search
Back to results

Pulmonary Mechanics During Minimally Invasive Repair of Pectus Excavatum

Primary Purpose

Pectus Excavatum

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Desflurane
Sevoflurane
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pectus Excavatum focused on measuring respiratory resistance, lung compliance, desflurane, sevoflurane

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • clinical diagnosis of Pectus Excavatum
  • undergoing minimally invasive repair

Exclusion Criteria:

  • younger than 15 year old
  • history of upper respiratory tract infection within recent 2 weeks
  • asthma
  • chronic obstructive pulmonary disease
  • previous treatment with bronchoactive drugs (B-agonist or antagonist, theophyline, anticholinergics and corticosteroid)
  • history of neurological deficits

Sites / Locations

  • Seoul St. Mary's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

sevoflurane

Desflurane

Arm Description

Anesthesia with sevoflurane

Anesthesia with desflurane

Outcomes

Primary Outcome Measures

pulmonary mechanics
respiratory resistance dynamic and static lung compliance

Secondary Outcome Measures

complication
bronchospasm dyspnea pneumothorax

Full Information

First Posted
November 26, 2011
Last Updated
July 22, 2013
Sponsor
The Catholic University of Korea
search

1. Study Identification

Unique Protocol Identification Number
NCT01486953
Brief Title
Pulmonary Mechanics During Minimally Invasive Repair of Pectus Excavatum
Official Title
Phase 4 Study of Desflurane and Sevoflurane That Affect Pulmonary Mechanics During Minimally Invasive Repair of Pectus Excavatum
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
April 2014 (Anticipated)
Study Completion Date
April 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the current study was to compare the effects of sevoflurane and desflurane on respiratory mechanics in patients undergoing repair of pectus excavatum.
Detailed Description
The minimally invasive technique for pectus excavatum repair was introduced by Nuss and colleagues using a metal bar to lift the depressed chest wall. This surgical procedure is usually done under general anesthesia with tracheal intubation. After inserting metal bar into the chest wall, decreased lung compliance was shown. Previous studies demonstrated that administering desflurane during anesthesia resulted in marked increases in respiratory mechanical parameters, especially in the children with airway susceptibility. Our primary hypothesis was that desflurane would cause an increase in respiratory resistance and a decrease in lung compliance compared to sevoflurane during repair of pectus excavatum.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pectus Excavatum
Keywords
respiratory resistance, lung compliance, desflurane, sevoflurane

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sevoflurane
Arm Type
Active Comparator
Arm Description
Anesthesia with sevoflurane
Arm Title
Desflurane
Arm Type
Experimental
Arm Description
Anesthesia with desflurane
Intervention Type
Drug
Intervention Name(s)
Desflurane
Intervention Description
Using random numbers, patients were divided into two groups to receive either sevoflurane or desflurane. After induction of anesthesia and intubation, the patient's lungs were ventilated in constant-flow VCV mode by an anesthetic Ventilator (Datex-Ohmeda, GE healthcare, Finland). Ventilator settings were tidal volume 10 ml/kg, inspiratory:expiratory (I:E) ratio 1:1.5, inspired oxygen concentration (FiO2) 0.5 with air, and 3 L/min of inspiratory fresh gas flow. End-inspiratory pause was set 20% of total breathing cycle. Positive end-expiratory pressure (PEEP) was not used. Respiratory rate was adjusted to maintain an end-tidal CO2 pressure of 33-35 mmHg. Patients received desflurane 6-7% for maintenance of anesthesia.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
Using random numbers, patients were divided into two groups to receive either sevoflurane or desflurane. After induction of anesthesia and intubation, the patient's lungs were ventilated in constant-flow VCV mode by an anesthetic Ventilator (Datex-Ohmeda, GE healthcare, Finland). Ventilator settings were tidal volume 10 ml/kg, inspiratory:expiratory (I:E) ratio 1:1.5, inspired oxygen concentration (FiO2) 0.5 with air, and 3 L/min of inspiratory fresh gas flow. End-inspiratory pause was set 20% of total breathing cycle. Positive end-expiratory pressure (PEEP) was not used. Respiratory rate was adjusted to maintain an end-tidal CO2 pressure of 33-35 mmHg. Patients received sevoflurane 2-2.5% for maintenance of anesthesia.
Primary Outcome Measure Information:
Title
pulmonary mechanics
Description
respiratory resistance dynamic and static lung compliance
Time Frame
within the 2 hours during the surgery
Secondary Outcome Measure Information:
Title
complication
Description
bronchospasm dyspnea pneumothorax
Time Frame
within 72 hours after sugery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: clinical diagnosis of Pectus Excavatum undergoing minimally invasive repair Exclusion Criteria: younger than 15 year old history of upper respiratory tract infection within recent 2 weeks asthma chronic obstructive pulmonary disease previous treatment with bronchoactive drugs (B-agonist or antagonist, theophyline, anticholinergics and corticosteroid) history of neurological deficits
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeong Eun Kim, M.D, Ph.D
Phone
82-2-2258-6163
Email
moroo0201@catholic.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong Eun Kim, M.D, Ph.D
Organizational Affiliation
Department of Anesthesiology, The Catholic University of Korea, Seoul St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
137-040
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeong Eun Kim, M.D, Ph.D
Phone
82-2-2258-6163
Email
moroo0201@gmail.com
First Name & Middle Initial & Last Name & Degree
Jeong Eun Kim, M.D, Ph.D

12. IPD Sharing Statement

Learn more about this trial

Pulmonary Mechanics During Minimally Invasive Repair of Pectus Excavatum

We'll reach out to this number within 24 hrs