Nutritional Management in Respiratory Critically Ill Patients -an Observational Study in Mainland China (NM-in-RCIP)

The important role of nutritional management in the treatment of ICU patients has been paid more and more attention. Reasonable nutritional management can improve the nutritional status of patients, reduce the risk of malnutrition, shorten the length of ICU stay, improve the quality of life of patients, and reduce the mortality of patients, thereby improving the prognosis. Many studies have investigated the nutritional status and implementation of ICU patients. It is generally believed that the nutritional status of ICU patients is not good, and the implementation of standardization needs to be improved.The data on the nutritional status and implementation of RICU patients in mainland China is rare. Therefore, the main purpose of this study is to investigate the implementation and compliance of nutritional support treatment for RICU patients in mainland China.

Study Overview

• Status: Recruiting
• Conditions: Nutritional Deficiency

Detailed Description

Respiratory critically ill patients have their own disease metabolism and treatment methods. However, RICU medical staff generally do not pay enough attention to nutrition support treatment. The data on the nutritional status and implementation of RICU patients in China is rare. But the data plays an important role in carrying out nutrition-related research, formulating the goals of continuing education programs for nutrition support treatment, guiding the introduction of medical insurance policies and the revision of consensus. Therefore, the main purpose of this study is to investigate the implementation and compliance of nutritional support treatment for RICU patients in tertiary hospitals in mainland China, so as to lay the foundation for further relevant work.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Xu Huang, M.D.; Phone Number: +86 13641345816; Email: huangxu1122@sina.com
• Study Contact Backup: Name: Qingyuan Zhan, M.D.; Phone Number: 13911785957; Email: drzhanqy@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100028
      • Recruiting
      • China-Japan Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The patients admitted to RICU

Description

Inclusion Criteria:

• patients aged >18 years
• the length of RICU stays >48 hours

Exclusion Criteria:

• patients aged ≤18 years
• the length of RICU stays ≤48 hours
• patients who were admitted to RICU due to or combined with severe trauma or surgery

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of enteral nutrition starting within 48 hours after ICU entry	Proportion of enteral nutrition starting within 48 hours after ICU entry	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional status and risk of malnutrition on ICU admission	To assess nutritional status and risk of malnutrition on ICU admission by NRS-2002 risk score and NUTRIC score	48 hours
The proportion of subjects receiving>80% estimated energy target within 7 days after ICU entry	The proportion of subjects receiving>80% estimated energy target within 7 days after ICU entry	7 days
The proportion of enteral nutrition intolerance	The proportion of enteral nutrition intolerance	48 hours

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Collaborators: Xijing Hospital; Changhai Hospital; The First Affiliated Hospital of Anhui Medical University; The First Affiliated Hospital of Nanchang University; Xiangya Hospital of Central South University; Wuhan University; Peking University People's Hospital; Fudan University; Beijing 302 Hospital; The Second Hospital of Hebei Medical University; Peking University Third Hospital; First Affiliated Hospital, Sun Yat-Sen University; Huashan Hospital; Tongji Hospital; First Affiliated Hospital Xi'an Jiaotong University; Peking University Shougang Hospital; Peking University International Hospital; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; Ruijin Hospital; Beijing Hospital; The First Affiliated Hospital of Soochow University; The First Affiliated Hospital of Zhengzhou University; The Third Xiangya Hospital of Central South University; Shaanxi Provincial People's Hospital; The First Hospital of Jilin University; Henan Provincial People's Hospital; People's Hospital of Xinjiang Uygur Autonomous Region; Xinqiao Hospital of Chongqing; The First Affiliated Hospital of Kunming Medical College; First Hospital of China Medical University; Second Affiliated Hospital of Soochow University; Tianjin Medical University Second Hospital; First Affiliated Hospital of Wenzhou Medical University; Second Xiangya Hospital of Central South University; First Hospital of Shijiazhuang City; Cangzhou Central Hospital; First Affiliated Hospital Bengbu Medical College; Sichuan Provincial People's Hospital; Second Affiliated Hospital of Nanchang University; China Rehabilitation Research Center; Second Hospital of Jilin University; Qingdao Central Hospital; The First Affiliated Hospital of Dalian Medical University; The First People's Hospital of Lianyungang; The Second Hospital of Anhui Medical University; Subei People's Hospital of Jiangsu Province; Yantai Yuhuangding Hospital; Wuxi People's Hospital; Tianjin Chest Hospital; Wuhan Central Hospital; The Affiliated Zhongshan Hospital of Dalian University; Meizhou People's Hospital; Suzhou Municipal Hospital; The First People's Hospital of Changzhou; Hainan People's Hospital; The First People's Hospital of Yunnan; Jiangxi Provincial People's Hopital; The Fourth Affiliated Hospital of China Medical University; Taian City Central Hospital; The General Hospital of Eastern Theater Command; Dongfang Hospital Affiliated to Tongji University; Affiliated Hospital of Chengde Medical University; The First Affiliated Hospital of Hebei North University; Cangzhou People's Hospital; Dezhou People's Hospital; General Hospital of Tianjin Medical University; Dalian Municipal Central Hospital; Beijing Fangshan District Liangxiang Hospital; Jingzhou Central Hospital; The 306 Hospital of People's Liberation Army; Suzhou Hospital of Traditional Chinese Medicine; The Second Affiliated Hospital of Air Force Military Medical University; Heze Municipal Hospital; Zibo First Hospital; The General Hospital of Northern Theater Command; Beijing Jingmei Group General Hospital; The Affiliated Jiangning Hospital of Nanjing Medical University; Longyan First Affiliated Hospital of Fujian Medical University; Beijing Coal Group General Hospital; Beijing Rehabilitation Hospital, Capital Medical University; Huan'an First People's Hospital; Hebei Sheng Xiong Ke Yi Yuan; Affiliated Hospital of North China University of Science and Technology; Tangshan Central Hospital; Zhuozhou Hospital; Affiliated Central Hospital of Shenyang Medical College; Special Medical Center of the Armed Police Force; The Second People Hospital of Wuhu; The General Hospital of Southern Theater Command; Huai an First People Hospital; Nanjing No.1 Hospital; The First Affiliated Hospital of Xi an Medical University; No.2 People Hospital of Fuyang City; Central Command General Hospital; Taikang Xianlin Drum Tower Hospital; The First People Hospital of Nantong City; People Hospital of Dali Bai Autonomous Prefecture; The Sixth Central Hospital of PLA; The Third People Hospital of Datong

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2021
• Primary Completion (ANTICIPATED): July 1, 2021
• Study Completion (ANTICIPATED): August 12, 2021

Study Registration Dates

• First Submitted: March 28, 2021
• First Submitted That Met QC Criteria: July 1, 2021
• First Posted (ACTUAL): July 12, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 12, 2021
• Last Update Submitted That Met QC Criteria: July 1, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Enteral Nutrition; Nutritional Management; Respiratory Critically Ill Patients
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Nutrition Disorders; Critical Illness; Malnutrition
• Other Study ID Numbers: CJFH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No