Dataset Information

Respiratory outcomes of the surfactant positive pressure and oximetry randomized trial (SUPPORT).

ABSTRACT: OBJECTIVE:To explore the early childhood pulmonary outcomes of infants who participated in the National Institute of Child Health and Human Development's Surfactant Positive Airway Pressure and Pulse Oximetry Randomized Trial (SUPPORT), using a factorial design that randomized extremely preterm infants to lower vs higher oxygen saturation targets and delivery room continuous positive airway pressure (CPAP) vs intubation/surfactant. STUDY DESIGN:The Breathing Outcomes Study, a prospective secondary study to the Surfactant Positive Airway Pressure and Pulse Oximetry Randomized Trial, assessed respiratory morbidity at 6-month intervals from hospital discharge to 18-22 months corrected age (CA). Two prespecified primary outcomes-wheezing more than twice per week during the worst 2-week period and cough longer than 3 days without a cold-were compared for each randomized intervention. RESULTS:One or more interviews were completed for 918 of the 922 eligible infants. The incidences of wheezing and cough were 47.9% and 31.0%, respectively, and did not differ between the study arms of either randomized intervention. Infants randomized to lower vs higher oxygen saturation targets had a similar risk of death or respiratory morbidity (except for croup and treatment with oxygen or diuretics at home). Infants randomized to CPAP vs intubation/surfactant had fewer episodes of wheezing without a cold (28.9% vs 36.5%; P<.05), respiratory illnesses diagnosed by a doctor (47.7% vs 55.2%; P<.05), and physician or emergency room visits for breathing problems (68.0% vs 72.9%; P<.05) by 18-22 months CA. CONCLUSION:Treatment with early CPAP rather than intubation/surfactant is associated with less respiratory morbidity by 18-22 months CA. Longitudinal assessment of pulmonary morbidity is necessary to fully evaluate the potential benefits of respiratory interventions for neonates.

SUBMITTER: Stevens TP

PROVIDER: S-EPMC4111960 | biostudies-literature | 2014 Aug

REPOSITORIES: biostudies-literature

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Respiratory outcomes of the surfactant positive pressure and oximetry randomized trial (SUPPORT).

Stevens Timothy P TP Finer Neil N NN Carlo Waldemar A WA Szilagyi Peter G PG Phelps Dale L DL Walsh Michele C MC Gantz Marie G MG Laptook Abbot R AR Yoder Bradley A BA Faix Roger G RG Newman Jamie E JE Das Abhik A Do Barbara T BT Schibler Kurt K Rich Wade W Newman Nancy S NS Ehrenkranz Richard A RA Peralta-Carcelen Myriam M Vohr Betty R BR Wilson-Costello Deanne E DE Yolton Kimberly K Heyne Roy J RJ Evans Patricia W PW Vaucher Yvonne E YE Adams-Chapman Ira I McGowan Elisabeth C EC Bodnar Anna A Pappas Athina A Hintz Susan R SR Acarregui Michael J MJ Fuller Janell J Goldstein Ricki F RF Bauer Charles R CR O'Shea T Michael TM Myers Gary J GJ Higgins Rosemary D RD

The Journal of pediatrics 20140413 2

<h4>Objective</h4>To explore the early childhood pulmonary outcomes of infants who participated in the National Institute of Child Health and Human Development's Surfactant Positive Airway Pressure and Pulse Oximetry Randomized Trial (SUPPORT), using a factorial design that randomized extremely preterm infants to lower vs higher oxygen saturation targets and delivery room continuous positive airway pressure (CPAP) vs intubation/surfactant.<h4>Study design</h4>The Breathing Outcomes Study, a pros ...[more]

