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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Respiratory; Oxygenation; Trendelenburg; Pulmonary; Neumoperitoneum
• Intervention / Treatment: Other: group L (Vt 6 ml/kg); Other: group I (Vt 8 ml/kg)

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: group L; 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.	Other: group L (Vt 6 ml/kg); low tidal volume ventilation (tidal volume was set to 6 ml/kg)
Experimental: group I; 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.	Other: group I (Vt 8 ml/kg); intermediate tidal volume ventilation (tidal volume was set to 8 ml/kg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PaO2/FiO2	the outcome in mmHg	the lowest value at one hour after extubation, day-1 to day-3
hypoxemia	the outcome in fraction	From date of patient admission until the date of discharge, assessed up to 7 days
pneumonia	the outcome in fraction	From date of patient admission until the date of discharge, assessed up to 7 days
bronchospasm	the outcome in fraction	From date of patient admission until the date of discharge, assessed up to 7 days
atelectasis	the outcome in fraction	From date of patient admission until the date of discharge, assessed up to 7 days
pulmonary congestion	the outcome in fraction	From date of patient admission until the date of discharge, assessed up to 7 days
respiratory failure	the outcome in fraction	From date of patient admission until the date of discharge, assessed up to 7 days
pleural effusion	the outcome in fraction	From date of patient admission until the date of discharge, assessed up to 7 days
pneumothorax	the outcome in fraction	From date of patient admission until the date of discharge, assessed up to 7 days
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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
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
postoperative mortality	the outcome in fraction	From date of finishing surgery until the date of patient discharge, assessed up to 7 days
hospital length of stay	the outcome in days	From date of patient admission until the date of discharge, assessed up to 10 days

Collaborators and Investigators

• Sponsor: dong zhang

Study record dates

Study Major Dates

• Study Start (Estimated): October 8, 2023
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: August 24, 2023
• First Submitted That Met QC Criteria: September 12, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Peritoneal Diseases; Pneumoperitoneum
• Other Study ID Numbers: GanSu Province Hospital

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No