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Effects of Different Oxygen Concentrations on Pulmonary Complications in Patients Undergoing Radical Resection of Esophageal Cancer (DOICA-E)

Primary Purpose

Atelectasis, Postoperative

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
30%Oxygen
60%Oxygen
Sponsored by
China Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atelectasis, Postoperative

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: American Association of Anesthesiologists (ASA) patients with I-II physical condition; Patients with preoperative partial pressure of blood gas and oxygen greater than 80mmHg who were scheduled for elective esophageal cancer surgery were operated in the right lateral position first and then in the supine position. Exclusion Criteria: there is a history of acute lung injury with acute respiratory distress syndrome within three months; Heart failure (classified by new york Heart Association) is greater than grade IV, there is a serious liver and kidney dysfunction (children with grade B or C liver failure, glomerular filtration rate < 30 ml/min); Body mass index > 30kg/m2; coagulation dysfunction; Patients receiving neoadjuvant chemotherapy; Operation time exceeds 10h The amount of bleeding is more than 800ml, and the total fluid volume is more than 3000ml.

Sites / Locations

  • the First Hospital of China Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental: 30% Oxygen

Experimental: 60% Oxygen

Arm Description

Before anesthesia induction, the participants inhaled pure oxygen through the mask for 5 minuets. After successful anesthesia induction, FiO2 will be adjusted to 60% in one lung ventilation and 30% FIO2 in both lungs ventilation, and the total gas flow rate will be set at 2L/min. All patients will be performed via the lung protective ventilation strategy. The respiratory parameters are VT: 6-8ml/kg, PEEP: 6-8 cm H2O, RR: 1:2. Manual lung recruitment maneuvers will be performed after tracheal intubation and before tracheal extubation, however when intraoperative oxygen saturation is less than 92% the manual lung recruitment maneuver will be done too. Arterial blood will be collected for blood gas analysis. Patients in both groups will be extubation the operating room and then sent to the PACU. patients should transfer to 60% Oxygen group if intraoperative oxygen saturation less than 85%.

Before anesthesia induction, the participants inhaled pure oxygen through the mask for 5 minutes. After successful anesthesia induction, FiO2 will be adjusted to 100% in one lung ventilation and 60% FIO2 in both lungs ventilation, and the total gas flow rate will be set at 2L/min. All patients will be performed via the lung protective ventilation strategy. The respiratory parameters are VT: 6-8ml/kg, PEEP: 6-8 cm H2O, RR: 1:2. Manual lung recruitment maneuvers will be performed after tracheal intubation and before tracheal extubation, however when intraoperative oxygen saturation is less than 92% the manual lung recruitment maneuver will be done too. Arterial blood will be collected for blood gas analysis. Patients in both groups will be extubation the operating room and then sent to the PACU.

Outcomes

Primary Outcome Measures

the occurrence of atelectasis
The primary outcome is the occurrence of atelectasis scanned by computerized tomography in the operating room within 40 minutes after awakening

Secondary Outcome Measures

oxygenation index
The secondary outcome is the comparison of the oxygenation index between the two groups, which is calculated and compared from the results of intraoperative blood gas analysis

