First-attempt success rate of video laryngoscopy in small infants (VISI): a multicentre, randomised controlled trial.


Journal

Lancet (London, England)
ISSN: 1474-547X
Titre abrégé: Lancet
Pays: England
ID NLM: 2985213R

Informations de publication

Date de publication:
12 12 2020
Historique:
received: 15 09 2020
revised: 26 09 2020
accepted: 08 10 2020
entrez: 14 12 2020
pubmed: 15 12 2020
medline: 30 3 2021
Statut: ppublish

Résumé

Orotracheal intubation of infants using direct laryngoscopy can be challenging. We aimed to investigate whether video laryngoscopy with a standard blade done by anaesthesia clinicians improves the first-attempt success rate of orotracheal intubation and reduces the risk of complications when compared with direct laryngoscopy. We hypothesised that the first-attempt success rate would be higher with video laryngoscopy than with direct laryngoscopy. In this multicentre, parallel group, randomised controlled trial, we recruited infants without difficult airways abnormalities requiring orotracheal intubation in operating theatres at four quaternary children's hospitals in the USA and one in Australia. We randomly assigned patients (1:1) to video laryngoscopy or direct laryngoscopy using random permuted blocks of size 2, 4, and 6, and stratified by site and clinician role. Guardians were masked to group assignment. The primary outcome was the proportion of infants with a successful first attempt at orotracheal intubation. Analysis (modified intention-to-treat [mITT] and per-protocol) used a generalised estimating equation model to account for clustering of patients treated by the same clinician and institution, and adjusted for gestational age, American Society of Anesthesiologists physical status, weight, clinician role, and institution. The trial is registered at ClinicalTrials.gov, NCT03396432. Between June 4, 2018, and Aug 19, 2019, 564 infants were randomly assigned: 282 (50%) to video laryngoscopy and 282 (50%) to direct laryngoscopy. The mean age of infants was 5·5 months (SD 3·3). 274 infants in the video laryngoscopy group and 278 infants in the direct laryngoscopy group were included in the mITT analysis. In the video laryngoscopy group, 254 (93%) infants were successfully intubated on the first attempt compared with 244 (88%) in the direct laryngoscopy group (adjusted absolute risk difference 5·5% [95% CI 0·7 to 10·3]; p=0·024). Severe complications occurred in four (2%) infants in the video laryngoscopy group compared with 15 (5%) in the direct laryngoscopy group (-3·7% [-6·5 to -0·9]; p=0·0087). Fewer oesophageal intubations occurred in the video laryngoscopy group (n=1 [<1%]) compared with in the direct laryngoscopy group (n=7 [3%]; -2·3 [-4·3 to -0·3]; p=0·028). Among anaesthetised infants, using video laryngoscopy with a standard blade improves the first-attempt success rate and reduces complications. Anaesthesia Patient Safety Foundation, Society for Airway Management, and Karl Storz Endoscopy.

Sections du résumé

BACKGROUND
Orotracheal intubation of infants using direct laryngoscopy can be challenging. We aimed to investigate whether video laryngoscopy with a standard blade done by anaesthesia clinicians improves the first-attempt success rate of orotracheal intubation and reduces the risk of complications when compared with direct laryngoscopy. We hypothesised that the first-attempt success rate would be higher with video laryngoscopy than with direct laryngoscopy.
METHODS
In this multicentre, parallel group, randomised controlled trial, we recruited infants without difficult airways abnormalities requiring orotracheal intubation in operating theatres at four quaternary children's hospitals in the USA and one in Australia. We randomly assigned patients (1:1) to video laryngoscopy or direct laryngoscopy using random permuted blocks of size 2, 4, and 6, and stratified by site and clinician role. Guardians were masked to group assignment. The primary outcome was the proportion of infants with a successful first attempt at orotracheal intubation. Analysis (modified intention-to-treat [mITT] and per-protocol) used a generalised estimating equation model to account for clustering of patients treated by the same clinician and institution, and adjusted for gestational age, American Society of Anesthesiologists physical status, weight, clinician role, and institution. The trial is registered at ClinicalTrials.gov, NCT03396432.
FINDINGS
Between June 4, 2018, and Aug 19, 2019, 564 infants were randomly assigned: 282 (50%) to video laryngoscopy and 282 (50%) to direct laryngoscopy. The mean age of infants was 5·5 months (SD 3·3). 274 infants in the video laryngoscopy group and 278 infants in the direct laryngoscopy group were included in the mITT analysis. In the video laryngoscopy group, 254 (93%) infants were successfully intubated on the first attempt compared with 244 (88%) in the direct laryngoscopy group (adjusted absolute risk difference 5·5% [95% CI 0·7 to 10·3]; p=0·024). Severe complications occurred in four (2%) infants in the video laryngoscopy group compared with 15 (5%) in the direct laryngoscopy group (-3·7% [-6·5 to -0·9]; p=0·0087). Fewer oesophageal intubations occurred in the video laryngoscopy group (n=1 [<1%]) compared with in the direct laryngoscopy group (n=7 [3%]; -2·3 [-4·3 to -0·3]; p=0·028).
INTERPRETATION
Among anaesthetised infants, using video laryngoscopy with a standard blade improves the first-attempt success rate and reduces complications.
FUNDING
Anaesthesia Patient Safety Foundation, Society for Airway Management, and Karl Storz Endoscopy.