PMID: 24725582

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Project description:Rationale: The respective effects of positive end-expiratory pressure (PEEP) and pressure support delivered through the helmet interface in patients with hypoxemia need to be better understood. Objectives: To assess the respective effects of helmet pressure support (noninvasive ventilation [NIV]) and continuous positive airway pressure (CPAP) compared with high-flow nasal oxygen (HFNO) on effort to breathe, lung inflation, and gas exchange in patients with hypoxemia (PaO2/FiO2 ⩽ 200). Methods: Fifteen patients underwent 1-hour phases (constant FiO2) of HFNO (60 L/min), helmet NIV (PEEP = 14 cm H2O, pressure support = 12 cm H2O), and CPAP (PEEP = 14 cm H2O) in randomized sequence. Measurements and Main Results: Inspiratory esophageal (ΔPES) and transpulmonary pressure (ΔPL) swings were used as surrogates for inspiratory effort and lung distension, respectively. Tidal Volume (Vt) and end-expiratory lung volume were assessed with electrical impedance tomography. ΔPES was lower during NIV versus CPAP and HFNO (median [interquartile range], 5 [3-9] cm H2O vs. 13 [10-19] cm H2O vs. 10 [8-13] cm H2O; P = 0.001 and P = 0.01). ΔPL was not statistically different between treatments. PaO2/FiO2 ratio was significantly higher during NIV and CPAP versus HFNO (166 [136-215] and 175 [158-281] vs. 120 [107-149]; P = 0.002 and P = 0.001). NIV and CPAP similarly increased Vt versus HFNO (mean change, 70% [95% confidence interval (CI), 17-122%], P = 0.02; 93% [95% CI, 30-155%], P = 0.002) and end-expiratory lung volume (mean change, 198% [95% CI, 67-330%], P = 0.001; 263% [95% CI, 121-407%], P = 0.001), mostly due to increased aeration/ventilation in dorsal lung regions. During HFNO, 14 of 15 patients had pendelluft involving >10% of Vt; pendelluft was mitigated by CPAP and further by NIV. Conclusions: Compared with HFNO, helmet NIV, but not CPAP, reduced ΔPES. CPAP and NIV similarly increased oxygenation, end-expiratory lung volume, and Vt, without affecting ΔPL. NIV, and to a lesser extent CPAP, mitigated pendelluft. Clinical trial registered with clinicaltrials.gov (NCT04241861).

Project description:ImportanceThe optimal first-line mode of noninvasive respiratory support following extubation of critically ill children is not known.ObjectiveTo evaluate the noninferiority of high-flow nasal cannula (HFNC) therapy as the first-line mode of noninvasive respiratory support following extubation, compared with continuous positive airway pressure (CPAP), on time to liberation from respiratory support.Design, setting, and participantsThis was a pragmatic, multicenter, randomized, noninferiority trial conducted at 22 pediatric intensive care units in the United Kingdom. Six hundred children aged 0 to 15 years clinically assessed to require noninvasive respiratory support within 72 hours of extubation were recruited between August 8, 2019, and May 18, 2020, with last follow-up completed on November 22, 2020.InterventionsPatients were randomized 1:1 to start either HFNC at a flow rate based on patient weight (n = 299) or CPAP of 7 to 8 cm H2O (n = 301).Main outcomes and measuresThe primary outcome was time from randomization to liberation from respiratory support, defined as the start of a 48-hour period during which the child was free from all forms of respiratory support (invasive or noninvasive), assessed against a noninferiority margin of an adjusted hazard ratio (HR) of 0.75. There were 6 secondary outcomes, including mortality at day 180 and reintubation within 48 hours.ResultsOf the 600 children who were randomized, 553 children (HFNC, 281; CPAP, 272) were included in the primary analysis (median age, 3 months; 241 girls [44%]). HFNC failed to meet noninferiority, with a median time to liberation of 50.5 hours (95% CI, 43.0-67.9) vs 42.9 hours (95% CI, 30.5-48.2) for CPAP (adjusted HR, 0.83; 1-sided 97.5% CI, 0.70-∞). Similar results were seen across prespecified subgroups. Of the 6 prespecified secondary outcomes, 5 showed no significant difference, including the rate of reintubation within 48 hours (13.3% for HFNC vs 11.5 % for CPAP). Mortality at day 180 was significantly higher for HFNC (5.6% vs 2.4% for CPAP; adjusted odds ratio, 3.07 [95% CI, 1.1-8.8]). The most common adverse events were abdominal distension (HFNC: 8/281 [2.8%] vs CPAP: 7/272 [2.6%]) and nasal/facial trauma (HFNC: 14/281 [5.0%] vs CPAP: 15/272 [5.5%]).Conclusions and relevanceAmong critically ill children requiring noninvasive respiratory support following extubation, HFNC compared with CPAP following extubation failed to meet the criterion for noninferiority for time to liberation from respiratory support.Trial registrationisrctn.org Identifier: ISRCTN60048867.

