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
About this trial
This is an interventional supportive care trial for Pectus Excavatum focused on measuring respiratory resistance, lung compliance, desflurane, sevoflurane
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
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
NCT ID
NCT01486953
First Posted
November 26, 2011
Last Updated
July 22, 2013
Sponsor
The Catholic University of Korea
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
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Pulmonary Mechanics During Minimally Invasive Repair of Pectus Excavatum
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