Identifiants

pubmed: 33308472
pii: S0140-6736(20)32532-0
doi: 10.1016/S0140-6736(20)32532-0
pii:
doi:

Banques de données

ClinicalTrials.gov
['NCT03396432']

Types de publication

Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1905-1913

Investigateurs

David Ladner (D)
Nicholas Burjek (N)
Narasimhan Jagannathan (N)
John Hadjuk (J)
Saeedah Asaf (S)
Chris Glover (C)
Mary L Stein (ML)
Ramesh Kodavatiganti (R)
B B Bruins (BB)
Brian Struyk (B)
Luis Sequera-Ramos (L)
Christopher Ward (C)
Elizabeth Laverriere (E)
Harshad Gurnaney (H)
Eric Scheu (E)
Heather Farrell (H)
Paul Stricker (P)
Pilar Castro (P)
Angela Lee (A)
Songyos Valairucha (S)
Judit Szolnoki (J)
Jennifer Zieg (J)
Franklin B Chiao (FB)
Brad M Taicher (BM)
Jurgen C De Graaff (JC)
Nicholas M Dalesio (NM)
Robert S Greenberg (RS)
Angela R Lucero (AR)
Lillian Zamora (L)
Allison Fernandez (A)
Nada Mohamed (N)
Stefano C Sabato (SC)
Christopher D Holmes (CD)
Somaletha T Bhattacharya (ST)
Jonathan Meserve (J)
Paul I Reynolds (PI)
Bishr Haydar (B)
Monica Weber (M)
Megan Therrian (M)
Martina Richtsfeld (M)
Mark S Teen (MS)

Informations de copyright

Copyright © 2020 Elsevier Ltd. All rights reserved.

Auteurs

Annery G Garcia-Marcinkiewicz (AG)

Department of Anesthesiology and Critical Care Medicine, University of Pennsylvania, Perelman School of Medicine, The Children's Hospital of Philadelphia, Philadelphia, PA, USA. Electronic address: garciamara@email.chop.edu.

Pete G Kovatsis (PG)

Department of Anesthesiology, Critical Care and Pain Medicine, Harvard Medical School, Boston Children's Hospital Boston, MA, USA.

Agnes I Hunyady (AI)

Department of Anesthesiology and Pain Medicine, University of Washington School of Medicine, Seattle Children's Hospital, Seattle, WA, USA.

Patrick N Olomu (PN)

Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center, Children's Health System of Texas, Dallas, TX, USA.

Bingqing Zhang (B)

Department of Biomedical and Health Informatics, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.

Madhankumar Sathyamoorthy (M)

Department of Anesthesia, Levine Children's Hospital, Charlotte, NC, USA.

Adolfo Gonzalez (A)

Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center, Children's Health System of Texas, Dallas, TX, USA.

Siri Kanmanthreddy (S)

Department of Anesthesiology and Pain Medicine, University of Washington School of Medicine, Seattle Children's Hospital, Seattle, WA, USA.

Jorge A Gálvez (JA)

Department of Anesthesiology and Critical Care Medicine, University of Pennsylvania, Perelman School of Medicine, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.

Amber M Franz (AM)

Department of Anesthesiology and Pain Medicine, University of Washington School of Medicine, Seattle Children's Hospital, Seattle, WA, USA.

James Peyton (J)

Department of Anesthesiology, Critical Care and Pain Medicine, Harvard Medical School, Boston Children's Hospital Boston, MA, USA.

Raymond Park (R)

Department of Anesthesiology, Critical Care and Pain Medicine, Harvard Medical School, Boston Children's Hospital Boston, MA, USA.

Edgar E Kiss (EE)

Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center, Children's Health System of Texas, Dallas, TX, USA.

David Sommerfield (D)

Department of Anaesthesia and Pain Management, Perth Children's Hospital, University of Western Australia, Nedlands, WA, Australia.

Heather Griffis (H)

Department of Biomedical and Health Informatics, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.

Akira Nishisaki (A)

Department of Anesthesiology and Critical Care Medicine, University of Pennsylvania, Perelman School of Medicine, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.

Britta S von Ungern-Sternberg (BS)

Department of Anaesthesia and Pain Management, Perth Children's Hospital, University of Western Australia, Nedlands, WA, Australia.

Vinay M Nadkarni (VM)

Department of Anesthesiology and Critical Care Medicine, University of Pennsylvania, Perelman School of Medicine, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.

Francis X McGowan (FX)

Department of Anesthesiology and Critical Care Medicine, University of Pennsylvania, Perelman School of Medicine, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.

John E Fiadjoe (JE)

Department of Anesthesiology and Critical Care Medicine, University of Pennsylvania, Perelman School of Medicine, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.

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