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

N/AUnknownNCT06044402

dong zhang130 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

130

Conditions

Trendelenburg Neumoperitoneum Oxygenation Respiratory Pulmonary

Interventions

group L (Vt 6 ml/kg)OTHER

low tidal volume ventilation (tidal volume was set to 6 ml/kg)

group I (Vt 8 ml/kg)OTHER

intermediate tidal volume ventilation (tidal volume was set to 8 ml/kg)

Eligibility

Sex: ALLMin age: 66 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

PaO2/FiO2

the outcome in mmHg

Time frame: the lowest value at one hour after extubation, day-1 to day-3

hypoxemia

the outcome in fraction

Time frame: From date of patient admission until the date of discharge, assessed up to 7 days

pneumonia

the outcome in fraction

Time frame: From date of patient admission until the date of discharge, assessed up to 7 days

bronchospasm

the outcome in fraction

Time frame: From date of patient admission until the date of discharge, assessed up to 7 days

atelectasis

the outcome in fraction

Time frame: From date of patient admission until the date of discharge, assessed up to 7 days

pulmonary congestion

the outcome in fraction

Time frame: From date of patient admission until the date of discharge, assessed up to 7 days

respiratory failure

the outcome in fraction

Time frame: From date of patient admission until the date of discharge, assessed up to 7 days

pleural effusion

the outcome in fraction

Time frame: From date of patient admission until the date of discharge, assessed up to 7 days

pneumothorax

the outcome in fraction

Data from ClinicalTrials.gov

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NCT06044402 - Different Tidal Volume on Oxygenation, Respiratory Mechanics, and Pulmonary Complications in Older Patients Undergoing Trendelenburg Pneumoperitoneum Surgery | Crick | Crick

Secondary Outcomes

Tidal volume

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)

respiratory rate

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)

dead space fraction

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)

A-aDO2

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)

intrapulmonary shunt

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)

peak airway pressure

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)

plateau airway pressure

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)

mean airway pressure

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)

dynamic compliance

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)

arterial blood pH

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).

arterial blood PO2

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).

arterial blood PCO2

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).

arterial blood Hb

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).

arterial blood Hct

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).

arterial blood SO2

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).

arterial blood K

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).

arterial blood Na

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).

arterial blood Ca

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).

arterial blood Cl

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).

arterial blood Glu

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).

arterial blood Lac

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).

arterial blood tBil

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).

arterial blood SBE

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).

arterial blood ABE

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).

PaO2/FiO2

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).

unplanned intensive care unit admission

the outcome in fraction

Time frame: From date of finishing surgery until the date of patient discharge, assessed up to 7 days

intensive care unit length of stay

the outcome in days

Time frame: From date of finishing surgery until the date of patient discharge, assessed up to 7 days

postoperative mortality

the outcome in fraction

Time frame: From date of finishing surgery until the date of patient discharge, assessed up to 7 days

hospital length of stay

the outcome in days

Time frame: From date of patient admission until the date of discharge, assessed up to 10 days