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

NCT00813176 | Completed Results DMC

• 1 other identifier: 200701755
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Keywords

Obesity; One-Lung Ventilation; Anesthesia; Thoracic; One-lung ventilation in the morbidly obese patient

Outcome Measures

Primary Outcomes (2)

• Time Taken for Endotracheal Tube Placement 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.

  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.

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

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

  This data measure was occurred during surgery.

Secondary Outcomes (4)

• Effectiveness of Lung Collapse

  This measure occured during surgery just after intubation.

• Time Required to Collapse the Lung

  This measurement occurred during surgery.

• Number of Participants With Successful Reinflation

  This occurred during surgery.

• Mean Intraoperative Oxygenation During One-lung Ventilation

  This measure occured during surgery.

Study Arms (2)

Double Lumen Endotracheal Tube

ACTIVE COMPARATOR

We used a device called a double lumen tube ( DLT Broncho-Cath®). It is a bifurcated endotracheal tube designed to independently collapse the operated lung.

Device: Double Lumen Endotracheal Tube

Arndt Bronchial Blocker

ACTIVE COMPARATOR

We used a device called a bronchial blocker (9 Fr Arndt® blocker) along with a standard single-lumen tracheal tube (8.0-9.0 mm ID). The Arndt bronchial blocker is a single device, with a distal balloon that is passed thru the single lumen endotracheal once the patient is intubated. The Arndt bronchial blocker is designed to collapse the operated lung.

Device: Arndt Bronchial Blocker

Interventions

Double Lumen Endotracheal Tube DEVICE

Double Lumen Endotracheal Tube

Arndt Bronchial Blocker DEVICE

Arndt Bronchial Blocker

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Javier H Campos: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52241, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr Javier H Campos
• Organization: University of Iowa

javier-campos@uiowa.edu

3193567208

Study Officials

• Javier H Campos, MD

  Iowa Health Care

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor in Anesthesia

Model Details: prospective randomized study

Study Record Dates

• First Submitted: December 18, 2008
• First Posted: December 22, 2008
• Study Start: March 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 4, 2018
• Results First Posted: June 4, 2018

Record last verified: 2018-05

Locations

US (1)