Clinical trial NCT06044402: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Trendelenburg
Neumoperitoneum
Oxygenation
Respiratory
Pulmonary
Lead sponsor: Gansu Provincial Hospital
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 130
Sex: ALL
Minimum age (years): 66
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, double-blind, controlled trial
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: PaO2/FiO2
timeFrame: the lowest value at one hour after extubation, day-1 to day-3
measure: hypoxemia
timeFrame: From date of patient admission until the date of discharge, assessed up to 7 days
measure: pneumonia
timeFrame: From date of patient admission until the date of discharge, assessed up to 7 days
measure: bronchospasm
timeFrame: From date of patient admission until the date of discharge, assessed up to 7 days
measure: atelectasis
timeFrame: From date of patient admission until the date of discharge, assessed up to 7 days
measure: pulmonary congestion
timeFrame: From date of patient admission until the date of discharge, assessed up to 7 days
measure: respiratory failure
timeFrame: From date of patient admission until the date of discharge, assessed up to 7 days
measure: pleural effusion
timeFrame: From date of patient admission until the date of discharge, assessed up to 7 days
measure: pneumothorax
timeFrame: From date of patient admission until the date of discharge, assessed up to 7 days
measure: unplanned requirement for postoperative invasive or noninvasive ventilation
timeFrame: From date of patient admission until the date of discharge, assessed up to 7 days
Secondary outcomes:
measure: Tidal volume
timeFrame: 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)
measure: respiratory rate
timeFrame: 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)
measure: dead space fraction
timeFrame: 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)
measure: A-aDO2
timeFrame: 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)
measure: intrapulmonary shunt
timeFrame: 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)
measure: peak airway pressure
timeFrame: 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)
measure: plateau airway pressure
timeFrame: 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)
measure: mean airway pressure
timeFrame: 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)
measure: dynamic compliance
timeFrame: 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)
measure: arterial blood pH
timeFrame: 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).
measure: arterial blood PO2
timeFrame: 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).
measure: arterial blood PCO2
timeFrame: 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).
measure: arterial blood Hb
timeFrame: 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).
measure: arterial blood Hct
timeFrame: 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).
measure: arterial blood SO2
timeFrame: 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).
measure: arterial blood K
timeFrame: 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).
measure: arterial blood Na
timeFrame: 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).
measure: arterial blood Ca
timeFrame: 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).
measure: arterial blood Cl
timeFrame: 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).
measure: arterial blood Glu
timeFrame: 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).
measure: arterial blood Lac
timeFrame: 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).
measure: arterial blood tBil
timeFrame: 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).
measure: arterial blood SBE
timeFrame: 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).
measure: arterial blood ABE
timeFrame: 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).
measure: PaO2/FiO2
timeFrame: 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).
measure: unplanned intensive care unit admission
timeFrame: From date of finishing surgery until the date of patient discharge, assessed up to 7 days
measure: intensive care unit length of stay
timeFrame: From date of finishing surgery until the date of patient discharge, assessed up to 7 days
measure: postoperative mortality
timeFrame: From date of finishing surgery until the date of patient discharge, assessed up to 7 days
measure: hospital length of stay
timeFrame: From date of patient admission until the date of discharge, assessed up to 10 days
Other outcomes:
Locations:
Study officials:
References: