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CompletedNCT03550924Updated Sep 2, 2020

Transnasal Humidified Rapid Insufflation Ventilatory Exchange in Morbidly Obese

An interventional study of low flow passive oxygenation and high flow passive oxygenation in Anesthesia Intubation Complication and Anesthesia, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-09-02.

Sponsored by Medical University of Vienna · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
19 Years to 65 Years
Sex
All
01

Study summary

This project will investigate the duration of apnea without desaturation when using transnasal humidified rapid insufflation ventilatory exchange (THRIVE) vs. low flow nasal oxygen at anesthesia induction in obese patients.

Read the detailed description

Background Providing safe anesthesia for surgery in obese patients requires specific consideration of the pathophysiological changes and respiratory complications are frequent. Anesthesia induction needs special attention in this patient population. A decrease in functional residual capacity (FRC) after induction of anesthesia dramatically shortens the duration of apnea without desaturation (DAWD) during which the airway can be secured.

Several measures such as positioning in a semi sitting position, preoxygenation with PEEP and passive insufflation of oxygen during laryngoscopy have been shown to prolong the DAWD. None of these measures is able to produce positive endexpiratory pressure (PEEP) during laryngoscopy which would counteract the loss of FRC and therefore prolong the DAWD further.

Transnasal humidified rapid insufflation ventilator exchange (THRIVE, also knowns as "high flow nasal oxygen therapy" and "heated and humidified nasal oxygen") devices have been used for several years in intensive care and are available from numerous vendors. With THRIVE, heated and humidified oxygen is insufflated via nasal prongs at a rate up to 120 l/minute and it has been shown that this creates levels of PEEP, proportional to the amount of gas flow. Using THRIVE during the apneic phase of anesthesia induction in obese patients might be superior compared to low flow oxygen techniques as THRIVE generates PEEP during laryngoscopy, which might counteract the loss of FRC and consequently might prolong the DAWD.

Aim of the project This project will investigate the DAWD when using THRIVE vs. low flow nasal oxygen at anesthesia induction in obese patients.

Hypothesis The duration of apnea without desaturation is longer in the "THRIVE" group compared to the "low flow oxygen" group.

Methods The study will be conducted as a single center, prospective, randomized, controlled trial at the Medical University of Vienna, Austria.

Forty adult patients of the ASA classification 2 and 3 with a BMI >40 undergoing elective surgery under general anesthesia will be included. Patients with expected difficult airway, patients with an oxygen saturation \<98% despite preoxygenation, patients with nasal obstruction, smokers (>10 cigarettes/day), patients with chronic respiratory disease, patients unable to give consent, and pregnant or breastfeeding patients will be excluded.

Patients will be randomly assigned to one of two groups ("low flow oxygen" or "THRIVE" group) and anesthesia will be induced in a standardized fashion in both groups. During laryngoscopy, patients in the low flow group will receive nasal oxygen insufflation at a rate of 10 l/min and patients in the THRIVE group will receive oxygen at a rate of 120 l/min via a THRIVE system. Difficult laryngoscopy will be simulated and intubation will be performed as soon as oxygen saturation drops to 95%. The time from anesthesia induction until oxygen saturation drops to 95% (DAWD) will be measured.

02

Conditions studied

  • Anesthesia Intubation Complication
  • Anesthesia
03

In context

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult patients
  • American Society of Anesthesiologists physical status classification class 2-3
  • BMI > 40
  • elective surgery under general anesthesia

Exclusion criteria

Exclusion Criteria:

  • expected difficult airway (El Ganzouri Risk Index > 6)
  • oxygen saturation of less than 98% despite adequate preoxygenation,
  • nasal obstruction
  • smoker, more than 10 cigarettes per day
  • chronic respiratory disease
  • FEV1 (forced expiratory volume in one second) \< 70%
  • elevated intracranial pressure
  • unable to give informed consent
  • Pregnant or breast feeding
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Low flow Oxygen Group

    low flow passive oxygenation during laryngoscopy with 10l/min oxygen via standard nasal prongs

    Procedure: low flow passive oxygenation

  • Experimental
    THRIVE Group

    high flow passive oxygenation during laryngoscopy with 120l/min oxygen via THRIVE system

    Procedure: high flow passive oxygenation

Interventions

  • Procedurelow flow passive oxygenation

    low flow passive oxygenation during laryngoscopy with 10l/min oxygen via standard nasal prongs

  • Procedurehigh flow passive oxygenation

    high flow passive oxygenation during laryngoscopy with 120l/min oxygen via THRIVE system

06

What researchers measure

Primary outcomes

  1. Duration of safe apnea

    The duration until oxygen saturation drops to 95% during laryngoscopy

    Time frame: duration from the application of rocuronium until the oxygen saturation drops to 95% during laryngoscopy or a maximum of 15 minutes if the oxygen saturation does not drop to this level.

Secondary outcomes

  1. blood gas analysis

    arterial blood samples will be taken every 2 minutes after rocuronium was given until 2 minutes after intubation

    Time frame: every 2 minutes after rocuronium was given until 2 minutes after intubation

07

Study locations

1 site
  • Medical University of Vienna
    Vienna, 1090, Austria
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References and documents

Individual participant data

Plan to share: Undecided — not yet decided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03550924
Lead sponsor
Medical University of Vienna
Responsible party
Thomas Hamp (Principal Investigator, Medical University of Vienna) — Principal investigator
First posted
Jun 8, 2018
Start date
Jul 26, 2018
Primary completion
Jan 22, 2020
Completion
Jan 22, 2020
Last update
Sep 2, 2020

Study contacts

Thomas Hamp, Doctor
principal investigator · Department of Anaesthesia and Intensive Care Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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