Nasal HFOV Versus Nasal CPAP to Reduce Post-extubation pCO2
Nasal High Frequency Oscillation Ventilation Versus Nasal Continuous Positive Airway Pressure to Reduce Post-extubation pCO2 in Very Low Birth Weight Infants: a Randomized Controlled Trial
調査の概要
詳細な説明
Randomized controlled clinical trial comparing nHFOV vs nCPAP immediately after extubation of VLBW infants.
Intervention and treatment protocol as described for the two study arms.
Definition of treatment failure (infant meets at least one criterion):
- Sustained pCO2 >80 mmHg and pH <7.20 confirmed by arterial or capillary blood gas analysis in spite of optimized non-invasive respiratory support with maximum settings as defined above.
- Fraction of inspired oxygen (FiO2) >0.6 to maintain peripheral oxygen saturation as measured by pulse oximetry (SpO2) at 90-94% in spite of optimized non-invasive respiratory support with maximum settings as defined above.
- Reintubation (study patients may be intubated at any time, due to clinical considerations, with or without reaching another criterion of "treatment failure").
Sample size:
Assuming a variability of the paCO2 as previously reported for difficult-to-wean preterm infants in our unit (Czernik C, J Matern Fetal Neonatal Med 2012) and a treatment failure rate of 22% within 72 hours after extubation, we calculated a sample size of 34 patients in each study arm to detect a difference in the paCO2 of 7 mmHg, using a two-sided significance of 0.05 and a power of 0.8.
Randomization:
Sequence generation by an independent statistician and a study nurse. Block randomization using at least two different block sizes. Allocation concealment using sequentially numbered opaque sealed envelopes.
Data monitoring:
By an independent statistician.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Berlin、ドイツ
- Dpt. of Neonatology, Charité - Universitätsmedizin Berlin
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Gestational age <32+0 weeks
- Birth weight <1500 g
- Received mechanical ventilation via an endotracheal tube for ≥120 h
- Caffeine treatment according to unit guidelines
- paCO2 <65 mmHg with pH >7.2
- FiO2 25-40% to maintain SpO2 at 90-94%.
- Time-cycled, pressure-controlled ventilation: PIP ≤22 cm H2O, PEEP ≤6 cm H2O; Volume guarantee ventilation: Working Ppeak ≤22 cm H2O, PEEP ≤6 cm H2O; High frequency oscillation ventilation: Pmean ≤12 cm H2O, Amplitude ≤30 cm H2O
- Decision of the attending clinician to extubate
Exclusion Criteria:
- Major congenital malformation requiring surgery
- Duct-dependent congenital heart disease
- Neuromuscular disease
- Participation in another randomized controlled trial
- Death before reaching the eligibility criteria
- Hydrocortisone treatment at the time of enrolment
- Chronological age >28 days
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：nHFOV
Immediately after extubation, nHFOV is provided via binasal prongs. Ventilator settings: Frequency set at 10 Hz, I:E ratio 33:66, amplitude 20 cm H2O, Pmean 8 cm H2O, flow 7 l/min. Set FiO2 to maintain SpO2 at 90-94%. The weaning process is left to the discretion of the attending physician. Maximum amplitude 30 cm H2O, minimum frequency 9 Hz, maximum Pmean 8 cm H2O. For infants in the nHFOV-group who "fail" nHFOV (see definition below), but do not need immediate reintubation, a non-invasive "Rescue-Treatment" may be provided. The decision to attempt "Rescue-Treatment", the mode of respiratory support and the ventilator settings used are at the discretion of the attending clinician. |
Extubation to ventilator-derived nHFOV using binasal prongs
|
|
アクティブコンパレータ：nCPAP
Immediately after extubation, nCPAP is provided via binasal prongs. Ventilator settings: CPAP level set at 8 cm H2O, flow 7 l/min. Set FiO2 to maintain SpO2 at 90-94%. The weaning process is left to the discretion of the attending physician. Maximum CPAP level 8 cm H2O, maximum flow 8 l/min. For infants in the nCPAP-group who "fail" nCPAP (see definition below), but do not need immediate reintubation, "Rescue-nHFOV" via binasal prongs may be provided. The decision to attempt "Rescue-nHFOV" and the ventilator settings used are at the discretion of the attending clinician. |
Extubation to ventilator-derived nCPAP using binasal prongs
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
paCO2 at 72 h After Extubation
時間枠：64 h to 80 h
|
Partial pressure of arterial carbon dioxide assessed between 64 and 80 hours, and on average 72 hours.
