The Efficacy of Postoperative Application of HFNC at Acute Phase for Minimally Invasive Esophagectomy Surgery Patients

NCT03816748 | Completed DMC

• 1 other identifier: 201807098RINC
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective study that uses the treatment guideline of our chest surgery ICU. Investigators recruited 90 patients who underwent MIE in the National Taiwan University Hospital. The clinical data collected included vital signs (blood pressure, heart rate, respiratory patterns and frequencies, saturation of blood oxygen and carbon dioxide, etc.), blood tests, images and bronchoscopic analysis of sputum. The goal of this study is to analyze common care problems and complications patients may encounter during the acute stage in ICU after MIE. By comparing the differences between the treatment group and the control group, investigators can interpret the role of HFNC.

Conditions

Esophageal Cancer

Keywords

Minimally invasive surgery; High flow nasal cannula

Outcome Measures

Primary Outcomes (1)

• Oxygenation

  saturation of blood oxygen and carbon dioxide by blood gas analyzer

  Post-operative 24 hours - 72 hours

Study Arms (2)

intervention

EXPERIMENTAL

Patients who underwent minimally invasive esophagectomy surgery in our hospital and transfer to intensive care unit, and accept HFNC treatment

Device: High flow nasal cannula, HFNC

control

NO INTERVENTION

Patients who underwent minimally invasive esophagectomy surgery in our hospital and transfer to intensive care unit, and accept usual care

Interventions

High flow nasal cannula, HFNC DEVICE

The HFNC used in this study can supply more than 40-60 L/min of oxygen flow, which is many times higher than the traditional nasal cannula. In addition, HFNC provides heating and moisturizing functions, so the patients 'nasal and oropharyngeal cavities do not dry out. This way, the patients can wear HFNC continuously for many days. Furthermore, when the patients close their mouths, HFNC can create a PEEP of 6-8 cmH2O, which helps with lung expansion after chest surgeries and lowers the risk of pneumonia related to lung collapses.

intervention

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of esophageal cancer. Underwent minimally invasive esophagectomy surgery.

You may not qualify if:

• \. The patient return to the intensive care unit without extubation 2. The patient who underwent tracheostomy surgery 3. Blood loss more than 1000c.c during the surgery 4. The patient who underwent CPR procedure or other emergent resuscitation management during surgery 5. The patient who is unable to communicate in words or speech

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 10048, Taiwan

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

• HSIEN-CHI LIAO, M.D.

  National Taiwan University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: January 25, 2019
• Study Start: January 1, 2019
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2021
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)