side effects.Discussion: The results of this study will contribute to the existing evidence on prophylaxis for post-extubation airway obstruction.

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Effectiveness of Steroids Vs Placebo in Preventing Upper Airway Obstruction After Extubation in Critically-ill Children: Rationale and Design of a Multicentric, Double-blind, Randomized Study

10.21203/rs.2.12891/v1 ◽

2019 ◽

Author(s):

Gema Manrique ◽

Laura Butragueño Laiseca ◽

Rafael González ◽

Corsino Rey ◽

Zuriñe Martínez ◽

...

Keyword(s):

Airway Obstruction ◽

Pediatric Patients ◽

Randomized Study ◽

Upper Airway ◽

Upper Airway Obstruction ◽

Critically Ill Children ◽

Controlled Study ◽

Double Blind ◽

To Receive

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Effectiveness of steroids versus placebo in preventing upper airway obstruction after extubation in critically ill children: rationale and design of a multicentric, double-blind, randomized study

Trials ◽

10.1186/s13063-020-4218-2 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Gema Manrique ◽

Laura Butragueño-Laiseca ◽

Rafael González ◽

Corsino Rey ◽

Zuriñe Martínez de Compañon ◽

...

Keyword(s):

Airway Obstruction ◽

Critically Ill ◽

Randomized Study ◽

Upper Airway ◽

Upper Airway Obstruction ◽

Critically Ill Children ◽

Double Blind

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Age at Decannulation after Pediatric Tracheostomy.

10.46940/jecor.02.1006 ◽

2020 ◽

pp. 1-8

Keyword(s):

Airway Obstruction ◽

Medical Records ◽

Chart Review ◽

Pediatric Patients ◽

Upper Airway ◽

Retrospective Chart Review ◽

Upper Airway Obstruction ◽

Neurological Condition ◽

Neurological Conditions

Background: Parents of tracheostomized infants often enquire when their children will undergo decannulation. However, there are few studies on the decannulation of children who are tracheotomized in infancy. Therefore, this study investigated when decannulation should be performed in children by retrospectively analysing medical records. Methods: We performed a retrospective chart review of tracheostomy, decannulation and tracheostoma closure in 48 children who underwent tracheostomy before the age of 3 years. The indications for tracheostomy included upper airway obstruction, neurological conditions, cardiopulmonary conditions, craniofacial conditions and trauma. Result: Nineteen (33.3%) patients were decannulated during the follow-up period: 12 had upper airway obstruction, four had cardiopulmonary conditions, one had a neurological condition and two had craniofacial conditions. The average age at tracheostomy was 13.6 months. The average age at the start of the decannulation therapy was 5.4 years. The average age at decannulation was 7.2 years. The average age at tracheostoma closure was 9.2 years. Conclusion: This description of ages at decannulation after pediatric tracheostomy may be useful when explaining the prognoses and timelines of decannulation to parents and caretakers of pediatric patients who need to undergo tracheostomy.

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Acute upper airway obstruction as a life-threatening complication of ventral bulla osteotomy: report of two consecutive cases

Journal of Feline Medicine and Surgery Open Reports ◽

10.1177/20551169211005923 ◽

2021 ◽

Vol 7 (1) ◽

pp. 205511692110059

Author(s):

Michal Vlasin ◽

Richard Artingstall ◽

Barbora Mala

Keyword(s):

Airway Obstruction ◽

Clinical Signs ◽

Upper Airway ◽

Upper Airway Obstruction ◽

Single Session ◽

Inflammatory Polyp ◽

Case Summary ◽

First Case ◽

Life Threatening

Case summary This paper presents two cases of acute postoperative upper airway obstruction following ventral bulla osteotomy (VBO) in cats. The first cat underwent a unilateral left-sided VBO for a suspected inflammatory polyp. The second cat underwent a single-session bilateral VBO procedure for bilateral otitis media. In the first case, immediate re-intubation and a gradual lightening of the anaesthetic plane resolved the clinical signs; in the second case, the patient deteriorated and went into acute cardiorespiratory arrest and received cardiopulmonary resuscitation. Both patients recovered well and were discharged home 3 days after surgery. Both cases were reported to show no further clinical signs on postoperative follow-up 3 weeks and 4 months after surgery, respectively. Relevance and novel information Upper airway obstruction should be regarded as a potential complication of VBO in cats.

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Phase II, randomized, double blind, placebo-controlled study comparing siltuximab plus bortezomib versus bortezomib alone in pts with relapsed/refractory multiple myeloma.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.8018 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. 8018-8018 ◽

Cited By ~ 9

Author(s):

Robert Z. Orlowski ◽

Liana Gercheva ◽

Cathy Williams ◽

Heather J Sutherland ◽

Tadeusz Robak ◽

...

Keyword(s):

Multiple Myeloma ◽

Overall Response Rate ◽

Randomized Study ◽

Controlled Study ◽

High Dose ◽

Double Blind ◽

Disease Characteristics ◽

Dose Oral ◽

Secondary Endpoints

8018^ Background: Preclinical studies of siltuximab (S), a chimeric anti-IL-6 mAb, in combination with bortezomib (B) indicate an additive to synergistic effect in multiple myeloma (MM) cell lines. This randomized study evaluated the safety and efficacy of S+B compared with placebo (plc)+B in pts with relapsed/refractory MM after 1−3 prior tx lines, measurable disease but no prior B exposure. Methods: 286 pts were randomized 1:1 to S+B: B+plc. S 6 mg/kg or plc was given IV q2w. B 1.3 mg/m2 was given IV on d 1, 4, 8, 11, 22, 25, 29, 32 for a max of 4 of 42-d cycles and then reduced to q1w for 35-d cycles. B was stopped for pts with PD/intolerability, and high dose oral dexamethasone (dex) 40 mg could then be started qd on d 1−4, 9−12, 17−20 for a max of 4 of 28-d cycles and on d 1−4 of subsequent cycles until PD, while S/plc continued. Primary endpoint was PFS by EBMT criteria censored at the start of dex/subsequent tx. Secondary endpoints included overall response rate (ORR), OS, and safety before dex. Results: 142 and 144 pts received S+B and B+plc, respectively. Baseline demographics and disease characteristics were well balanced across S+B and B+plc, except for age (median 64 vs. 61 yrs) and myeloma type (IgG 65 vs. 71%, IgA 27 vs. 20%). Median tx duration was 5.1 mo in both grps. Median PFS was 8.1 mo in S+B and 7.6 mo in B+plc (HR 0.869, p = 0.345). ORR (CR+PR) was 55% in pts on S+B and 47% on B+plc (p = 0.213); CR rates were 11 and 7% (p = 0.342), respectively. With 24.5 mo median follow up, median OS was 30.8 mo for S+B and 36.9 mo for B+plc (HR 1.353 for S+B, p = 0.103). Fewer pts on S+B than B+plc moved to dex (23 vs. 31%) and had subsequent SCT (5 vs. 11%). Gr ≥3 AEs occurred in 91% on S+B and 74% on B+plc. Common gr ≥3 AEs in S+B were neutropenia (49%), thrombocytopenia (48%), leukopenia (14%). SAEs occurred in 29% on S+B and 24% on B+plc. Death occurred within 30 d of last study agent administration pre-dex in 8% on S+B and 5% on B+plc. Conclusions: The combination of S+B had higher response rates but did not prolong survival compared with B+plc. A negative survival trend heavily influenced by differences in dex and SCT rescue was noted. S+B appears to be generally well tolerated but had a higher incidence of hematologic AEs.

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