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. 2023 Nov 20;2023(11):CD015532. doi: 10.1002/14651858.CD015532

Avilés‐Jurado 2020.

Study characteristics
Methods

  • Trial design: single‐center prospective cohort study

  • Type of publication: journal publication

  • Setting: inpatient

  • Recruitment dates: from 16 March‐10 April 2020, final date for data cut‐off was 14 April 2021

  • Country: Spain

  • Language: English

  • Number of centers: 1 tertiary referral center (ICU)
Participants Baseline characteristics

  • Number randomised (in total and per arm): (recruited/evaluated): 50/50, intervention ‐ ET: 32/32, control ‐ LT: 18/18

  • Age (mean(SD)): intervention group 62.6 (11.6), control group 64.53 (8.2)

  • Gender (male, n (%)): intervention group 22 (68.7), control group 11 (61.1)

  • Comorbidities (intervention group vs control group (n/N (%))):

    • cardiovascular disease 9/56 (16) vs 15/61 (25)

    • hypertension 19/32 (59.4) vs 8/18 (44.4)

    • diabetes mellitus 8/32 (25) vs 1/18 (5.6)

    • immunosuppression 2/32 (6.3) vs 2/18 (11.1)

    • autoimmune disease 2/32 (6.3) vs 1 (5.6)

    • > 2 comorbidities 18/32 (56.2) vs 7/18 (38.8)

    • SOFA score, mean (SD) 6.3/32 (2.1) vs 6/18 (2.5)

    • APACHE II score, mean (SD) 14.16/32 (4.3) vs 11.9/18 (3.9)


Inclusion criteria

  • Adult patients with confirmed COVID‐19 who were admitted to the ICU and required tracheostomy between 16 March and 10 April 2020


Exclusion criteria

  • Not defined
Interventions The main exposure variable was ET versus LT

  • Procedure: a surgical tracheostomy was performed for all patients at the bedside (in the ICU) following recommended criteria for use of PPE

  • Treatment details of intervention group: 'early' ‐ patients who were on MV for ≤ 10 days prior to surgery

  • Treatment details of control group: 'late' was defined as occurring later than 10 days after orotracheal intubation
Outcomes Primary study outcome

  • Number of subthyroid operations

  • Tracheal entrance protocol

  • Ise of PPE


Secondary study outcome

  • Infections among the surgeons were monitored weekly by RT–PCR of nasopharyngeal swab samples, short‐term complications, weaning, and the association of timing of tracheostomy (early [≤ 10 days] vs late [> 10 days]) with total required days of IMV were assessed


Review outcomes

  • Mortality:

    • overall mortality (NR)

    • in‐hospital mortality (NR)

    • at up to day 28 (± 2) (NR)

    • at day 60 (NR)

    • at day 90 (NR)

    • time‐to‐event (NR)

  • Improvement of clinical status:

    • duration to liberation from IMV (R)

    • need for IMV (NR)

    • liberation from IMV (NR)

    • ventilator‐free days (NR)

    • time to decannulation (R)

  • Worsening of clinical status:

    • AEs (any grade) (NR)

    • ventilator‐associated pneumonia (NR)

    • need for renal replacement therapy (NR)

    • postoperative bleeding (R)

    • airway obstruction (NR)

    • tracheal stenosis (NR)

    • need for ECMO (NR)

    • ventilatory problems (R)

    • SAEs (NR)

  • ICU length of stay, or time to discharge from ICU (NR)

  • Hospital length of stay, or time to discharge from hospital (NR)

  • Quality of life (NR)

  • Viral clearance (NR)
Notes