Feasibility and Safety of Using Nasal High Flow Oxygen Postoperatively to Reduce Respiratory Complications (Hi-FLO)

University Hospitals of North Midlands NHS Trust

Status: Withdrawn

Conditions: Cancer of the Esophagus

Treatments: Device: Nasal High flow Oxygen

Study type: Observational

Funder types: Other

Identifiers

NCT04272268

214643 (Other Identifier)

2063

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Over 18 years old
• Undergoing Ivor-Lewis (2-stage) oesophagectomy
• Successfully extubated within 4 hours after surgery

Exclusion criteria

• History of bullous emphysematous disease
• Lack of capacity to consent
• Significant air leak during surgery
• Incurable disease found at surgery leading to no surgical resection
• Failure of extubation and spontaneous breathing within 4 hours after surgery

Trial design

0 participants in 1 patient group

Nasal High flow Oxygen

Description:

Following consent, the participant will undergo Oesophagectomy as per routine care. During surgery, prior to trial participation and as per standard of care at the site, a nasogastric tube will be placed into the gastric conduit and secured to the nose. This tube will be left on free drainage and aspirated every 4 hours to check for inadvertent insufflation.

Treatment:

Device: Nasal High flow Oxygen