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Optimal duration and method of intermittent ventilation to maximize non-hypoxic apnea time during apneic anesthesia with intermittent ventilation technique (AIV) in microlaryngeal surgery: preliminary study

Status Approved

First Submitted Date

2017/06/11
Registered Date

2017/07/21
Last Updated Date

2018/07/26

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0002386
Unique Protocol ID	SMC 2016-06-123
Public/Brief Title	Optimal duration and method of intermittent ventilation to maximize non-hypoxic apnea time during apneic anesthesia for microlaryngeal surgery in infants: preliminary study
Scientific Title	Optimal duration and method of intermittent ventilation to maximize non-hypoxic apnea time during apneic anesthesia with intermittent ventilation technique (AIV) in microlaryngeal surgery: preliminary study
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	SMC 2016-06-123-001
Approval Date	2016-09-19
Institutional Review Board Name	Samsung Medical Center institutional review board
Institutional Review Board Address	81, Ilwon dong, Kangnam gu, Seoul
Institutional Review Board Telephone	02-3410-1847
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Jin Kyung Kim
Title	Professor
Telephone	+82-2-3410-2477
Affiliation	Samsung Medical Center
Address	81, Kangnam gu, Ilwon ro
Contact Person for Public Queries
Name	Sang Hyun Lee
Title	Clinical asso. pf.
Telephone	+82-2-3410-1084
Affiliation	Samsung Medical Center
Address	81, Kangnam gu, Ilwon ro
Contact Person for Updating Information
Name	Sang Hyun Lee
Title	Clinical asso. pf.
Telephone	+82-2-3410-1084
Affiliation	Samsung Medical Center
Address	81, Kangnam gu, Ilwon ro

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Terminated
Date of First Enrollment	2017-05-04 Actual
Target Number of Participant	20
Primary Completion Date
Study Completion Date
Name of Study	Samsung Medical Center
Recruitment Status	Terminated Terminated Reason : 연구대상자가 희소하여 모집이 어려우며, 일차연구목표 (primary end point) 에 도달하기 전에 수술이 조기종료되어, 연구의 일차적인 목표를 잘 반영하지 못할 것으로 사료되어 모집중단합니다.
Date of First Enrollment	2017-05-04 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Samsung Medical Center
Organization Type	Medical Institute
Project ID	SMC 2016-06-123-001

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Samsung Medical Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Apneic anesthesia with intermittent ventilation (AIV) technique is widely used ventilation technique used in microlaryngeal surgery. For successful AIV technique, it is important to oxygenate the patient’s functional residual capacity (FRC) and remove retained CO2 for the subsequent apena period. By providing sufficient ventilation in between apneic period, we can provide adequate non-hypoxic apneic time for surgery. In healthy adults, 8-10 minutes of non hypoxic apnea time may be achieved with adequate prior ventilation with oxygen. However in young infants, they have relatively brief non hypoxic apnea time because of small FRC and high alveolar ventilation. In previous studies, 2 year old infant can tolerate mean duration of 150 seconds for SpO2 to drop < 95% and mean duration of 300 seconds in 3 year old infant. We can use FETO2 > 90% as an indirect measure of adequate oxygenation. In clinical practice we wait for another 1-3 minutes after FETO2 > 90% has been reached during intermittent ventilation. The intermittent ventilation time is longer the better for oxygenation and reducing CO2, however, it is not feasible for it is associated with delay in surgical procedure. Therefore, we decided to investigate firstly, the minimally required intermittent ventilation time to sustain non hypoxic ventilation and secondly, if non hypoxic apnea ventilation time can differ with different PEEP level of mechanical ventilation during intermittent ventilation. (mechanical ventilation technique (a) TV 6 ml/kg, PEEP 4 cmH2O, I:E ratio 1: 1.5, RR 20-30/min versus. (b) TV 6 ml/kg, PEEP 8 cmH2O, I:E ratio 1: 1.5, RR 20-30/min)

