High Flow Nasal Cannula Oxygen During Sedation for Video-assisted Thoracoscopic Surgery
Preventing Deoxygenation With High Flow Nasal Cannula Oxygen During Sedation for Video-assisted Thoracoscopic Surgery: A Randomized Controlled Trial
1 other identifier
interventional
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 chronic-obstructive-pulmonary-disease
Started Aug 2020
Shorter than P25 for phase_2 chronic-obstructive-pulmonary-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2020
CompletedFirst Submitted
Initial submission to the registry
August 16, 2020
CompletedFirst Posted
Study publicly available on registry
August 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedAugust 20, 2020
August 1, 2020
3 months
August 16, 2020
August 19, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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.
two hours
pH measurement
an arterial blood sample will be taken after induction of anaesthesia then every 10 min till the end of the operation.
two hours
Study Arms (2)
HFNC group
ACTIVE COMPARATORFor 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).
control group
PLACEBO COMPARATORinduction 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.
Interventions
using sedation with the HFNC F\&P AIRVOTM 2 to maintain oxygenation
using general anaesthesia with one lung ventilation (OLV) technique
Eligibility Criteria
You may qualify if:
- ASA physical status II and III,
- undergoing VATS
You may not qualify if:
- refusal of patients
- extrem of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rehab Abd Elraof Abd Elaziz
Alexandria, 000000, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rehab A. Abd Elaziz, Ass.Prof.
Alexandria University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assisstant Professor of Anesthesia
Study Record Dates
First Submitted
August 16, 2020
First Posted
August 20, 2020
Study Start
August 1, 2020
Primary Completion
November 10, 2020
Study Completion
December 1, 2020
Last Updated
August 20, 2020
Record last verified: 2020-08