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HFNO Improves Blood Oxygen Saturation During Asphyxia During Pulmonary Surgery With Double-lumen Endotracheal Intubation

Primary Purpose

Lung Neoplasms, Pneumothorax

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HFNO
Sponsored by
Shenzhen Second People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Neoplasms

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18-60; Patients planning to undergo video-assisted thoracoscopic (VATS) lung surgery requiring DLT intubation; Patients who agreed to participate in this study. Exclusion Criteria: American Society of Anesthesiologists (ASA) classification > IV; Patients with severe nasal obstruction; expected difficult intubation or difficulty with mask ventilation; Morbid obesity [Body Mass Index (BMI)>35kg/m2)]; Airway anatomical abnormalities; Abnormal coagulation function; Emergency surgery; Patients at high risk of reflux aspiration, including ileus, full stomach, esophageal reflux disease; Pregnant or breastfeeding women.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    HFNO group

    Control group

    Arm Description

    Direct guidance and positioning of DLT intubation with FOB visualization, using HFNO during intubation asphyxia.

    The DLT cannula was directly guided and positioned under FOB visualization, and no oxygen therapy equipment was used during intubation.

    Outcomes

    Primary Outcome Measures

    Minimum blood oxygen saturation (SpO2)
    Minimum SpO2 measured by capillary oximeter during DLT intubation. SpO2 was continuously monitored by the monitor every 1 second and recorded every 5 seconds, and the lowest SpO2 was recorded through the monitor by the recording personnel who were not involved in anesthesia management.

    Secondary Outcome Measures

    The incidence of lowest SpO2<90%
    Minimum SpO2 measured by capillary oximeter during DLT intubation. SpO2 was continuously monitored by the monitor every 1 second and recorded every 5 seconds, and the lowest SpO2 was recorded through the monitor by the recording personnel who were not involved in anesthesia management.
    The incidence of lowest SpO2<95%
    Minimum SpO2 measured by capillary oximeter during DLT intubation. SpO2 was continuously monitored by the monitor every 1 second and recorded every 5 seconds, and the lowest SpO2 was recorded through the monitor by the recording personnel who were not involved in anesthesia management.
    DLT intubation time
    The DLT intubation period was defined as: from the time the video laryngoscope was placed in the oral cavity, to the confirmation of the correct position of the DLT by the FOB, and the end of the insertion of the anesthesia machine.
    End-tidal carbon dioxide partial pressure after intubation
    When the tracheal intubation is completed, the monitor displays the partial pressure of carbon dioxide at the end of the first mechanical ventilation.
    End-tidal oxygen concentration after intubation
    When the tracheal intubation is completed, the monitor displays the end-expiratory oxygen concentration of the first mechanical ventilation.
    The incidence of difficult airway
    Difficult airway was defined as failure of videolaryngoscope intubation, switch to fiberoptic bronchoscope-guided intubation.
    The incidence of bronchial dislocation
    Left or right bronchial tube strayed into right or left bronchus.
    Incidence of related complications during intubation
    Associated complications during intubation include: reflux aspiration, laryngospasm or bronchospasm, tracheal or bronchial tear, barotrauma, systolic blood pressure < 90 mmHg or initiation of vasoactive drugs, systolic blood pressure > 180 mmHg, severe arrhythmias, and lips or tooth damage.
    Operator satisfaction with intubation
    Operator satisfaction rating for intubation (range 0-10, with 0 being very dissatisfied and 10 being very satisfied).
    The incidence of low blood oxygen saturation (SpO2<90%) in the post-anaesthesia care unit (PACU)
    After the patient entered the PACU, the blood oxygen saturation was continuously monitored and the lowest blood oxygen saturation value was recorded.
    The incidence of postoperative airway-related complications
    Postoperative airway-related complications include: sore throat, hoarseness, and nasopharyngeal dryness.
    The incidence of nausea and vomiting
    Interview patients' subjective feelings, including nausea and vomiting.
    Patient satisfaction with anesthesia
    Patient satisfaction with anesthesia(range 0-10, with 0 being very dissatisfied and 10 being very satisfied).
    Postoperative hospital stay
    The medical record system queries the number of days in hospital after surgery.
    The incidence of postoperative complication
    Postoperative complications included postoperative atelectasis, pneumothorax, pulmonary infection, pleural effusion, bronchopleural fistula and postoperative bleeding.

