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临床试验/NCT07318766
NCT07318766已完成不适用

Effect of Incentive Spirometer on Arterial Blood Gases in Liver Transplant Recipients

Cairo University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年11月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Arterial blood gas (ABG) parameters

研究概览

简要总结

This study evaluated the effect of adjunctive incentive spirometer on arterial blood gases (ABGs) and early postoperative recovery in liver transplant recipients.

详细描述

In this prospective , randomized study, 40 adults undergoing living-donor liver transplantation (LT) were assigned to standard post-transplant mobilization and breathing exercises alone (n=20) or standard exercises plus structured IS training (n=20). Arterial blood gases ABG parameters (pH, PO₂, PCO₂, HCO₃-, SpO₂) were measured at baseline and on postoperative days 1-3. Linear mixed-effects models assessed group differences in ABG trajectories; slope analyses quantified decline and recovery phases. Secondary outcomes included intensive care unit (ICU) and hospital length of stay (LOS) and Post-operative pulmonary complications incidence.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age between 18 and 65 years,
  • scheduled to undergo Living Donor Liver Transplant (LDLT) as recipients
  • able to understand and follow instructions for incentive spirometry use

排除标准

  • multiorgan transplantation
  • moderate-to-severe pleural effusion at baseline
  • persistent elevation in renal function tests
  • history of bleeding esophageal varices within the preceding month
  • multicentric hepatocellular carcinoma (HCC)
  • active smoking
  • decompensated cardiac disease
  • alcoholic hepatitis as the primary etiology
  • cognitive impairment or blindness precluding participation in the rehabilitation protocol.

研究组 & 干预措施

mobilization and breathing exercises alone

No Intervention

Patients in the control group received standard post-transplant mobilization and breathing exercises as per institutional protocol. This included early mobilization, active limb exercises, and deep breathing exercises without the use of an intensive spirometry (IS) device. The exercise regimen was initiated on the first post-operative day and continued throughout the hospital stay.

Incentive Spirometery plus standard exercises

Active Comparator

Patients in the intervention group received structured training on Incentive spirometry (IS) use commencing on the first post-operative day. A tri-flow volumetric IS device was utilized

干预措施: Incentive Spirometry (Device)

结局指标

主要结局

Arterial blood gas (ABG) parameters

时间窗: 3 days (assessed at four time points: baseline (within 48 hours before surgery) and on post-operative days 1, 2, and 3)

Arterial pH

Arterial Blood Gas (ABG) parameters

时间窗: 3 days (assessed at four time points: baseline (within 48 hours before surgery) and at day 1, 2, and 3 post-surgery)

(3) Partial pressure of oxygen (PO2, mmHg)

Arterial Blood Gas (ABG) Parameters

时间窗: 3 days (assessed at four time points: baseline (within 48 hours before surgery) and at day 1, 2, and 3 post-surgery)

(4) bicarbonate concentration (HCO3-, mEq/L)

Arterial Blood Gas (ABG) parameters

时间窗: 3 days (assessed at four time points: baseline (within 48 hours before surgery) and at day 1,2, and 3 post-surgery)

(2) partial pressure of carbon dioxide (PCO2, mmHg)

次要结局

  • length of intensive care unit (ICU) stay(Perioperative period (Hospital stay duration))
  • hospital stay(Perioperative period (Hospital Stay duration))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aya Mohammed Abdel Magid Abdel Hamid

Lecturer of Clinical Pharmacy

Cairo University

研究点 (1)

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