Neumoperitoneum, Oxygenation, Pulmonary, Respiratory, Trendelenburg
Conditions
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.
Interventions
OTHERgroup L (Vt 6 ml/kg)
low tidal volume ventilation (tidal volume was set to 6 ml/kg)
OTHERgroup I (Vt 8 ml/kg)
intermediate tidal volume ventilation (tidal volume was set to 8 ml/kg)
Sponsors
dong zhang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
A randomized, double-blind, controlled trial
Eligibility
Sex/Gender
ALL
Age
66 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PaO2/FiO2 | the lowest value at one hour after extubation, day-1 to day-3 | the outcome in mmHg |
| hypoxemia | From date of patient admission until the date of discharge, assessed up to 7 days | the outcome in fraction |
| pneumonia | From date of patient admission until the date of discharge, assessed up to 7 days | the outcome in fraction |
| bronchospasm | From date of patient admission until the date of discharge, assessed up to 7 days | the outcome in fraction |
| atelectasis | From date of patient admission until the date of discharge, assessed up to 7 days | the outcome in fraction |
| pulmonary congestion | From date of patient admission until the date of discharge, assessed up to 7 days | the outcome in fraction |
| respiratory failure | From date of patient admission until the date of discharge, assessed up to 7 days | the outcome in fraction |
| pleural effusion | From date of patient admission until the date of discharge, assessed up to 7 days | the outcome in fraction |
| pneumothorax | From date of patient admission until the date of discharge, assessed up to 7 days | the outcome in fraction |
| unplanned requirement for postoperative invasive or noninvasive ventilation | From date of patient admission until the date of discharge, assessed up to 7 days | the outcome in fraction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mean airway pressure | 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) | the outcome in cmH2O |
| dynamic compliance | 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) | the outcome in milliliter/cmH2O |
| arterial blood pH | 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). | the outcome in number |
| arterial blood PO2 | 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). | the outcome in mmHg |
| arterial blood PCO2 | 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). | the outcome in mmHg |
| arterial blood Hb | 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). | the outcome in g/dl |
| arterial blood Hct | 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). | the outcome in fraction |
| arterial blood SO2 | 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). | the outcome in fraction |
| arterial blood K | 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). | the outcome in mmol/L |
| hospital length of stay | From date of patient admission until the date of discharge, assessed up to 10 days | the outcome in days |
| arterial blood Ca | 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). | the outcome in mmol/L |
| arterial blood Cl | 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). | the outcome in mmol/L |
| arterial blood Glu | 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). | the outcome in mmol/L |
| arterial blood Lac | 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). | the outcome in mmol/L |
| arterial blood tBil | 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). | the outcome in umol/L |
| arterial blood SBE | 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). | the outcome in mmol/L |
| arterial blood ABE | 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). | the outcome in mmol/L |
| PaO2/FiO2 | 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). | the outcome in mmHg |
| unplanned intensive care unit admission | From date of finishing surgery until the date of patient discharge, assessed up to 7 days | the outcome in fraction |
| arterial blood Na | 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). | the outcome in mmol/L |
| intensive care unit length of stay | From date of finishing surgery until the date of patient discharge, assessed up to 7 days | the outcome in days |
| postoperative mortality | From date of finishing surgery until the date of patient discharge, assessed up to 7 days | the outcome in fraction |
| Tidal volume | 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) | the outcome in milliliter |
| respiratory rate | 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) | the outcome in times/minute (frequency) |
| dead space fraction | 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) | the outcome in fraction |
| A-aDO2 | 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) | the outcome in mmHg |
| intrapulmonary shunt | 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) | the outcome in fraction |
| peak airway pressure | 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) | the outcome in cmH2O |
| plateau airway pressure | 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) | the outcome in cmH2O |
Outcome results
None listed