- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04520568
High Flow Nasal Cannula Oxygen During Sedation for Video-assisted Thoracoscopic Surgery
August 19, 2020 updated by: rehab zayed, Alexandria University
Preventing Deoxygenation With High Flow Nasal Cannula Oxygen During Sedation for Video-assisted Thoracoscopic Surgery: A Randomized Controlled Trial
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
Study Overview
Status
Unknown
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Alexandria, Egypt, 000000
- Recruiting
- Rehab Abd Elraof Abd Elaziz
-
Contact:
- Rehab A. Abd Elaziz, Ass. Prof.
- Phone Number: 020 01001073703
- Email: trcium2002@yahoo.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ASA physical status II and III,
- undergoing VATS
Exclusion Criteria:
- refusal of patients
- extrem of age
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: HFNC group
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).
|
using sedation with the HFNC F&P AIRVOTM 2 to maintain oxygenation
Other Names:
|
Placebo Comparator: control group
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.
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using general anaesthesia with one lung ventilation (OLV) technique
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
arterial partial pressures of oxygen
Time Frame: two hours
|
an arterial blood sample will be taken after induction of anaesthesia then every 10 min till the end of the operation.
|
two hours
|
pH measurement
Time Frame: two hours
|
an arterial blood sample will be taken after induction of anaesthesia then every 10 min till the end of the operation.
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two hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2020
Primary Completion (Anticipated)
November 10, 2020
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
August 16, 2020
First Submitted That Met QC Criteria
August 19, 2020
First Posted (Actual)
August 20, 2020
Study Record Updates
Last Update Posted (Actual)
August 20, 2020
Last Update Submitted That Met QC Criteria
August 19, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0304712
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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