High Flow Nasal Cannula Oxygen During Sedation for Video-assisted Thoracoscopic Surgery

NCT ID: NCT04520568

Last Updated: 2020-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2020-12-01

Brief Summary

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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

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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

Conditions

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Chronic Obstructive Pulmonary Disease Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

High flow nasal cannula

Intervention Type COMBINATION_PRODUCT

using sedation with the HFNC F\&P AIRVOTM 2 to maintain oxygenation

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.

Group Type PLACEBO_COMPARATOR

CONTROL

Intervention Type COMBINATION_PRODUCT

using general anaesthesia with one lung ventilation (OLV) technique

Interventions

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High flow nasal cannula

using sedation with the HFNC F\&P AIRVOTM 2 to maintain oxygenation

Intervention Type COMBINATION_PRODUCT

CONTROL

using general anaesthesia with one lung ventilation (OLV) technique

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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HFNC

Eligibility Criteria

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Inclusion Criteria

* ASA physical status II and III,
* undergoing VATS

Exclusion Criteria

* refusal of patients
* extrem of age
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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rehab zayed

Assisstant Professor of Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rehab A. Abd Elaziz, Ass.Prof.

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Locations

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Rehab Abd Elraof Abd Elaziz

Alexandria, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Rehab A. Abd Elaziz, Ass. Prof.

Role: CONTACT

01001073703 ext. 0

Facility Contacts

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Rehab A. Abd Elaziz, Ass. Prof.

Role: primary

01001073703 ext. 020

Other Identifiers

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0304712

Identifier Type: -

Identifier Source: org_study_id

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