Project description:BackgroundAdding cyclic short sustained inflations (sigh) to assisted ventilation yields optimizes lung recruitment, decreases heterogeneity and reduces inspiratory effort in patients with acute hypoxemic respiratory failure (AHRF). These findings suggest that adding sigh to pressure support ventilation (PSV) might decrease the risk of lung injury, shorten weaning and improve clinical outcomes. Thus, we conceived a pilot trial to test the feasibility of adding sigh to PSV (the PROTECTION study).MethodsPROTECTION is an international randomized controlled trial that will be conducted in 23 intensive care units (ICUs). Patients with AHRF who have been intubated from 24 h to 7 days and undergoing PSV from 4 to 24 h will be enrolled. All patients will first undergo a 30-min sigh test by adding sigh to clinical PSV for 30 min to identify early oxygenation responders. Then, patients will be randomized to PSV or PSV + sigh until extubation, ICU discharge, death or day 28. Sigh will be delivered as a 3-s pressure control breath delivered once per minute at 30 cmH2O. Standardized protocols will guide ventilation settings, switch back to controlled ventilation, use of rescue treatments, performance of spontaneous breathing trial, extubation and reintubation. The primary endpoint of the study will be to verify the feasibility of PSV + sigh evaluated through reduction of failure to remain on assisted ventilation during the first 28 days in the PSV + sigh group versus standard PSV (15 vs. 22%). Failure will be defined by switch back to controlled ventilation for more than 24 h or use of rescue treatments or reintubation within 48 h from elective extubation. Setting the power to 80% and first-risk order to 5%, the computed size of the trial is 129 patients per arm.DiscussionPROTECTION is a pilot randomized controlled trial testing the feasibility of adding sigh to PSV. If positive, it will provide physicians with an effective addition to standard PSV for lung protection, able to reduce failure of assisted ventilation. PROTECTION will provide the basis for a future larger trial aimed at verifying the impact of PSV + sigh on 28-day survival and ventilator-free days.Trial registrationClinicalTrials.gov, NCT03201263 . Registered on 28 June 2017.

Project description:BackgroundPressure support (PS) as a spontaneous breathing trial (SBT) was considered inferior to continuous positive airway pressure (CPAP) and T-piece because PS underestimated post-extubation work of breathing in physiologic studies. We aimed to compare PS and CPAP as SBT methods for assessing clinical outcomes in children.MethodsThis was an open label randomized non-inferiority trial conducted between December 2019 and August 2021 among children aged 1 month to 12 years deemed ready for weaning after at least 48 h of invasive ventilation in PICU. Children were randomized to undergo a 2-h SBT with PS of 8 cm H2O in addition to PEEP 5-6 cm H2O or CPAP (5-6 cm H2O). The primary outcome was successful liberation from invasive ventilation for 72 h after first SBT. Secondary outcomes included first SBT pass rate, need for post-extubation respiratory support (high flow oxygen and/or non-invasive ventilation), and length of PICU stay.FindingsOf the 247 enrolled children, 244 completed the trial (121 in PS and 123 in CPAP group). Median (IQR) age was 24 (9, 84) months. Median (IQR) duration of invasive ventilation before randomization was 4.5 (3, 6.5) days. Successful liberation from invasive ventilation after first SBT occurred in 97 (80.2%) children in PS and 93 (75.6%) children in CPAP group [difference 4.6; 95% CI (-5.8, 15); p = 0.39]. First SBT pass rate between PS and CPAP [111 (91.7%) versus 105 (85.4%); difference 6.3; 95% CI (-1.6, 14.3); p = 0.12] was similar. Need for post-extubation respiratory support [52 (43%) versus 49 (40%)], rate of reintubation within 72 h [14 (11.6%) versus 12 (9.8%)] and median (IQR) length of PICU stay [9 (6, 15) versus 8 (5.5, 13) days] were comparable. Four (1.6%) children, all in CPAP group had unfavourable outcome (1 died, 3 discontinued care).InterpretationIn invasively ventilated children, 2-h SBT with pressure support was non-inferior to CPAP in predicting successful liberation from invasive ventilation.FundingNone.

Dataset Information

Respiratory outcomes of the surfactant positive pressure and oximetry randomized trial (SUPPORT).

Publications

Respiratory outcomes of the surfactant positive pressure and oximetry randomized trial (SUPPORT).

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