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

NCT04272268 | Withdrawn

• 2 other identifiers: 2063214643
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer of the Esophagus

Outcome Measures

Primary Outcomes (1)

• Rate of respiratory complications within 30 days after surgery

  including pneumonia, pleural effusion, adult respiratory distress syndrome and pulmonary embolism.

  30 days

Secondary Outcomes (6)

• 30 day mortality

  30 days

• 90 day mortality

  90 days

• 90 day respiratory complication rate

  90 days

• The proportion of blood gases performed on time

  5 days

• The proportion of missing results

  5 days

Study Arms (1)

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.

Device: Nasal High flow Oxygen

Interventions

Nasal High flow Oxygen 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.

Nasal High flow Oxygen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals of North Midlands NHS Trust: lead

Study Sites (1)

Robert James Bowler

Stoke-on-Trent, Staffordshire, ST44JJ, United Kingdom

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Gerorge Bouras

  University Hospitals of North Midlands NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 17, 2020
• Study Start: October 1, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: April 15, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)