Change in practice after the Surfactant, Positive Pressure and Oxygenation Randomised Trial

ObjectiveWe sought to determine the effect of stimulation during positive pressure ventilation (PPV) on the number of spontaneous breaths, exhaled tidal volume (VTe), mask leak and obstruction.DesignSecondary analysis of a prospective, randomised trial comparing two face masks.SettingSingle-centre delivery room study.PatientsNewborn infants ≥34 weeks’ gestation at birth.MethodsResuscitations were video recorded. Tactile stimulations during PPV were noted and the timing, duration and surface area of applied stimulus were recorded. Respiratory flow waveforms were evaluated to determine the number of spontaneous breaths, VTe, leak and obstruction. Variables were recorded throughout each tactile stimulation episode and compared with those recorded in the same time period immediately before stimulation.ResultsTwenty of 40 infants received tactile stimulation during PPV and we recorded 57 stimulations during PPV. During stimulation, the number of spontaneous breaths increased (median difference (IQR): 1 breath (0–3); padj<0.001) and VTe increased (0.5 mL/kg (−0.5 to 1.7), padj=0.028), whereas mask leak (0% (−20 to 1), padj=0.12) and percentage of obstructed inflations (0% (0–0), padj=0.14) did not change, compared with the period immediately prior to stimulation. Increased duration of stimulation (padj<0.001) and surface area of applied stimulus (padj=0.026) were associated with a larger increase in spontaneous breaths in response to tactile stimulation.ConclusionsTactile stimulation during PPV was associated with an increase in the number of spontaneous breaths compared with immediately before stimulation without a change in mask leak and obstruction. These data inform the discussion on continuing stimulation during PPV in term infants.Trial registration numberAustralian and New Zealand Clinical Trial Registry (ACTRN12616000768493).

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Randomised trial of patient triggered ventilation versus high frequency positive pressure ventilation in acute respiratory distress

Journal of Perinatal Medicine ◽

10.1515/jpme.1991.19.5.379 ◽

1991 ◽

Vol 19 (5) ◽

pp. 379-384 ◽

Cited By ~ 15

Author(s):

Michael F. Hird ◽

Anne Greenough

Keyword(s):

Respiratory Distress ◽

High Frequency ◽

Positive Pressure Ventilation ◽

Randomised Trial ◽

Positive Pressure ◽

Patient Triggered Ventilation

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Protocol and statistical analysis plan for the PREventing cardiovascular collaPse with Administration of fluid REsuscitation during Induction and Intubation (PREPARE II) randomised clinical trial

BMJ Open ◽

10.1136/bmjopen-2019-036671 ◽

2020 ◽

Vol 10 (9) ◽

pp. e036671

Author(s):

Derek W Russell ◽

Jonathan D Casey ◽

Kevin W Gibbs ◽

James M Dargin ◽

Derek J Vonderhaar ◽

...

Keyword(s):

Tracheal Intubation ◽

Primary Outcome ◽

Randomised Trial ◽

Positive Pressure ◽

Bolus Administration ◽

Cardiovascular Collapse ◽

Fluid Bolus ◽

Institutional Review ◽

Critically Ill Adults ◽

Ill Adults

IntroductionCardiovascular collapse is a common complication during tracheal intubation of critically ill adults. Whether administration of an intravenous fluid bolus prevents cardiovascular collapse during tracheal intubation remains uncertain. A prior randomised trial found fluid bolus administration to be ineffective overall but suggested potential benefit for patients receiving positive pressure ventilation during tracheal intubation.Methods and analysisThe PREventing cardiovascular collaPse with Administration of fluid REsuscitation during Induction and Intubation (PREPARE II) trial is a prospective, multi-centre, non-blinded randomised trial being conducted in 13 academic intensive care units in the USA. The trial will randomise 1065 critically ill adults undergoing tracheal intubation with planned use of positive pressure ventilation (non-invasive ventilation or bag-mask ventilation) between induction and laryngoscopy to receive 500 mL of intravenous crystalloid or no intravenous fluid bolus. The primary outcome is cardiovascular collapse, defined as any of: systolic blood pressure <65 mm Hg, new or increased vasopressor administration between induction and 2 min after intubation, or cardiac arrest or death between induction and 1 hour after intubation. The primary analysis will be an unadjusted, intention-to-treat comparison of the primary outcome between patients randomised to fluid bolus administration and patients randomised to no fluid bolus administration using a χ2 test. The sole secondary outcome is 28-day in-hospital mortality. Enrolment began on 1 February 2019 and is expected to conclude in June 2020.Ethics and disseminationThe trial was approved by either the central institutional review board at Vanderbilt University Medical Center or the local institutional review board at each trial site. Results will be submitted for publication in a peer-reviewed journal and presented at scientific conferences.Trial registration numberNCT03787732.

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Neonatal resuscitation using a laryngeal mask airway: a randomised trial in Uganda

Archives of Disease in Childhood ◽

10.1136/archdischild-2017-312934 ◽

2017 ◽

Vol 103 (3) ◽

pp. 255-260 ◽

Cited By ~ 15

Author(s):

Nicolas J Pejovic ◽

Daniele Trevisanuto ◽

Clare Lubulwa ◽

Susanna Myrnerts Höök ◽

Francesco Cavallin ◽

...

Keyword(s):

Clinical Trial ◽

Laryngeal Mask Airway ◽

Low Income ◽

Spontaneous Breathing ◽

Randomised Trial ◽

Neonatal Resuscitation ◽

Face Mask ◽

Laryngeal Mask ◽

Positive Pressure ◽

Link Type

ObjectiveMortality rates from birth asphyxia in low-income countries remain high. Face mask ventilation (FMV) performed by midwives is the usual method of resuscitating neonates in such settings but may not always be effective. The i-gel is a cuffless laryngeal mask airway (LMA) that could enhance neonatal resuscitation performance. We aimed to compare LMA and face mask (FM) during neonatal resuscitation in a low-resource setting.SettingMulago National Referral Hospital, Kampala, Uganda.DesignThis prospective randomised clinical trial was conducted at the labour ward operating theatre. After a brief training on LMA and FM use, infants with a birth weight >2000 g and requiring positive pressure ventilation at birth were randomised to resuscitation by LMA or FM. Resuscitations were video recorded.Main outcome measuresTime to spontaneous breathing.ResultsForty-nine (24 in the LMA and 25 in the FM arm) out of 50 enrolled patients were analysed. Baseline characteristics were comparable between the two arms. Time to spontaneous breathing was shorter in LMA arm than in FM arm (mean 153 s (SD±59) vs 216 s (SD±92)). All resuscitations were effective in LMA arm, whereas 11 patients receiving FM were converted to LMA because response to FMV was unsatisfactory. There were no adverse effects.ConclusionA cuffless LMA was more effective than FM in reducing time to spontaneous breathing. LMA seems to be safe and effective in clinical practice after a short training programme. Its potential benefits on long-term outcomes need to be assessed in a larger trial.Clinical trial registryThis trial was registered in https://clinicaltrials.gov, with registration number NCT02042118.

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Randomised trial of epinephrine dose and flush volume in term newborn lambs

Archives of Disease in Childhood - Fetal and Neonatal Edition ◽

10.1136/archdischild-2020-321034 ◽

2021 ◽

pp. fetalneonatal-2020-321034 ◽

Cited By ~ 1

Author(s):

Deepika Sankaran ◽

Praveen K Chandrasekharan ◽

Sylvia F Gugino ◽

Carmon Koenigsknecht ◽

Justin Helman ◽

...

Keyword(s):

Cardiac Arrest ◽

Peak Plasma ◽

Geometric Mean ◽

Randomised Trial ◽

Neonatal Resuscitation ◽

Positive Pressure ◽

Plasma Epinephrine ◽

Epinephrine Administration ◽

Resuscitation Guidelines ◽

Epinephrine Dose

ObjectivesNeonatal resuscitation guidelines recommend 0.5–1 mL saline flush following 0.01–0.03 mg/kg of epinephrine via low umbilical venous catheter for persistent bradycardia despite effective positive pressure ventilation (PPV) and chest compressions (CC). We evaluated the effects of 1 mL vs 3 mL/kg flush volumes and 0.01 vs 0.03 mg/kg doses on return of spontaneous circulation (ROSC) and epinephrine pharmacokinetics in lambs with cardiac arrest.DesignForty term lambs in cardiac arrest were randomised to receive 0.01 or 0.03 mg/kg epinephrine followed by 1 mL or 3 mL/kg flush after effective PPV and CC. Epinephrine (with 1 mL flush) was repeated every 3 min until ROSC or until 20 min. Haemodynamics, blood gases and plasma epinephrine concentrations were monitored.ResultsTen lambs had ROSC before epinephrine administration and 2 died during instrumentation. Among 28 lambs that received epinephrine, 2/6 in 0.01 mg/kg-1 mL flush, 3/6 in 0.01 mg/kg-3 mL/kg flush, 5/7 in 0.03 mg/kg-1 mL flush and 9/9 in 0.03 mg/kg-3 mL/kg flush achieved ROSC (p=0.02). ROSC was five times faster with 0.03 mg/kg epinephrine compared with 0.01 mg/kg (adjusted HR (95% CI) 5.08 (1.7 to 15.25)) and three times faster with 3 mL/kg flush compared with 1 mL flush (3.5 (1.27 to 9.71)). Plasma epinephrine concentrations were higher with 0.01 mg/kg-3 mL/kg flush (adjusted geometric mean ratio 6.0 (1.4 to 25.7)), 0.03 mg/kg-1 mL flush (11.3 (2.1 to 60.3)) and 0.03 mg/kg-3 mL/kg flush (11.0 (2.2 to 55.3)) compared with 0.01 mg/kg-1 mL flush.Conclusions0.03 mg/kg epinephrine dose with 3 mL/kg flush volume is associated with the highest ROSC rate, increases peak plasma epinephrine concentrations and hastens time to ROSC. Clinical trials evaluating optimal epinephrine dose and flush volume are warranted.

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Effects of breathing exercises using home-based positive pressure in the expiratory phase in patients with COPD

Postgraduate Medical Journal ◽

10.1136/postgradmedj-2019-136580 ◽

2019 ◽

Vol 95 (1127) ◽

pp. 476-481 ◽

Cited By ~ 1

Author(s):

Qibin Lin ◽

Leying Zhuo ◽

Zhenjie Wu ◽

Chengye Li ◽

Meixi Zhou ◽

...

Keyword(s):

Pulmonary Function ◽

Spontaneous Breathing ◽

Standard Treatment ◽

Randomised Trial ◽

Intervention Group ◽

Positive Pressure ◽

Resistive Load ◽

Breathing Exercise ◽

Breathing Exercises ◽

Home Based

BackgroundPatients with chronic obstructive pulmonary disease (COPD) commonly have higher intrinsic positive end-expiratory pressure (PEEPi). A breathing exercise programme strategy employing an appropriate PEEP may improve their pulmonary functional capacity, exercise tolerance and health-related quality of life. Breathing with an expiratory resistive load, which is a method of modulating spontaneous breathing against PEEPi, has not been fully studied in patients with COPD. The objective of this study was to investigate the role of changing spontaneous breathing in home-based conditions and regulating spontaneous breathing with breathing exercises in patients with COPD.MethodsThis was a prospective randomised trial including 64 patients with a diagnosis of stage III or IV COPD. Patients were randomised into two groups: standard treatment and standard treatment combined with breathing exercise rehabilitation. The effects of the treatments on the COPD assessment test (CAT) score, 6‐minute walk test (6MWT) results and pulmonary function were compared at 0, 6, 12 and 18 months within and between the two groups.ResultsAll outcomes showed no significant differences between the two groups at the beginning of the study, while the 6MWT and CAT scores exhibited clinically and statistically significant improvements (p<0.001) by the end of the study. At month 18, the change in the predicted percentage of forced expiratory volume in 1 s (FEV1%pred) differed between the two groups (p<0.05). In addition, there were statistically significant differences in the 6MWT results, CAT scores and FEV1%pred values between the baseline and month 18 (p<0.0001) in the intervention group.ConclusionsImprovements in 6MWT results, pulmonary function and CAT scores are associated with a successful response to breathing against PEEPi in patients with COPD.Trial registrationThis trial was registered at research registry.com (identifier research registry 4816).

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Smaller facemasks for positive pressure ventilation in preterm infants: A randomised trial

Resuscitation ◽

10.1016/j.resuscitation.2018.12.005 ◽

2019 ◽

Vol 134 ◽

pp. 91-98 ◽

Cited By ~ 5

Author(s):

Eoin O’Currain ◽

Joyce E. O’Shea ◽

Lorraine McGrory ◽

Louise S. Owen ◽

Omar Kamlin ◽

...

Keyword(s):

Preterm Infants ◽

Positive Pressure Ventilation ◽

Randomised Trial ◽

Positive Pressure

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The Assisted Breathing before Cord Clamping (ABC) Study Protocol

Children ◽

10.3390/children8050336 ◽

2021 ◽

Vol 8 (5) ◽

pp. 336

Author(s):

Michael P. Meyer ◽

Elizabeth Nevill

Keyword(s):

Blood Transfusion ◽

Preterm Infants ◽

Controlled Trial ◽

Randomised Trial ◽

Intervention Group ◽

High Risk Group ◽

Positive Pressure ◽

Transfusion Rate ◽

Delayed Cord Clamping ◽

Cord Clamping

Major physiologic changes occur during the transition after birth. For preterm infants, current understanding favours allowing the initial changes to occur prior to cord clamping. Amongst other improved outcomes, systematic reviews have indicated a significant reduction in neonatal blood transfusions following delayed cord clamping. This may be due to a placental transfusion, facilitated by the onset of respiration. If breathing is compromised, placental transfusion may be reduced, resulting in a greater red cell transfusion rate. We designed a randomised trial to investigate whether assisting respiration in this high-risk group of babies would decrease blood transfusion and improve outcomes. The Assisted Breathing before Cord Clamping (ABC) study is a single-centre randomised controlled trial. Preterm infants < 31 weeks that have not established regular breathing before 15 s are randomised to a standard or intervention group. The intervention is intermittent positive pressure ventilation via T piece for 30 s, whilst standard management consists of 30 s of positioning and gentle stimulation. The cord is clamped at 50 s in both groups. The primary outcome is the proportion of infants in each group receiving blood transfusion during the neonatal admission. Secondary outcomes include requirement for resuscitation, the assessment of circulatory status and neonatal outcomes.

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