Clinical trial NCT04272268: Feasibility and Safety of Using Nasal High Flow Oxygen Postoperatively to Reduce Respiratory Complications
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cancer of the Esophagus
Lead sponsor: University Hospitals of North Midlands NHS Trust
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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

Primary outcomes:
measure: Rate of respiratory complications within 30 days after surgery
timeFrame: 30 days
Secondary outcomes:
measure: 30 day mortality
timeFrame: 30 days
measure: 90 day mortality
timeFrame: 90 days
measure: 90 day respiratory complication rate
timeFrame: 90 days
measure: The proportion of blood gases performed on time
timeFrame: 5 days
measure: The proportion of missing results
timeFrame: 5 days
measure: Recruitment rate
timeFrame: 90 days
Other outcomes:
Locations:
city: Stoke-on-Trent
country: United Kingdom
facility: Robert James Bowler
state: Staffordshire
Study officials:
affiliation: University Hospitals of North Midlands NHS Trust
name: Gerorge Bouras
role: PRINCIPAL_INVESTIGATOR
References: