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Different Tidal Volume on Oxygenation, Respiratory Mechanics, and Pulmonary Complications in Older Patients Undergoing Trendelenburg Pneumoperitoneum Surgery

Primary Purpose

Trendelenburg, Neumoperitoneum, Oxygenation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
group L (Vt 6 ml/kg)
group I (Vt 8 ml/kg)
Sponsored by
dong zhang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trendelenburg

Eligibility Criteria

66 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I-III class; Colorectal cancer patients; Elective laparoscopic colorectal surgery; expected duration of surgery greater than 2 hours. Exclusion Criteria: serious complications associated with other systems; severe cardiac insufficiency; renal failure; body mass index (BMI) greater than 30 kg/m2 or less than 18 kg/m2; the use of low tidal volume and consequent hypercapnia can induce harm; refusal to participate in the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    group L

    group I

    Arm Description

    Ventilation was subsequently changed to individualized positive end-expiratory pressure and recruitment maneuvers during trendelenburg pneumoperitoneum, and the tidal volume was set to 6 ml/kg.

    Ventilation was subsequently changed to individualized positive end-expiratory pressure and recruitment maneuvers during trendelenburg pneumoperitoneum, and the tidal volume was set to 8 ml/kg.

    Outcomes

    Primary Outcome Measures

    PaO2/FiO2
    the outcome in mmHg
    hypoxemia
    the outcome in fraction
    pneumonia
    the outcome in fraction
    bronchospasm
    the outcome in fraction
    atelectasis
    the outcome in fraction
    pulmonary congestion
    the outcome in fraction
    respiratory failure
    the outcome in fraction
    pleural effusion
    the outcome in fraction
    pneumothorax
    the outcome in fraction
    unplanned requirement for postoperative invasive or noninvasive ventilation
    the outcome in fraction

    Secondary Outcome Measures

    Tidal volume
    the outcome in milliliter
    respiratory rate
    the outcome in times/minute (frequency)
    dead space fraction
    the outcome in fraction
    A-aDO2
    the outcome in mmHg
    intrapulmonary shunt
    the outcome in fraction
    peak airway pressure
    the outcome in cmH2O
    plateau airway pressure
    the outcome in cmH2O
    mean airway pressure
    the outcome in cmH2O
    dynamic compliance
    the outcome in milliliter/cmH2O
    arterial blood pH
    the outcome in number
    arterial blood PO2
    the outcome in mmHg
    arterial blood PCO2
    the outcome in mmHg
    arterial blood Hb
    the outcome in g/dl
    arterial blood Hct
    the outcome in fraction
    arterial blood SO2
    the outcome in fraction
    arterial blood K
    the outcome in mmol/L
    arterial blood Na
    the outcome in mmol/L
    arterial blood Ca
    the outcome in mmol/L
    arterial blood Cl
    the outcome in mmol/L
    arterial blood Glu
    the outcome in mmol/L
    arterial blood Lac
    the outcome in mmol/L
    arterial blood tBil
    the outcome in umol/L
    arterial blood SBE
    the outcome in mmol/L
    arterial blood ABE
    the outcome in mmol/L
    PaO2/FiO2
    the outcome in mmHg
    unplanned intensive care unit admission
    the outcome in fraction
    intensive care unit length of stay
    the outcome in days
    postoperative mortality
    the outcome in fraction
    hospital length of stay
    the outcome in days

    Full Information

    First Posted
    August 24, 2023
    Last Updated
    September 12, 2023
    Sponsor
    dong zhang
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06044402
    Brief Title
    Different Tidal Volume on Oxygenation, Respiratory Mechanics, and Pulmonary Complications in Older Patients Undergoing Trendelenburg Pneumoperitoneum Surgery
    Official Title
    Effect of Intraoperative Low Tidal Volume vs Intermediate Tidal Volume on Oxygenation, Respiratory Mechanics, and Pulmonary Complications in Older Patients Undergoing Trendelenburg Pneumoperitoneum Surgery: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 8, 2023 (Anticipated)
    Primary Completion Date
    November 30, 2024 (Anticipated)
    Study Completion Date
    December 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    dong zhang

    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
    The investigators want to assess the effect of intraoperative low tidal volume vs intermediate tidal volume on respiratory mechanics, oxygenation and pulmonary complications in older patients undergoing Trendelenburg pneumoperitoneum surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Trendelenburg, Neumoperitoneum, Oxygenation, Respiratory, Pulmonary

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    A randomized, double-blind, controlled trial
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    130 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    group L
    Arm Type
    Placebo Comparator
    Arm Description
    Ventilation was subsequently changed to individualized positive end-expiratory pressure and recruitment maneuvers during trendelenburg pneumoperitoneum, and the tidal volume was set to 6 ml/kg.
    Arm Title
    group I
    Arm Type
    Experimental
    Arm Description
    Ventilation was subsequently changed to individualized positive end-expiratory pressure and recruitment maneuvers during trendelenburg pneumoperitoneum, and the tidal volume was set to 8 ml/kg.
    Intervention Type
    Other
    Intervention Name(s)
    group L (Vt 6 ml/kg)
    Intervention Description
    low tidal volume ventilation (tidal volume was set to 6 ml/kg)
    Intervention Type
    Other
    Intervention Name(s)
    group I (Vt 8 ml/kg)
    Intervention Description
    intermediate tidal volume ventilation (tidal volume was set to 8 ml/kg)
    Primary Outcome Measure Information:
    Title
    PaO2/FiO2
    Description
    the outcome in mmHg
    Time Frame
    the lowest value at one hour after extubation, day-1 to day-3
    Title
    hypoxemia
    Description
    the outcome in fraction
    Time Frame
    From date of patient admission until the date of discharge, assessed up to 7 days
    Title
    pneumonia
    Description
    the outcome in fraction
    Time Frame
    From date of patient admission until the date of discharge, assessed up to 7 days
    Title
    bronchospasm
    Description
    the outcome in fraction
    Time Frame
    From date of patient admission until the date of discharge, assessed up to 7 days
    Title
    atelectasis
    Description
    the outcome in fraction
    Time Frame
    From date of patient admission until the date of discharge, assessed up to 7 days
    Title
    pulmonary congestion
    Description
    the outcome in fraction
    Time Frame
    From date of patient admission until the date of discharge, assessed up to 7 days
    Title
    respiratory failure
    Description
    the outcome in fraction
    Time Frame
    From date of patient admission until the date of discharge, assessed up to 7 days
    Title
    pleural effusion
    Description
    the outcome in fraction
    Time Frame
    From date of patient admission until the date of discharge, assessed up to 7 days
    Title
    pneumothorax
    Description
    the outcome in fraction
    Time Frame
    From date of patient admission until the date of discharge, assessed up to 7 days
    Title
    unplanned requirement for postoperative invasive or noninvasive ventilation
    Description
    the outcome in fraction
    Time Frame
    From date of patient admission until the date of discharge, assessed up to 7 days
    Secondary Outcome Measure Information:
    Title
    Tidal volume
    Description
    the outcome in milliliter
    Time Frame
    before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)
    Title
    respiratory rate
    Description
    the outcome in times/minute (frequency)
    Time Frame
    before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)
    Title
    dead space fraction
    Description
    the outcome in fraction
    Time Frame
    before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)
    Title
    A-aDO2
    Description
    the outcome in mmHg
    Time Frame
    before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)
    Title
    intrapulmonary shunt
    Description
    the outcome in fraction
    Time Frame
    before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)
    Title
    peak airway pressure
    Description
    the outcome in cmH2O
    Time Frame
    before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)
    Title
    plateau airway pressure
    Description
    the outcome in cmH2O
    Time Frame
    before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)
    Title
    mean airway pressure
    Description
    the outcome in cmH2O
    Time Frame
    before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)
    Title
    dynamic compliance
    Description
    the outcome in milliliter/cmH2O
    Time Frame
    before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3)
    Title
    arterial blood pH
    Description
    the outcome in number
    Time Frame
    before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
    Title
    arterial blood PO2
    Description
    the outcome in mmHg
    Time Frame
    before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
    Title
    arterial blood PCO2
    Description
    the outcome in mmHg
    Time Frame
    before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
    Title
    arterial blood Hb
    Description
    the outcome in g/dl
    Time Frame
    before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
    Title
    arterial blood Hct
    Description
    the outcome in fraction
    Time Frame
    before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
    Title
    arterial blood SO2
    Description
    the outcome in fraction
    Time Frame
    before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
    Title
    arterial blood K
    Description
    the outcome in mmol/L
    Time Frame
    before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
    Title
    arterial blood Na
    Description
    the outcome in mmol/L
    Time Frame
    before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
    Title
    arterial blood Ca
    Description
    the outcome in mmol/L
    Time Frame
    before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
    Title
    arterial blood Cl
    Description
    the outcome in mmol/L
    Time Frame
    before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
    Title
    arterial blood Glu
    Description
    the outcome in mmol/L
    Time Frame
    before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
    Title
    arterial blood Lac
    Description
    the outcome in mmol/L
    Time Frame
    before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
    Title
    arterial blood tBil
    Description
    the outcome in umol/L
    Time Frame
    before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
    Title
    arterial blood SBE
    Description
    the outcome in mmol/L
    Time Frame
    before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
    Title
    arterial blood ABE
    Description
    the outcome in mmol/L
    Time Frame
    before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
    Title
    PaO2/FiO2
    Description
    the outcome in mmHg
    Time Frame
    before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).
    Title
    unplanned intensive care unit admission
    Description
    the outcome in fraction
    Time Frame
    From date of finishing surgery until the date of patient discharge, assessed up to 7 days
    Title
    intensive care unit length of stay
    Description
    the outcome in days
    Time Frame
    From date of finishing surgery until the date of patient discharge, assessed up to 7 days
    Title
    postoperative mortality
    Description
    the outcome in fraction
    Time Frame
    From date of finishing surgery until the date of patient discharge, assessed up to 7 days
    Title
    hospital length of stay
    Description
    the outcome in days
    Time Frame
    From date of patient admission until the date of discharge, assessed up to 10 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    66 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I-III class; Colorectal cancer patients; Elective laparoscopic colorectal surgery; expected duration of surgery greater than 2 hours. Exclusion Criteria: serious complications associated with other systems; severe cardiac insufficiency; renal failure; body mass index (BMI) greater than 30 kg/m2 or less than 18 kg/m2; the use of low tidal volume and consequent hypercapnia can induce harm; refusal to participate in the study.

    12. IPD Sharing Statement

    Learn more about this trial

    Different Tidal Volume on Oxygenation, Respiratory Mechanics, and Pulmonary Complications in Older Patients Undergoing Trendelenburg Pneumoperitoneum Surgery

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