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

Sponsors

Lead Sponsor: Alexandria University

Source Alexandria University
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

Overall Status Recruiting
Start Date August 1, 2020
Completion Date December 1, 2020
Primary Completion Date November 10, 2020
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
arterial partial pressures of oxygen two hours
pH measurement two hours
Enrollment 60
Condition
Intervention

Intervention Type: Combination Product

Intervention Name: High flow nasal cannula

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

Arm Group Label: HFNC group

Other Name: HFNC

Intervention Type: Combination Product

Intervention Name: CONTROL

Description: using general anaesthesia with one lung ventilation (OLV) technique

Arm Group Label: control group

Eligibility

Criteria:

Inclusion Criteria:

- ASA physical status II and III,

- undergoing VATS

Exclusion Criteria:

- refusal of patients

- extrem of age

Gender: All

Minimum Age: 30 Years

Maximum Age: 70 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Rehab A. Abd Elaziz, Ass.Prof. Principal Investigator Alexandria University
Overall Contact

Last Name: Rehab A. Abd Elaziz, Ass. Prof.

Phone: 01001073703

Phone Ext.: 0

Email: [email protected]

Location
Facility: Status: Contact: Rehab Abd Elraof Abd Elaziz Rehab A. Abd Elaziz, Ass. Prof. 01001073703 020 [email protected]
Location Countries

Egypt

Verification Date

August 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Alexandria University

Investigator Full Name: rehab zayed

Investigator Title: Assisstant Professor of Anesthesia

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: HFNC group

Type: Active Comparator

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).

Label: control group

Type: Placebo Comparator

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.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Diagnostic

Masking: Single (Participant)

Source: ClinicalTrials.gov