Study Summary Information

Lay Summary

Apneic anesthesia with intermittent ventilation (AIV) technique is widely used ventilation technique used in microlaryngeal surgery. For successful AIV technique, it is important to oxygenate the patient’s functional residual capacity (FRC) and remove retained CO2 for the subsequent apena period. By providing sufficient ventilation in between apneic period, we can provide adequate non-hypoxic apneic time for surgery. In healthy adults, 8-10 minutes of non hypoxic apnea time may be achieved with adequate prior ventilation with oxygen. However in young infants, they have relatively brief non hypoxic apnea time because of small FRC and high alveolar ventilation. In previous studies, 2 year old infant can tolerate mean duration of 150 seconds for SpO2 to drop &lt; 95&#37; and mean duration of 300 seconds in 3 year old infant.
We can use FETO2 &gt; 90&#37; as an indirect measure of adequate oxygenation. In clinical practice we wait for another 1-3 minutes after FETO2 &gt; 90&#37; has been reached during intermittent ventilation. The intermittent ventilation time is longer the better for oxygenation and reducing CO2, however, it is not feasible for it is associated with delay in surgical procedure.
Therefore, we decided to investigate firstly, the minimally required intermittent ventilation time to sustain non hypoxic ventilation and secondly, if non hypoxic apnea ventilation time can differ with different PEEP level of mechanical ventilation during intermittent ventilation. (mechanical ventilation technique (a) TV 6 ml/kg, PEEP 4 cmH2O, I:E ratio 1: 1.5, RR 20-30/min versus. (b) TV 6 ml/kg, PEEP 8 cmH2O, I:E ratio 1: 1.5, RR 20-30/min)

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Others (optimal intermittent apneic ventilation technique during microlaryngeal surgery in infant)
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Single
Blinded Subject	Subject
Allocation	RCT
Intervention Type	/Procedure/Surgery
Intervention Description	First part of the study compares the two different intermittent ventilation time to sustain non hypoxic ventilation (intermittent ventilation for 30 seconds versus 60 seconds after achieving FETO2 > 90%) to see if one or the other prolongs non hypoxic ventilation time. Second part of the study compares if non hypoxic apnea ventilation time can differ with different PEEP level of mechanical ventilation during intermittent ventilation. (mechanical ventilation technique (a) TV 6 ml/kg, PEEP 4 cmH2O, I:E ratio 1: 1.5, RR 20-30/min versus. (b) TV 6 ml/kg, PEEP 8 cmH2O, I:E ratio 1: 1.5, RR 20-30/min)
Number of Arms	4
Arm 1	Arm Label for fist study, 30 s group
	Target Number of Participant 5
	Arm Type Experimental
	Arm Description Check time required for FETO2 > 90% after start of ventilation after apnea peroid. Sustain intermittent ventilation time for 30 seconds after reaching FETO2 > 90%, and after extubation, check time to SpO2 98 Also measure nadir saturation
Arm 2	Arm Label for fist study, 60 s group
	Target Number of Participant 5
	Arm Type Experimental
	Arm Description Check time required for FETO2 > 90% after start of ventilation after apnea peroid. Sustain intermittent ventilation time for 60 seconds after reaching FETO2 > 90%, and after extubation, check time to SpO2 98 Also measure nadir saturation
Arm 3	Arm Label for second study, PEEP 4 group
	Target Number of Participant 5
	Arm Type Experimental
	Arm Description Ventilate for 30 seconds during intermittent ventilation in the setting of TV 6 ml/kg, PEEP 4 cmH2O, I:E ratio 1: 1.5, RR 20-30/min, thereafter measure time to SpO2 98% after apnea ventilation (extubation). Also measure nadir saturation
Arm 4	Arm Label for second study, PEEP 8 group
	Target Number of Participant 5
	Arm Type Experimental
	Arm Description Ventilate for 30 seconds during intermittent ventilation in the setting of TV 6 ml/kg, PEEP 8 cmH2O, I:E ratio 1: 1.5, RR 20-30/min, thereafter measure time to SpO2 98% after apnea ventilation (extubation). Also measure nadir saturation

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (J00-J99)Diseases of the respiratory system (J38.3)Other diseases of vocal cords
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 1Month~8Year
	Description 1month to 9 year old patients undergoing elective microlaryngeal surgery
Exclusion Criteria	concomittent cardiac or respiratory diseases with reduced function and /or with tracheal intubated state, allergic to anesthesia, history of CNS diseases or under chronic use of CNS medication, chronic use of analgesics, hemodynamically unstable stuatus
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Not applicable
Outcome	time to SpO2 98%
Timepoint	time to SpO2 98% (for every round of apnea ventilation- can differ for each surgery according to patient)
Secondary Outcome(s) 1
Outcome	nadir SpO2
Timepoint	for every round of apnea ventilation- can differ for each surgery according to patient)

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Not provided at time of Registration

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