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

NCT ID: NCT03591432

Last Updated: 2018-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-30
• Study Completion Date: 2020-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

THRIVE

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

Group Type: EXPERIMENTAL

Transnasal humidified rapid insufflation ventilatory exchange (THRIVE)

Intervention Type: 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.

Facemask

Using facemask technique in elderly patients undergoing induction of anesthesia.

Group Type: ACTIVE_COMPARATOR

Facemask ventilation

Intervention Type: 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.

Interventions

Transnasal humidified rapid insufflation ventilatory exchange (THRIVE)

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.

Intervention Type: DEVICE

Facemask ventilation

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Patients who had severe respiratory disease.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tao Zhang

OTHER

Sponsor Role: lead

Responsible Party

Tao Zhang

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

First Affiliated Hospital, Sun Yat-sen University

Guangzhou, , China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 21447488 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26556848 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25866645 (View on PubMed)

Other Identifiers

THRIVE-ELDERLY

Identifier Type: -

Identifier Source: org_study_id