Trials Sponsors Conditions Drugs Pricing

Conditions

Obesity

Keywords

ObesityOne-Lung VentilationAnesthesiaThoracicOne-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 TubeDevice

Double Lumen Endotracheal Tube

Arndt Bronchial BlockerDevice

Arndt Bronchial Blocker

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 99 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

Javier H Campos
Otherlead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52241, United States

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title: Dr Javier H Campos
Organization: University of Iowa

Study Officials

Javier H Campos, MD
Iowa Health Care
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

50 participants (actual enrollment reported by the registry).

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

Study Record Dates

First Submitted

December 18, 2008

First Posted

December 22, 2008

Study Start

March 2007

Date type not reported

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (2)

Double Lumen Endotracheal Tube

Arndt Bronchial Blocker

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (2)

Double Lumen Endotracheal Tube

Arndt Bronchial Blocker

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations