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

The Efficacy of Postoperative Application of High Flow Nasal Cannula at Acute Phase for Minimally Invasive Esophagectomy Surgery Patients

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.

Study Overview

• Status: Completed
• Conditions: Esophageal Cancer
• Intervention / Treatment: Device: High flow nasal cannula, HFNC

Detailed Description

In recent years, for resectable esophageal cancer lesions, the National Taiwan University Hospital has developed MIE from the traditional open-abdomen and open-chest reconstructive surgeries. Because the wounds of minimally invasive surgeries are smaller, most of the patients can be extubated soon in the operation rooms. During the period when the patients are sent to ICU for observation, they do not need endotracheal tubes for positive pressure or sputum suction. Thus, high standards are needed for the inspections of post-operative chest care, depth of respiration and ability of expectoration in these patients.

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.

This is a prospective study that uses the treatment guideline of our chest surgery ICU. Investigators recruited 60 patients who underwent MIE in the National Taiwan University Hospital between January 2018 and December 2018. 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.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 10048
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. 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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: intervention; 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; 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.
NO_INTERVENTION: control; Patients who underwent minimally invasive esophagectomy surgery in our hospital and transfer to intensive care unit, and accept usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygenation	saturation of blood oxygen and carbon dioxide by blood gas analyzer	Post-operative 24 hours - 72 hours

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Study Director: HSIEN-CHI LIAO, M.D., National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ACTUAL): November 30, 2020
• Study Completion (ACTUAL): November 30, 2021

Study Registration Dates

• First Submitted: January 23, 2019
• First Submitted That Met QC Criteria: January 23, 2019
• First Posted (ACTUAL): January 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 27, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: High flow nasal cannula; Minimally invasive surgery
• Other Study ID Numbers: 201807098RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No