Dataset Information

Transnasal Humidified Rapid Insufflation Ventilatory Exchange in children requiring emergent intubation (Kids THRIVE): a protocol for a randomised controlled trial.

ABSTRACT:

Introduction

Emergency intubation of children with abnormal respiratory or cardiac physiology is a high-risk procedure and associated with a high incidence of adverse events including hypoxemia. Successful emergency intubation is dependent on inter-related patient and operator factors. Preoxygenation has been used to maximise oxygen reserves in the patient and to prolong the safe apnoeic time during the intubation phase. Transnasal Humidified Rapid Insufflation Ventilatory Exchange (THRIVE) prolongs the safe apnoeic window for a safe intubation during elective intubation. We designed a clinical trial to test the hypothesis that THRIVE reduces the frequency of adverse and hypoxemic events during emergency intubation in children and to test the hypothesis that this treatment is cost-effective compared with standard care.

Methods and analysis

The Kids THRIVE trial is a multicentre randomised controlled trial performed in participating emergency departments and paediatric intensive care units. 960 infants and children aged 0-16 years requiring emergency intubation for all reasons will be enrolled and allocated to THRIVE or control in a 1:1 allocation with stratification by site, age (<1, 1-7 and >7 years) and operator (junior and senior). Children allocated to THRIVE will receive weight appropriate transnasal flow rates with 100% oxygen, whereas children in the control arm will not receive any transnasal oxygen insufflation. The primary outcomes are defined as follows: (1) hypoxemic event during the intubation phase defined as SpO₂ <90% (patient-dependent variable) and (2) first intubation attempt success without hypoxemia (operator-dependent variable). Analyses will be conducted on an intention-to-treat basis.

Ethics and dissemination

Ethics approval for the protocol and consent process has been obtained (HREC/16/QRCH/81). The trial has been actively recruiting since May 2017. The study findings will be submitted for publication in a peer-reviewed journal.

Trial registration number

ACTRN12617000147381.

SUBMITTER: George S

PROVIDER: S-EPMC6398737 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Publications

Transnasal Humidified Rapid Insufflation Ventilatory Exchange in children requiring emergent intubation (Kids THRIVE): a protocol for a randomised controlled trial.

George Shane S Humphreys Susan S Williams Tara T Gelbart Ben B Chavan Arjun A Rasmussen Katie K Ganeshalingham Anusha A Erickson Simon S Ganu Subodh Suhas SS Singhal Nitesh N Foster Kelly K Gannon Brenda B Gibbons Kristen K Schlapbach Luregn J LJ Festa Marino M Dalziel Stuart S Schibler Andreas A

BMJ open 20190220 2

<h4>Introduction</h4>Emergency intubation of children with abnormal respiratory or cardiac physiology is a high-risk procedure and associated with a high incidence of adverse events including hypoxemia. Successful emergency intubation is dependent on inter-related patient and operator factors. Preoxygenation has been used to maximise oxygen reserves in the patient and to prolong the safe apnoeic time during the intubation phase. Transnasal Humidified Rapid Insufflation Ventilatory Exchange (THRI ...[more]

PMID: 30787094

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Project description:BackgroundTransnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) has received increasing attention and application as an effective noninvasive mode of ventilation in the treatment of clinical anesthesia and critically ill patients. The conclusions reached in clinical studies of THRIVE and facemask oxygenation are still controversial, and the main objective of this systematic review is to determine the advantages of THRIVE over facemask oxygenation in intensive care units, respiratory medicine, and perioperative preoxygenation.MethodsPubMed, Embase, Web of Science, and Cochrane Library have search restrictions. The search library was full of English language articles from the first publication to 15 July 2021. Eligible randomized controlled study designs were included. 245 records were screened, and 5 studies met the inclusion criteria, enrolling a total of 235 patients.ResultsStudying the THRIVE group compared to the facemask group, three studies analyzing intubation time showed that there is no difference in the effect of THRIVE and facemasks (MD -1.22, 95% CI -7.23 to 4.78, and P = 0.69 > 0.05). Three studies analyzing apnea showed that there was no difference between the two groups (SMD 1, 95% CI -0.76 to 2.76, and P = 0.27 > 0.05). Three studies analyzing PaO2 after preoxygenation showed that THRIVE is more effective than facemasks (MD 72.58, 95% CI 31.25 to 113.90, Z = 3.44, and P < 0.001). Two studies analyzing oxygen saturation SpO2 after successful intubation showed that there was no difference in the effectiveness (MD 0.09, 95% CI -1.03 to 1.22, and P = 0.87 > 0.05). Two studies analyzing PCO2 after complete paralysis or intubation preoxygenation showed that there was no difference between the two groups (MD 2.76, 95% CI -1.74 to 7.26, and P = 0.23 > 0.05).ConclusionsTHRIVE does not have a greater advantage over a facemask in improving apnea time, oxygenation time, PCO2, and SpO2, but it has an advantage in improving arterial partial pressure of oxygen (PaO2) after preoxygenation, which can improve PaO2 well. This trial is registered with the protocol registration number CRD42021268143.

Project description:BACKGROUND:Animal studies have shown that peritoneal injury can be minimized by insufflating the abdominal cavity with warm humidified carbon dioxide gas. METHODS:A single-blind RCT was performed at a tertiary colorectal unit. Inclusion criteria were patient aged 18?years and over undergoing open elective surgery. The intervention group received warmed (37°C), humidified (98 per cent relative humidity) carbon dioxide (WHCO2 group). Multiple markers of peritoneal inflammation and oxidative damage were used to compare groups, including cytokines and chemokines, apoptosis, the 3-chlorotyrosine/native tyrosine ratio, and light microscopy on peritoneal biopsies at the start (T0 ) and end (Tend ) of the operation. Postoperative clinical outcomes were compared between the groups. RESULTS:Of 40 patients enrolled, 20 in the WHCO2 group and 19 in the control group were available for analysis. A significant log(Tend /T0 ) difference between control and WHCO2 groups was documented for interleukin (IL) 2 (5·3 versus 2·8 respectively; P = 0·028) and IL-4 (3·5 versus 2·0; P = 0·041), whereas apoptosis assays documented no significant change in caspase activity, and similar apoptosis rates were documented along the peritoneal edge in both groups. The 3-chlorotyrosine/tyrosine ratio had increased at Tend by 1·1-fold in the WHCO2 group and by 3·1-fold in the control group. Under light microscopy, peritoneum was visible in 11 of 19 samples from the control group and in 19 of 20 samples from the WHCO2 group (P = 0·006). The only difference in clinical outcomes between intervention and control groups was the number of days to passage of flatus (2·5 versus 5·0?days respectively; P = 0·008). CONCLUSION:The use of warmed, humidified carbon dioxide appears to reduce some markers related to peritoneal oxidative damage during laparotomy. No difference was observed in clinical outcomes, but the study was underpowered for analysis of surgical results. Registration number: NCT02975947 ( www.ClinicalTrials.gov/).

Dataset Information

Transnasal Humidified Rapid Insufflation Ventilatory Exchange in children requiring emergent intubation (Kids THRIVE): a protocol for a randomised controlled trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Transnasal Humidified Rapid Insufflation Ventilatory Exchange in children requiring emergent intubation (Kids THRIVE): a protocol for a randomised controlled trial.

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