Full Information

First Posted
August 22, 2023
Last Updated
August 22, 2023
Sponsor
China Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT06013098
Brief Title
Effects of Different Oxygen Concentrations on Pulmonary Complications in Patients Undergoing Radical Resection of Esophageal Cancer
Acronym
DOICA-E
Official Title
Effects of Different Oxygen Concentrations on Pulmonary Complications in Patients Undergoing Radical Resection of Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Radical operation of esophageal cancer is complicated and traumatic, and ventilation with one lung in lateral position and ventilation with both lungs after supine position requires long-term tracheal intubation and ventilator-assisted ventilation, and the incidence of postoperative pulmonary complications is high.
Detailed Description
Therefore, we should explore the most appropriate lung protection ventilation strategy to reduce the occurrence of pulmonary complications. The recommended standard of international expert group on lung protective ventilation strategy points out that the lowest concentration of oxygen (≤40%) should be inhaled as much as possible during mechanical ventilation to maintain normal blood oxygen level (SpO2≥94%). If the mixed gas with low inhaled oxygen concentration can achieve ideal oxygen saturation and arterial oxygen partial pressure, it may reduce the postoperative pulmonary complications of the subjects. However, there are few reports on the influence of different oxygen concentrations on pulmonary complications in patients undergoing radical resection of esophageal cancer. This study intends to explore the influence of different oxygen concentrations on pulmonary complications in patients undergoing radical resection of esophageal cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atelectasis, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: 30% Oxygen
Arm Type
Experimental
Arm Description
Before anesthesia induction, the participants inhaled pure oxygen through the mask for 5 minuets. After successful anesthesia induction, FiO2 will be adjusted to 60% in one lung ventilation and 30% FIO2 in both lungs ventilation, and the total gas flow rate will be set at 2L/min. All patients will be performed via the lung protective ventilation strategy. The respiratory parameters are VT: 6-8ml/kg, PEEP: 6-8 cm H2O, RR: 1:2. Manual lung recruitment maneuvers will be performed after tracheal intubation and before tracheal extubation, however when intraoperative oxygen saturation is less than 92% the manual lung recruitment maneuver will be done too. Arterial blood will be collected for blood gas analysis. Patients in both groups will be extubation the operating room and then sent to the PACU. patients should transfer to 60% Oxygen group if intraoperative oxygen saturation less than 85%.
Arm Title
Experimental: 60% Oxygen
Arm Type
Placebo Comparator
Arm Description
Before anesthesia induction, the participants inhaled pure oxygen through the mask for 5 minutes. After successful anesthesia induction, FiO2 will be adjusted to 100% in one lung ventilation and 60% FIO2 in both lungs ventilation, and the total gas flow rate will be set at 2L/min. All patients will be performed via the lung protective ventilation strategy. The respiratory parameters are VT: 6-8ml/kg, PEEP: 6-8 cm H2O, RR: 1:2. Manual lung recruitment maneuvers will be performed after tracheal intubation and before tracheal extubation, however when intraoperative oxygen saturation is less than 92% the manual lung recruitment maneuver will be done too. Arterial blood will be collected for blood gas analysis. Patients in both groups will be extubation the operating room and then sent to the PACU.
Intervention Type
Drug
Intervention Name(s)
30%Oxygen
Intervention Description
60%FiO2 in one lung ventilation and 30% FIO2 in both lungs ventilation
Intervention Type
Drug
Intervention Name(s)
60%Oxygen
Intervention Description
100%FiO2 in one lung ventilation and 60% FIO2 in both lungs ventilation
Primary Outcome Measure Information:
Title
the occurrence of atelectasis
Description
The primary outcome is the occurrence of atelectasis scanned by computerized tomography in the operating room within 40 minutes after awakening
Time Frame
On the operating room within 40 minutes after awakening
Secondary Outcome Measure Information:
Title
oxygenation index
Description
The secondary outcome is the comparison of the oxygenation index between the two groups, which is calculated and compared from the results of intraoperative blood gas analysis
Time Frame
On the operating room within 40 minutes after awakening

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Association of Anesthesiologists (ASA) patients with I-II physical condition; Patients with preoperative partial pressure of blood gas and oxygen greater than 80mmHg who were scheduled for elective esophageal cancer surgery were operated in the right lateral position first and then in the supine position. Exclusion Criteria: there is a history of acute lung injury with acute respiratory distress syndrome within three months; Heart failure (classified by new york Heart Association) is greater than grade IV, there is a serious liver and kidney dysfunction (children with grade B or C liver failure, glomerular filtration rate < 30 ml/min); Body mass index > 30kg/m2; coagulation dysfunction; Patients receiving neoadjuvant chemotherapy; Operation time exceeds 10h The amount of bleeding is more than 800ml, and the total fluid volume is more than 3000ml.
Facility Information:
Facility Name
the First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenfei Tan, M.D.,Ph.D
Phone
024-83283100
Email
winfieldtan@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Effects of Different Oxygen Concentrations on Pulmonary Complications in Patients Undergoing Radical Resection of Esophageal Cancer

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