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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06044402
Other study ID # GanSu Province Hospital
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 8, 2023
Est. completion date December 30, 2024

Study information

Verified date September 2023
Source Gansu Provincial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 130
Est. completion date December 30, 2024
Est. primary completion date November 30, 2024
Accepts healthy volunteers No
Gender All
Age group 66 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
group L (Vt 6 ml/kg)
low tidal volume ventilation (tidal volume was set to 6 ml/kg)
group I (Vt 8 ml/kg)
intermediate tidal volume ventilation (tidal volume was set to 8 ml/kg)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
dong zhang

Outcome

Type Measure Description Time frame Safety issue
Primary PaO2/FiO2 the outcome in mmHg the lowest value at one hour after extubation, day-1 to day-3
Primary hypoxemia the outcome in fraction From date of patient admission until the date of discharge, assessed up to 7 days
Primary pneumonia the outcome in fraction From date of patient admission until the date of discharge, assessed up to 7 days
Primary bronchospasm the outcome in fraction From date of patient admission until the date of discharge, assessed up to 7 days
Primary atelectasis the outcome in fraction From date of patient admission until the date of discharge, assessed up to 7 days
Primary pulmonary congestion the outcome in fraction From date of patient admission until the date of discharge, assessed up to 7 days
Primary respiratory failure the outcome in fraction From date of patient admission until the date of discharge, assessed up to 7 days
Primary pleural effusion the outcome in fraction From date of patient admission until the date of discharge, assessed up to 7 days
Primary pneumothorax the outcome in fraction From date of patient admission until the date of discharge, assessed up to 7 days
Primary unplanned requirement for postoperative invasive or noninvasive ventilation the outcome in fraction From date of patient admission until the date of discharge, assessed up to 7 days
Secondary Tidal volume the outcome in milliliter 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)
Secondary respiratory rate the outcome in times/minute (frequency) 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)
Secondary dead space fraction the outcome in 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)
Secondary A-aDO2 the outcome in mmHg 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)
Secondary intrapulmonary shunt the outcome in 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)
Secondary peak airway pressure the outcome in cmH2O 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)
Secondary plateau airway pressure the outcome in cmH2O 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)
Secondary mean airway pressure the outcome in cmH2O 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)
Secondary dynamic compliance the outcome in milliliter/cmH2O 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)
Secondary arterial blood pH the outcome in number 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).
Secondary arterial blood PO2 the outcome in mmHg 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).
Secondary arterial blood PCO2 the outcome in mmHg 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).
Secondary arterial blood Hb the outcome in g/dl 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).
Secondary arterial blood Hct the outcome in 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).
Secondary arterial blood SO2 the outcome in 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).
Secondary arterial blood K the outcome in mmol/L 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).
Secondary arterial blood Na the outcome in mmol/L 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).
Secondary arterial blood Ca the outcome in mmol/L 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).
Secondary arterial blood Cl the outcome in mmol/L 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).
Secondary arterial blood Glu the outcome in mmol/L 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).
Secondary arterial blood Lac the outcome in mmol/L 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).
Secondary arterial blood tBil the outcome in umol/L 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).
Secondary arterial blood SBE the outcome in mmol/L 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).
Secondary arterial blood ABE the outcome in mmol/L 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).
Secondary PaO2/FiO2 the outcome in mmHg 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).
Secondary unplanned intensive care unit admission the outcome in fraction From date of finishing surgery until the date of patient discharge, assessed up to 7 days
Secondary intensive care unit length of stay the outcome in days From date of finishing surgery until the date of patient discharge, assessed up to 7 days
Secondary postoperative mortality the outcome in fraction From date of finishing surgery until the date of patient discharge, assessed up to 7 days
Secondary hospital length of stay the outcome in days From date of patient admission until the date of discharge, assessed up to 10 days
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