Airvo/Optiflow High Flow Nasal Oxygenation During Microlaryngeal Surgery

NCT02780518 | Withdrawn

• 1 other identifier: 1605 Airvo Optiflow
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Optiflow high flow nasal cannula (HFNC) oxygenation is a technique to provide oxygen to patients when they are paralysed under general anaesthesia. Their lungs are not moving, but the high flow allows oxygen to travel into their lungs. This is called 'apnoeic ventilation'. The investigators will be using this for patients undergoing surgery for their throat.

Conditions

Throat Disorders

Keywords

oxygen; carbon dioxide

Outcome Measures

Primary Outcomes (1)

• Number of patients with inadequate oxygenation as measured by pulse oximetry (SpO2<94%).

  Continuous pulse oximetry will be monitored for participants during the study.

  30 minutes

Secondary Outcomes (2)

• Number of patients with inadequate carbon dioxide clearance (end tidal CO2>55 mmHg)

  30 minutes

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.03

  30 minutes

Study Arms (1)

Airvo

EXPERIMENTAL

All patients scheduled for elective microlaryngeal surgery under general anaesthesia and subglottic high frequency jet ventilation

Device: Airvo

Interventions

Airvo DEVICE

Applying high flow nasal oxygen

Airvo

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients undergoing elective microlaryngeal surgery requiring general anaesthesia and jet ventilation. They must have a physical status of the American Society of Anesthesiologists (ASA) grade I/II and age 21 years or older.

You may not qualify if:

• Patients with history of previous difficult endotracheal intubation
• Patients with two or more predictors of difficult mask ventilation or difficult intubation or the combination of both
• Patients with ASA grading of III and above are excluded from the study
• Patients needing a rapid sequence induction for rapid securement of the airway
• Pregnant women
• Patients below the age of 21 years old
• Patients unfit to give consent
• Patients with nasal or sinus disease or problems
• Patients with infective laryngeal disease e.g. papillomatosis

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

Related Publications (2)

• Patel A, Nouraei SA. Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE): a physiological method of increasing apnoea time in patients with difficult airways. Anaesthesia. 2015 Mar;70(3):323-9. doi: 10.1111/anae.12923. Epub 2014 Nov 10.

  PMID: 25388828 BACKGROUND

• Nishimura M. High-flow nasal cannula oxygen therapy in adults. J Intensive Care. 2015 Mar 31;3(1):15. doi: 10.1186/s40560-015-0084-5. eCollection 2015.

  PMID: 25866645 BACKGROUND

Study Officials

• Patrick Wong, MBBS FRCA

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: May 23, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: May 1, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)