    Full Information

    First Posted
    September 21, 2022
    Last Updated
    December 23, 2022
    Sponsor
    Shenzhen Second People's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05666908
    Brief Title
    HFNO Improves Blood Oxygen Saturation During Asphyxia During Pulmonary Surgery With Double-lumen Endotracheal Intubation
    Official Title
    High-flow Nasal Oxygenation Improves Blood Oxygen Saturation During Asphyxia During Pulmonary Surgery With Double-lumen Endotracheal Intubation: a Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shenzhen Second People's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    With the continuous strengthening of the concept of rapid rehabilitation, great progress has been made in minimally invasive thoracic surgery, and thoracoscopic surgery has developed rapidly. Double-lumen endotracheal(DLT) intubation is still the most reliable way of intubation in lung surgery. However, hypoxemia faced during double-lumen intubation still threatens the perioperative safety of thoracic surgery patients. In recent years, high-flow nasal oxygenation (HFNO) has great potential in the field of anesthesia, especially playing a new and important role in the prevention and treatment of short-term hypoxia and life-threatening airway emergencies. However, the use of HFNO in pulmonary surgery patients with poor pulmonary function lacks evidence-based basis, and there are few reliable clinical data. This study adopted a prospective, randomized, controlled, single-blind design. A total of 100 patients aged 18-60 years who underwent elective thoracoscopy-assisted pulmonary surgery were included and randomly divided into the experimental group: HFNO was used in the process of double-lumen intubation asphyxia; the control group: according to the traditional intubation process, No oxygen therapy equipment was used during intubation asphyxiation. The lowest blood oxygen saturation during intubation, the incidence of hypoxemia during intubation, perioperative complications, and postoperative hospital stay were compared between the two groups. This study explores the advantages of HFNO in complex endotracheal intubation, assuming that HFNO can improve the oxygen saturation of double-lumen intubation; optimize the intubation method of DLT, and tap its new potential to prevent and manage emergency airway crisis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Neoplasms, Pneumothorax

