Back to resultsHigh Flow Nasal Cannula Oxygen During Sedation for Video-assisted Thoracoscopic Surgery
Primary Purpose
Chronic Obstructive Pulmonary Disease, Respiratory Failure
Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
High flow nasal cannula
CONTROL
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria:
- ASA physical status II and III,
- undergoing VATS
Exclusion Criteria:
- refusal of patients
- extrem of age
Sites / Locations
- Rehab Abd Elraof Abd ElazizRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
HFNC group
control group
Arm Description
For HFNC group, F&P AIRVOTM 2 will be adjusted to give the patients the oxygen flow at 50L/min and the FiO2 at 1.0.Then after three minutes of preoxygenation, sedation will be conducted by giving 25 µg fentanyl and a bolus of 1 mg/kg propofol followed by continuous infusion of propofol using a target-controlled infusion system (TCI pump TE371; Terumo Corporation, TokyoJapan).
induction of general anaesthesia will be done using 2 mg/kg propofol and 1 µg/kg fentanyl. Double lumen tube will be facilitated by cisatracurium 0.2 mg/kg. Anaesthesia will be maintained with isoflurane 0.8 %-1% in 100% oxygen and maintenance dose of cisatracurium 0.02 mg/kg when needed. At the end of surgery, residual neuromuscular paralysis will be antagonized with neostigmine 0.05 mg/kg and atropine 0.01 mg/kg.
Outcomes
Primary Outcome Measures
arterial partial pressures of oxygen
an arterial blood sample will be taken after induction of anaesthesia then every 10 min till the end of the operation.
pH measurement
an arterial blood sample will be taken after induction of anaesthesia then every 10 min till the end of the operation.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04520568
Brief Title
High Flow Nasal Cannula Oxygen During Sedation for Video-assisted Thoracoscopic Surgery
Official Title
Preventing Deoxygenation With High Flow Nasal Cannula Oxygen During Sedation for Video-assisted Thoracoscopic Surgery: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
November 10, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
High-flow nasal cannula (HFNC) is a device that delivers10 to 70 L min-1 of heated, humidified 100% oxygen via nasal route. It provides positive airway pressure, decreases dyspnea, decreases the work of breathing, and improves comfort
Detailed Description
Beneficial effects of the HFNC system have been assessed based on 3 physiologic conditions: decreased dead space, a high concentration of inspiratory oxygen, and positive pressure in the oro-laryngeal cavity.Studies have shown that it improves oxygenation in various perioperative settings such as the apneic patients, patients with respiratory failure , and patients undergoing bronchoscopy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Respiratory Failure
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HFNC group
Arm Type
Active Comparator
Arm Description
For HFNC group, F&P AIRVOTM 2 will be adjusted to give the patients the oxygen flow at 50L/min and the FiO2 at 1.0.Then after three minutes of preoxygenation, sedation will be conducted by giving 25 µg fentanyl and a bolus of 1 mg/kg propofol followed by continuous infusion of propofol using a target-controlled infusion system (TCI pump TE371; Terumo Corporation, TokyoJapan).
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
induction of general anaesthesia will be done using 2 mg/kg propofol and 1 µg/kg fentanyl. Double lumen tube will be facilitated by cisatracurium 0.2 mg/kg. Anaesthesia will be maintained with isoflurane 0.8 %-1% in 100% oxygen and maintenance dose of cisatracurium 0.02 mg/kg when needed. At the end of surgery, residual neuromuscular paralysis will be antagonized with neostigmine 0.05 mg/kg and atropine 0.01 mg/kg.
Intervention Type
Combination Product
Intervention Name(s)
High flow nasal cannula
Other Intervention Name(s)
HFNC
Intervention Description
using sedation with the HFNC F&P AIRVOTM 2 to maintain oxygenation
Intervention Type
Combination Product
Intervention Name(s)
CONTROL
Intervention Description
using general anaesthesia with one lung ventilation (OLV) technique
Primary Outcome Measure Information:
Title
arterial partial pressures of oxygen
Description
an arterial blood sample will be taken after induction of anaesthesia then every 10 min till the end of the operation.
Time Frame
two hours
Title
pH measurement
Description
an arterial blood sample will be taken after induction of anaesthesia then every 10 min till the end of the operation.
Time Frame
two hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA physical status II and III,
undergoing VATS
Exclusion Criteria:
refusal of patients
extrem of age
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rehab A. Abd Elaziz, Ass. Prof.
Phone
01001073703
Ext
0
Email
trcium2002@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rehab A. Abd Elaziz, Ass.Prof.
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehab Abd Elraof Abd Elaziz
City
Alexandria
ZIP/Postal Code
000000
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rehab A. Abd Elaziz, Ass. Prof.
Phone
01001073703
Ext
020
Email
trcium2002@yahoo.com
12. IPD Sharing Statement
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High Flow Nasal Cannula Oxygen During Sedation for Video-assisted Thoracoscopic Surgery
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