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

Not Applicable

Not yet recruiting

• Conditions: Pulmonary; Trendelenburg; Neumoperitoneum; Respiratory; Oxygenation
• Interventions: Other: group L (Vt 6 ml/kg); Other: group I (Vt 8 ml/kg)

• Registration Number: NCT06044402
• Lead Sponsor: dong zhang

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-24
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-12
• Last Update Submitted: 2023-09-12
• Study First Posted: 2023-09-21
• Last Update Posted: 2023-09-21
• Study Start: 2023-10-08
• Primary Completion: 2024-11-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 130

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group L	group L (Vt 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 6 ml/kg.
group I	group I (Vt 8 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.

Primary Outcome Measures

Name	Time	Method
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
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
PaO2/FiO2	the lowest value at one hour after extubation, day-1 to day-3	the outcome in mmHg
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

Secondary Outcome Measures

Name	Time	Method
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
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
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
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
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
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 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
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
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 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
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 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 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 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 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 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
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
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 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
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
hospital length of stay	From date of patient admission until the date of discharge, assessed up to 10 days	the outcome in days