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Completed

NCT Number: NCT00813176

One-Lung Ventilation in the Morbidly Obese Patient: Comparison of Double Lumen Versus Bronchial Blockers

The purpose of this study is to determine whether the double-lumen endotracheal tube or the standard single-lumen tracheal tube, with an Arndt® blocker, is superior in providing one lung ventilation during thoracic surgery.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa

Iowa City, Iowa, 52241, United States

About this study

The purpose of the study is to compare a double lumen tube versus the standard single-lumen tracheal tube, with an Arndt® blocker, in the morbidly obese patient who requires one-lung ventilation during surgery. The objects is to determine which device is best for intubation and is most effective in terms of optimal positioning of the device, of lung collapse, and quality of lung isolation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject undergoing thoracic or esophageal surgery requiring one-lung ventilation.
  • Subject is >18 years of age.
  • Subject's BMI > 35.

Exclusion criteria

  • Subject < 18 years of age.
  • Subject's BMI < 35.

Treatment and study plan

Double Lumen Endotracheal Tube

Device

Arndt Bronchial Blocker

Device

Primary outcomes

  1. Time Taken for Endotracheal Tube Placement Procedure.

    Time frame: This measurement occurred after the patient was in the operating room and the randomization group was determined. This measurement began and ended during the intubation procedure.

    For each group, the time in minutes required for the anesthesiologist to successfully place the endotracheal tube.

    Intubation time was recorded as the time from when the tracheal tube passed the vocal cords until the anesthetist concluded that the DLT (Arm 1) or the single-lumen tube with the Arndt blocker (Arm 2) was correctly placed and optimal position was confirmed with the fiberoptic bronchoscope.

  2. Number of Participants in Which the Tube Was Successfully Positioned at First Attempt

    Time frame: This data measure was occurred during surgery.

    Number of participants in each group in which the tube was successfully positioned at first attempt

Secondary outcomes

  1. Effectiveness of Lung Collapse

    Time frame: This measure occured during surgery just after intubation.

    For each group, the number of participants in which lung collapse was evaluated as: (i) good-complete collapse without surgical interference, (ii) fair-total collapse, but with residual air, and (iii) poor-no or partial collapse, lung inflated and interfering with the surgical exposure.

  2. Time Required to Collapse the Lung

    Time frame: This measurement occurred during surgery.

    For each group, the mean time for lung isolation/collapse was measured from the institution of one-lung ventilation to the time of total lung collapse.

  3. Number of Participants With Successful Reinflation

    Time frame: This occurred during surgery.

    In each group, the number of Participants in which successful lung reinflation occurred.

  4. Mean Intraoperative Oxygenation During One-lung Ventilation

    Time frame: This measure occured during surgery.

    For each group, the mean intraoperative oxygenation (arterial partial pressure of oxygen measured by arterial blood gases) were taken during two-lung ventilation (baseline) and after 30 min of one-lung ventilation.

Sponsors and collaborators

Lead sponsor

Javier H Campos

Other

Registry information

Official study title

One-Lung Ventilation in Morbidly Obese Patients:

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 22, 2008
Registry last updated
Jun 4, 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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