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"NAVA-PAV" Study: a Cross-over Comparative Study of 2 Advanced Modes

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status and phase

Completed
Phase 3

Conditions

Ventilation Weaning
Critical Illness
Mechanical Ventilation
Intensive Care

Treatments

Other: PAV+ ventilatory mode
Other: NAVA ventilatory mode

Study type

Interventional

Funder types

Other

Identifiers

NCT01607723
UF 8916

Details and patient eligibility

About

Neurally adjusted ventilatory assist (NAVA) and Proportional Assist Ventilatory Plus (PAV +) are new modes of mechanical ventilation that delivers ventilatory assist in proportion to the electrical activity of the diaphragm for NAVA and to patients efforts for PAV +. The goal of this trial is to compare oxygenation,ventilator comfort, patients -ventilator asynchronies, and sleep pattern between NAVA and PAV+.

Full description

Twenty patients will be enrolled. They will be ventilated with PAV+ and NAVA for one day, each in a randomized crossover order. The oxygenation,ventilator comfort, patients -ventilator asynchronies, and sleep pattern will be compared.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Estimated remaining duration of mechanical ventilation for more than two days
  • patient alert and calm
  • Surrogate decision maker's consent

Exclusion criteria

  • Clinical contraindication for the use of NAVA: contraindications for an EAdi catheter placement (e.g., esophageal varices, upper gastrointestinal bleeding, gastroesophageal surgery)
  • Clinical instability for any reason
  • Contraindications for continuing intensive care treatment
  • Patient under tutelage
  • Age < 18 years
  • Pregnancy
  • No French health insurance

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

13 participants in 2 patient groups

NAVA ventilatory mode
Other group
Treatment:
Other: NAVA ventilatory mode
PAV+ ventilatory mode
Other group
Treatment:
Other: PAV+ ventilatory mode

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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