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

Cancer of the Esophagus Clinical Trial

— Hi-FLO  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04272268
• Other study ID #: 2063
• Secondary ID: 214643
• Status: Withdrawn
• Start date: October 1, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: December 2023
• Source: University Hospitals of North Midlands NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of the Esophagus
• Esophageal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Robert James Bowler	Stoke-on-Trent	Staffordshire

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals of North Midlands NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of respiratory complications within 30 days after surgery	including pneumonia, pleural effusion, adult respiratory distress syndrome and pulmonary embolism.	30 days
Secondary	30 day mortality		30 days
Secondary	90 day mortality		90 days
Secondary	90 day respiratory complication rate		90 days
Secondary	The proportion of blood gases performed on time		5 days
Secondary	The proportion of missing results		5 days
Secondary	Recruitment rate	To facilitate sample size calculation for such a randomized controlled trial.	90 days