Clinical trial NCT03816748: The Efficacy of Postoperative Application of HFNC at Acute Phase for Minimally Invasive Esophagectomy Surgery Patients
Official title: The Efficacy of Postoperative Application of High Flow Nasal Cannula at Acute Phase for Minimally Invasive Esophagectomy Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Cancer
Keywords: Minimally invasive surgery
High flow nasal cannula
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 69
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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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Primary outcomes:
measure: Oxygenation
timeFrame: Post-operative 24 hours - 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: HSIEN-CHI LIAO, M.D.
role: STUDY_DIRECTOR
References: