NCT04272268

Feasibility and Safety of Using Nasal High Flow Oxygen Postoperatively to Reduce Respiratory Complications

Evaluating the Feasibility and Safety of Using Nasal High Flow Oxygen for Five Days Postoperatively to Reduce Respiratory Complications After Oesophagectomy for Cancer

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: University Hospitals of North Midlands NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The use of nasal high flow in patients undergoing oesophagectomy is a novel technique that has not been previously studied. Nasal high flow will be delivered postoperatively to patients undergoing oesophagectomy in a tertiary cancer referral centre. This single-centre cohort study will evaluate the safety of using nasal high flow in oesophagectomy patients. Physiological parameters, adverse events and clinical outcome will be recorded in consecutive patients undergoing oesophagogastric surgery. This study will challenge the hypothesis that the use of nasal high-flow will lower the rates of breathing complications such as pneumonia thereby reducing the demands on intensive care, shortening hospital stay and improving patient quality of life. The results will inform the design of a larger multicentre clinical trial comparing nasal high flow to conventional methods by facilitating sample size calculation.

Detailed description

Respiratory complications including pneumonia, pleural effusion, adult respiratory distress syndrome and pulmonary embolism will be recorded. The primary endpoint will be the rate of postoperative respiratory complications within 30 days of oesophagectomy. Technical complications related to nasal high flow administration will be recorded and reasons for discontinuing nasal high flow documented. Other outcome including mortality, hospital stay, surgical complications and respiratory complications within 90 days of surgery will be considered as secondary endpoints. These data will assess the feasibility and safety of using nasal high flow in patients undergoing oesophagectomy. The rate of respiratory complications will be determined in a cohort of consecutive surgical patients together with other measures of outcome to form the basis of a series worthy of reporting. This may help gain insight into whether using nasal high flow could benefit patients, and whether further research to compare nasal high flow to conventional respiratory support would be of value.

Conditions

• Cancer of the Esophagus

Interventions

Type	Name	Description
DEVICE	Nasal High flow Oxygen	If the patient is successfully extubated within 4 hours following surgery and meets the post surgery inclusion/exclusion criteria, Nasal high flow oxygen will be administered continuously using a humidifier machine for 5 days. Breathing circuits and nasal cannulae will be connected to the machine to deliver oxygen at 20L/min to the patient.

Timeline

• Start date: 2019-10-01
• Primary completion: 2020-03-31
• Completion: 2020-03-31
• First posted: 2020-02-17
• Last updated: 2024-04-15

Locations

1 site across 1 country: United Kingdom