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    112 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    HFNO group
    Arm Type
    Experimental
    Arm Description
    Direct guidance and positioning of DLT intubation with FOB visualization, using HFNO during intubation asphyxia.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    The DLT cannula was directly guided and positioned under FOB visualization, and no oxygen therapy equipment was used during intubation.
    Intervention Type
    Device
    Intervention Name(s)
    HFNO
    Other Intervention Name(s)
    high flow nasal oxygen therapy
    Intervention Description
    After the patient's mask-assisted ventilation makes the end-expiratory oxygen concentration (EtO2) > 90%, wear the HFNO device according to the pre-adjusted mode (temperature 34°C, oxygen concentration 100%, flow rate 50 litres per minute). The nasal cannula will remain in place until intubation is complete (including DLT intubation, direct FOB guidance, and DLT alignment with FOB). After securing the HFNO device, the glottis was exposed using a laryngoscope, and the DLT main tracheal cuff was passed through the glottis and paused under direct vision. Insert the DLT into the bronchial tube lumen of the DLT using the FOB, and then advance the DLT into the corresponding main bronchus under the guidance of the FOB. After confirming the appropriate depth of the catheter using the FOB, insert the DLT into the anesthesia machine to complete the intubation process. After the DLT was connected to the anesthesia machine and mechanical ventilation was started, the HFNO device was removed.
    Primary Outcome Measure Information:
    Title
    Minimum blood oxygen saturation (SpO2)
    Description
    Minimum SpO2 measured by capillary oximeter during DLT intubation. SpO2 was continuously monitored by the monitor every 1 second and recorded every 5 seconds, and the lowest SpO2 was recorded through the monitor by the recording personnel who were not involved in anesthesia management.
    Time Frame
    After the DLT intubation
    Secondary Outcome Measure Information:
    Title
    The incidence of lowest SpO2<90%
    Description
    Minimum SpO2 measured by capillary oximeter during DLT intubation. SpO2 was continuously monitored by the monitor every 1 second and recorded every 5 seconds, and the lowest SpO2 was recorded through the monitor by the recording personnel who were not involved in anesthesia management.
    Time Frame
    After the DLT intubation
    Title
    The incidence of lowest SpO2<95%
    Description
    Minimum SpO2 measured by capillary oximeter during DLT intubation. SpO2 was continuously monitored by the monitor every 1 second and recorded every 5 seconds, and the lowest SpO2 was recorded through the monitor by the recording personnel who were not involved in anesthesia management.
    Time Frame
    After the DLT intubation
    Title
    DLT intubation time
    Description
    The DLT intubation period was defined as: from the time the video laryngoscope was placed in the oral cavity, to the confirmation of the correct position of the DLT by the FOB, and the end of the insertion of the anesthesia machine.
    Time Frame
    After the DLT intubation
    Title
    End-tidal carbon dioxide partial pressure after intubation
    Description
    When the tracheal intubation is completed, the monitor displays the partial pressure of carbon dioxide at the end of the first mechanical ventilation.
    Time Frame
    After the DLT intubation
    Title
    End-tidal oxygen concentration after intubation
    Description
    When the tracheal intubation is completed, the monitor displays the end-expiratory oxygen concentration of the first mechanical ventilation.
    Time Frame
    After the DLT intubation
    Title
    The incidence of difficult airway
    Description
    Difficult airway was defined as failure of videolaryngoscope intubation, switch to fiberoptic bronchoscope-guided intubation.
    Time Frame
    After the DLT intubation
    Title
    The incidence of bronchial dislocation
    Description
    Left or right bronchial tube strayed into right or left bronchus.
    Time Frame
    After the DLT intubation
    Title
    Incidence of related complications during intubation
    Description
    Associated complications during intubation include: reflux aspiration, laryngospasm or bronchospasm, tracheal or bronchial tear, barotrauma, systolic blood pressure < 90 mmHg or initiation of vasoactive drugs, systolic blood pressure > 180 mmHg, severe arrhythmias, and lips or tooth damage.
    Time Frame
    After the DLT intubation
    Title
    Operator satisfaction with intubation
    Description
    Operator satisfaction rating for intubation (range 0-10, with 0 being very dissatisfied and 10 being very satisfied).
    Time Frame
    After the DLT intubation
    Title
    The incidence of low blood oxygen saturation (SpO2<90%) in the post-anaesthesia care unit (PACU)
    Description
    After the patient entered the PACU, the blood oxygen saturation was continuously monitored and the lowest blood oxygen saturation value was recorded.
    Time Frame
    Up to 1 week
    Title
    The incidence of postoperative airway-related complications
    Description
    Postoperative airway-related complications include: sore throat, hoarseness, and nasopharyngeal dryness.
    Time Frame
    1st, 2nd and 3rd day after surgery
    Title
    The incidence of nausea and vomiting
    Description
    Interview patients' subjective feelings, including nausea and vomiting.
    Time Frame
    1st, 2nd and 3rd day after surgery
    Title
    Patient satisfaction with anesthesia
    Description
    Patient satisfaction with anesthesia(range 0-10, with 0 being very dissatisfied and 10 being very satisfied).
    Time Frame
    The first day after surgery
    Title
    Postoperative hospital stay
    Description
    The medical record system queries the number of days in hospital after surgery.
    Time Frame
    Through study completion, an average of 4 weeks
    Title
    The incidence of postoperative complication
    Description
    Postoperative complications included postoperative atelectasis, pneumothorax, pulmonary infection, pleural effusion, bronchopleural fistula and postoperative bleeding.
    Time Frame
    Through study completion, an average of 4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18-60; Patients planning to undergo video-assisted thoracoscopic (VATS) lung surgery requiring DLT intubation; Patients who agreed to participate in this study. Exclusion Criteria: American Society of Anesthesiologists (ASA) classification > IV; Patients with severe nasal obstruction; expected difficult intubation or difficulty with mask ventilation; Morbid obesity [Body Mass Index (BMI)>35kg/m2)]; Airway anatomical abnormalities; Abnormal coagulation function; Emergency surgery; Patients at high risk of reflux aspiration, including ileus, full stomach, esophageal reflux disease; Pregnant or breastfeeding women.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nanbo Luo, MD.
    Phone
    +86-15112389303
    Email
    316916645@qq.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    The research protocol will be announced later in the plan.
    Citations:
    PubMed Identifier
    34105065
    Citation
    Law JA, Duggan LV, Asselin M, Baker P, Crosby E, Downey A, Hung OR, Kovacs G, Lemay F, Noppens R, Parotto M, Preston R, Sowers N, Sparrow K, Turkstra TP, Wong DT, Jones PM; Canadian Airway Focus Group. Canadian Airway Focus Group updated consensus-based recommendations for management of the difficult airway: part 2. Planning and implementing safe management of the patient with an anticipated difficult airway. Can J Anaesth. 2021 Sep;68(9):1405-1436. doi: 10.1007/s12630-021-02008-z. Epub 2021 Jun 8.
    Results Reference
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    PubMed Identifier
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    Citation
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    Results Reference
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    Citation
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    Results Reference
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    Citation
    Renda T, Corrado A, Iskandar G, Pelaia G, Abdalla K, Navalesi P. High-flow nasal oxygen therapy in intensive care and anaesthesia. Br J Anaesth. 2018 Jan;120(1):18-27. doi: 10.1016/j.bja.2017.11.010. Epub 2017 Nov 21.
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    HFNO Improves Blood Oxygen Saturation During Asphyxia During Pulmonary Surgery With Double-lumen Endotracheal Intubation

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