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OpenTrials
Completed

NCT Number: NCT03155711

HFNC for Induction During Bariatric Surgery Patients.

This study aims to compared the effects of high flow nasal during the induction and during the weaning of anesthesia on intraoperative and postoperative oxygenation and postoperative atelectasis in obese patients undergoing bariatric surgery versus the standard of care, which consists in supplemental oxygen with face mask (Venturi mask).

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Key information

Conditions

Lung Collapse Lung Diseases Pulmonary Atelectasis Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital clínico universitario

Valencia, 46010, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Body mass index > 35 Kg/m2
  • Bariatric surgery
  • Informed consent signed

Exclusion criteria

  • age <18yr or >80yr
  • pregnancy or breast-feeding status
  • patients with previous known respiratory disease
  • hemodynamic instability at entry (need of vasopressors or ionotropes at entry or a ventricular assist device

Treatment and study plan

HFNC group

Procedure

Positive pressure plus supplemental oxygen through a high flow nasal oxygen device

Standard group

Procedure

Supplemental oxygen through venturi mask

Primary outcomes

  1. Oxygenation

    Time frame: intraoperative

    The oxygenation (the ratio of partial pressure of arterial oxygen with inspiratory oxygen fraction, PaO2/FIO2) informs of the percentadge of shunt.

Secondary outcomes

  1. Oxygenation

    Time frame: First 24 postoperative hours

    PaO2/FIO2

  2. Atelectasis

    Time frame: First 24 postoperative hours

    Atelectasis evaluated with X-ray

Sponsors and collaborators

Lead sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Other

Registry information

Official study title

Study Protocol for the Use of High Flow Nasal Oxygen During the Anesthesia Induction and Weaning in Patients Scheduled for Bariatric Surgery. A Randomized Pilot Study

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 16, 2017
Registry last updated
Feb 26, 2018

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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