<p>Awake intensive care unit (ICU) patients with endotracheal intubation are exposed to various physiological and psychological stressors due to their medical conditions. As they are unable to communicate verbally, these patients usually struggle to accurately express their needs, which can exacerbate their discomfort and hinder recovery. Our study aimed to develop a needs assessment tool specifically for patients who are awake while intubated to help identify unmet needs promptly. A preliminary needs assessment scale for awake and intubated patients was developed through a systematic literature review and panelist meetings. The scale was refined using two rounds of the Delphi method. A total of 17 and 16 experts participated in two rounds of expert consultation, respectively, during which we gathered their opinions and refined the indicators through a comprehensive literature review and expert panel meetings. This process culminated in developing a needs assessment scale comprising five primary dimensions and 37 secondary items. Subsequently, we conducted a pilot test involving 30 participants, and the results indicated that patients could accurately comprehend each item and independently complete the scale within approximately 10 min. The needs assessment scale developed in this study provides an accurate tool for assessing the needs of awake and intubated ICU patients, demonstrating strong scientific validity and feasibility, thereby providing healthcare professionals with guidance for implementing individualized interventions. Additional research is needed for multi-center, large-sample clinical validation.</p>