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

NCT ID: NCT04272268

Last Updated: 2024-04-15

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2020-03-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Nasal High flow Oxygen

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.

Nasal High flow Oxygen

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospitals of North Midlands NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerorge Bouras

Role: PRINCIPAL_INVESTIGATOR

University Hospitals of North Midlands NHS Trust

Locations

Robert James Bowler

Stoke-on-Trent, Staffordshire, United Kingdom

Countries

United Kingdom

Other Identifiers

214643

Identifier Type: OTHER

Identifier Source: secondary_id

2063

Identifier Type: -

Identifier Source: org_study_id