A Trial Comparing Transnasal humidified Rapid insufflation Ventilatory Exchange (THRIVE) and Apneic Oxygenation With Facemask Ventilation in Elderly Patients Undergoing Induction of Anaesthesia.

NCT03591432 | Unknown

• 1 other identifier: THRIVE-ELDERLY
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Induction of general anaesthesia in patients undergoing emergency surgery can be challenging, because of the often suboptimal circumstances under which anaesthesia has to be delivered, as well as potential physiological derangements caused by their underlying illness, especially in elderly patients. Pre-oxygenation is usually achieved using oxygen delivered via a facemask before induction of anaesthesia. In patients undergoing elective surgery, the lungs are normally ventilated with a bag/facemask technique after induction. However, these options for oxygenation are limited. Facemask ventilation has a perceived risk of gastric insufflation of gas, leading to increased intragastric pressure and raised risk of pulmonary aspiration of stomach contents. Nasal cannulae have been recommended as an alternative method of delivering continuous oxygen during induction of anaesthesia. The Aim of this study is to compare the effect of transnasal humidified rapid insufflation ventilatory exchange (THRIVE) oxygenation with facemask oxygenation on extended apnoeic period and postoperative respiratory complications in elderly patients undergoing induction of anaesthesia.

Conditions

Anesthesia Intubation Complication; Postoperative Complications

Outcome Measures

Primary Outcomes (2)

• Postoperative respiratory complications

  14 days after surgery

• Extended apnoeic period

  during induction of anesthesia

Study Arms (2)

THRIVE

EXPERIMENTAL

Using transnasal humidified rapid insufflation ventilatory exchange (THRIVE) oxygenation technique in elderly patients undergoing induction of anesthesia.

Device: Transnasal humidified rapid insufflation ventilatory exchange (THRIVE)

Facemask

ACTIVE COMPARATOR

Using facemask technique in elderly patients undergoing induction of anesthesia.

Device: Facemask ventilation

Interventions

Transnasal humidified rapid insufflation ventilatory exchange (THRIVE) DEVICE

Transnasal humidified rapid insufflation ventilatory exchange (THRIVE) is a new technique that is available for use in critically ill patients and in patients with difficult airways. The technique combines the benefits of apneic oxygenation and CPAP with a reduction in CO2 levels through gaseous mixing and flushing of the dead space. THRIVE is administered through a standard, commercially available, nasal, high-flow oxygen delivery system. Insufflation of O2 up to 70 L/min via a purpose-made nasal cannula is used initially to provide preoxygenation, which can be continued during intravenous induction until a definitive airway is secured. The THRIVE technique has been demonstrated to appreciably prolong the safe duration of apnea while avoiding increase in CO2.

THRIVE

Facemask ventilation DEVICE

Nowadays pre-oxygenation is usually achieved using oxygen delivered via a facemask before induction of anaesthesia; this potentially extends the time available for securing the airway before hypoxaemia to 6 min. In patients undergoing elective surgery, the lungs are normally ventilated with a bag/facemask technique after induction, and this can be repeated if attempts at intubating the trachea are prolonged.

Facemask

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients who required induction of general anaesthesia for emergency surgery, whose routine clinical care required arterial blood gas sampling, and who were competent to give consent were recruited.

You may not qualify if:

• Patients who had severe respiratory disease.

Sponsors & Collaborators

• Tao Zhang: lead

Study Sites (1)

First Affiliated Hospital, Sun Yat-sen University

Guangzhou, China

Location

Related Publications (3)

• Cook TM, Woodall N, Frerk C; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 1: anaesthesia. Br J Anaesth. 2011 May;106(5):617-31. doi: 10.1093/bja/aer058. Epub 2011 Mar 29.

  PMID: 21447488 BACKGROUND

• Frerk C, Mitchell VS, McNarry AF, Mendonca C, Bhagrath R, Patel A, O'Sullivan EP, Woodall NM, Ahmad I; Difficult Airway Society intubation guidelines working group. Difficult Airway Society 2015 guidelines for management of unanticipated difficult intubation in adults. Br J Anaesth. 2015 Dec;115(6):827-48. doi: 10.1093/bja/aev371. Epub 2015 Nov 10.

  PMID: 26556848 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

MeSH Terms

Conditions

Postoperative Complications

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 7, 2018
• First Posted: July 19, 2018
• Study Start: September 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2020
• Last Updated: July 20, 2018

Record last verified: 2018-07

Locations

CN (1)