|
64 h to 80 h
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
pH at 2 h After Extubation
時間枠：within the first 6 h after extubation
|
within the first 6 h after extubation
|
|
|
paO2 at 2 h After Extubation
時間枠：within the first 6 h after extubation
|
within the first 6 h after extubation
|
|
|
paCO2 at 2 h After Extubation
時間枠：within the first 6 h after extubation
|
within the first 6 h after extubation
|
|
|
Base Excess at 2 h After Extubation
時間枠：within the first 6 h after extubation
|
within the first 6 h after extubation
|
|
|
pH at 72 h After Extubation
時間枠：64-80 h after extubation
|
64-80 h after extubation
|
|
|
paO2 at 72 h After Extubation
時間枠：64-80 h after extubation
|
64-80 h after extubation
|
|
|
Base Excess at 72 h After Extubation
時間枠：64-80 h after extubation
|
64-80 h after extubation
|
|
|
Successful Extubation
時間枠：72 h after extubation
|
Defined as the number of patients breathing spontaneously in their assigned treatment group for ≥72h without reaching the criterion of "treatment failure"
|
72 h after extubation
|
|
Treatment Failure
時間枠：within 7 days after extubation
|
Defined as the number of patients reaching the criterion of "treatment failure"
|
within 7 days after extubation
|
|
Reintubation
時間枠：within 7 days after extubation
|
Defined as the number of patients being reintubated
|
within 7 days after extubation
|
|
Highly Viscous Secretions
時間枠：within 72 hours after extubation
|
Defined as the documented number of episodes of airway obstruction due to highly viscous secretions per patient
|
within 72 hours after extubation
|
|
Other Adverse Effects
時間枠：until discharge
|
Incidences of the following adverse effects: Intraventricular hemorrhage III°-IV° (Papile), surgical necrotizing enterocolitis, pneumothorax, pulmonary interstitial emphysema, persistent ductus arteriosus requiring surgical closure, retinopathy of prematurity requiring laser treatment and/or injection of bevacizumab, death or moderate to severe bronchopulmonary dysplasia (Jobe) at 36 weeks' gestational age, periventricular leukomalacia
|
until discharge
|
|
Duration of Respiratory Support
時間枠：until discharge
|
Total duration of mechanical ventilation, total duration of supplemental oxygen, number of infants discharged with home oxygen
|
until discharge
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
pH at 2 h After Switch to "Rescue Treatment"
時間枠：within the first 6 h after switch to "rescue treatment"
|
within the first 6 h after switch to "rescue treatment"
|
|
|
paO2 at 2 h After Switch to "Rescue Treatment"
時間枠：within the first 6 h after switch to "rescue treatment"
|
within the first 6 h after switch to "rescue treatment"
|
|
|
paCO2 at 2 h After Switch to "Rescue Treatment"
時間枠：within the first 6 h after switch to "rescue treatment"
|
within the first 6 h after switch to "rescue treatment"
|
|
|
Base Excess at 2 h After Switch to "Rescue Treatment"
時間枠：within the first 6 h after switch to "rescue treatment"
|
within the first 6 h after switch to "rescue treatment"
|
|
|
Successful Rescue
時間枠：72 h after switch to "rescue" treatment
|
Defined as spontaneous breathing for ≥72h after starting "rescue" therapy, without reaching the criterion of "treatment failure"
|
72 h after switch to "rescue" treatment
|
協力者と研究者
捜査官
- 主任研究者：Christoph Czernik, MD PhD、Charite University, Berlin, Germany
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。