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OpenTrials
Completed

NCT Number: NCT04125342

Postextubation High-flow Therapy vs Noninvasive Ventilation in Obese or at High-risk Patients

The main aim is to demonstrate whether reintubation rate is lower with preventive conditioned noninvasive ventilation (NIV) rather than with High-flow oxygen therapy (HFOT) in obese intermediate-risk patients and in high-risk patients.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Virgen de la Salud, Toledo, Castille-La Mancha, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • High-Risk Patients: Patients under mechanical ventilation for more than 24 hours considered at high risk according to the presence of more than 3 of the following risk factors:
  • >65 years.
  • Cardiac failure as the primary indication of mechanical ventilation.
  • Moderate to severe chronic obstructive pulmonary disease.
  • APACHE II >12 points the extubation day.
  • Body mass index >30.
  • Inability to manage respiratory secretions.
  • Not simple weaning.
  • More than 1 comorbidity.
  • More than 7 days under mechanical ventilation.
  • Hypercapnia during the spontaneous breathing trial.
  • Airway patency problems.
  • Obese Intermediate Risk Patients: Patients under mechanical ventilation for more than 24 hours with a Body mass index >30 and considered at intermediate risk according to the presence of less than 3 of the following risk factors:
  • >65 years.
  • Cardiac failure as the primary indication of mechanical ventilation.
  • Moderate to severe chronic obstructive pulmonary disease.
  • APACHE II >12 points the extubation day.
  • Inability to manage respiratory secretions.
  • Not simple weaning.
  • More than 1 comorbidity.
  • More than 7 days under mechanical ventilation.
  • Airway patency problems.

Exclusion criteria

  • <18 years.
  • Thacheotomized patients.
  • Contraindications for NIV (recent facial or cervical trauma/surgery, active gastro-intestinal bleeding, lack of cooperation).
  • Unscheduled extubation.
  • Do not reintubate orders.
  • No informed consent.

Treatment and study plan

Preventive Conditioned NIV Therapy after planned extubation

Device

Conditioned NIV during 48 hours following extubation.

Preventive HFOT after planned extubation

Device

HFOT set according to patients tolerance during 48 hours following extubation

Primary outcomes

  1. Reintubation rate

    Time frame: 7 days

Secondary outcomes

  1. Intensive Care Unit mortality rate

    Time frame: 3 months

  2. Hospital mortality rate

    Time frame: 3 months

  3. Intensive Care Unit length of stay

    Time frame: 3 months

  4. Hospital length of stay

    Time frame: 6 months

  5. Respiratory infection rate

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Hospital Virgen de la Salud

Other

Registry information

Official study title

Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation in Obese or High-Risk Patients. A Randomized Clinical Trial.

Acronym: HINFOR

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 14, 2019
Registry last updated
Mar 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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